DRAFT FOR CONSULTATION
APPENDIX D: CHARACTERISTICS OF INCLUDED STUDIES
D1: PREOPERATIVE SHOWERING
Clinical Effectiveness
Study
Participants
Interventions
Byrne
(1992)
Scotland
Inclusion: Patients admitted to surgical
wards for clean or potenitally
contaminated surgery
Exclusion: Day care surgery;
emergency surgery; reoperation within
1 month of previous surgery; operations
on septic conditions; unable to comply
with whole body wash; allergy to
chlorhexidine; >the normal 3 doses of
prophylactic antibiotics
Interventions: 3 pre-operative showers with
chlorhexidine or placebo
Outcomes
Outcomes:
Surgical site infection rate (discharge of pus from a wound
and ASEPSIS score >10; this scale comprises serous
exudate, erythema, purulent exudate and separation of
deep tissues, antibiotics, drainage of pus, debridement of
wound, isolation of bacteria from wound swab, in-patient
stay >14 days):
256/1498 (14.6%) in chlorhexidine group
272/1463 (15.7%) in placebo group
Baseline comparability: Yes
Earnshaw
(1989)
UK
Hayek
(1988)
UK
Inclusion: 64 patients having 66
vascular reconstructions (54 men + 10
women)
Exclusion: None stated
Baseline comparability: Yes
Inclusion: All 2015 patients admitted for
routine surgery
Exclusion: Receiving antibiotics or
intercurrent infection
Interventions: 2 pre-operative antiseptic chlorhexidine
baths vs. 2 pre-operative baths using non-medicated
soap
Outcomes:
Surgical site infection rate (discharge of pus or severe
cellulitis requiring antibiotics):
8/31 (26%) in chlorhexidine group
4/35 (11%) in control group; p=0.12
Interventions: Chlorhexidine scrub (n=689), placebo
(n=700) or plain bar soap (n=626) used twice in bath
or shower
Outcomes:
Surgical site infection rate (significant discharge of pus or
area of erythema or swelling greater than expected;
assessed by ward staff):
80/626 (12.8%) in soap group
83/700 (11.7%) in placebo group
62/689 (9%) in chlorhexidine group
p<0.05 for chlorhexidine vs. soap and chlorhexidine vs.
placebo
Baseline comparability: Yes
Surgical site infection: full guideline DRAFT (April 2006)
Page 390 of 599
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Study
Participants
Interventions
Outcomes
Rotter
(1988)
Multinationa
l European
Inclusion: Patients undergoing elective
clean surgery
Exclusion: Fever, clinical signs and
symptoms, or antibiotic treatment, of
infection remote from site of operation,
incarcerated inguinal hernia, radical
mastectomy
Interventions: Detergent with (n=1413) or without
(n=1400) chlorhexidine, used twice in bath
Outcomes:
Surgical site infection rate (inflammation of the surgical
wound with discharge of pus, spontaneous and/or after
surgical intervention that occurs during hospitalisation or
during routine follow-up):
37/1413 (2.62%) in chlorhexidine group
33/1400 (2.36%) in no chlorhexidine group
RR 1.11 (95% CI 0.69-1.82)
Interventions: Whole body disinfection with
chlorhexidine soap in a shower (ward 1), vs. local
washing with chlorhexidine soap only to part of body
to be submitted to surgery (ward 2), vs. no washing
with chlorhexidine soap (ward 3).
Outcomes:
Surgical site infection rate (definite collection of pus
emptying itself spontaneously or after incision):
9/541 (1.7%) in ward 1
23/552 (4.2%) in ward 2
20/437 (4.6%) in ward 3
Baseline comparability: Yes
Wihlborg
(1987)
Sweden
Inclusion: clean surgery
Exclusion: Common bile duct surgery
Baseline comparability: Yes
Ward 1 vs. ward 2: p<0.05
Ward 1 vs. ward 3: p<0.01
Surgical site infection: full guideline DRAFT (April 2006)
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Cost-effectiveness (Preoperative showering)
Study
Lynch et al.
1992
Methods
Cost minimisation analysis.
Clinical effectiveness
Double-blind, placebocontrolled randomised
controlled trial (n=3,482).
Follow-up: until healing of
wound.
Outcomes studied: bacterial
count after 3rd shower, and
surgical wound infection
Population
Patients
attending
elective surgery.
Costing
Undertaken prospectively.
Costs included: drugs,
length of stay, dressings,
and visits to GP and district
nurses. The authors
reported that the costs of the
placebo and chlorhexidine
detergent were not included.
Price year not reported.
Costs & quantities not
reported separately.
Surgical site infection: full guideline DRAFT (April 2006)
Interventions
Intervention
Three showers (on
admission to hospital,
before going to bed,
morning of the
operation) with a 4%
chlorhexidine
detergent solution
(n=1,744).
Comparator
Three showers with
placebo detergent
(n=1738).
Results
Effectiveness
Mean bacterial score:
Chlorhexidine: 8.6
Placebo: 12.6 (p<0.0001)
Wound infection rates:
Chlorhexidine: 250/1744
(14.33%)
Placebo: 263/1738
(15.33%, p not
significant)
Costing
Chlorhexidine: £963 per
patient
Placebo: £897 per patient
Synthesis of costs &
benefits
Not relevant, as both
antiseptics were found
equally effective and
placebo was cheaper
Conclusions
The authors
concluded that
preoperative wholebody disinfection with
a chlorhexidine
detergent was not a
cost-effective
treatment for reducing
wound infection.
Comments
The possible effects of
confounding (such as
type of surgery
performed) were
controlled in the study
as patients were
matched for age, sex,
surgeon, and type of
operation.
The authors however,
did not include the costs
of chlorhexidine or
placebo detergents in
the analysis. In the
costing analysis, the
authors only included
dressing and outpatient
costs for the last 2,000
patients randomised to
the study. It is unclear if
the differences in mean
costs between the two
patient groups are
statistically significant.
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D2: PREOPERATIVE HAIR REMOVAL
Clinical Effectiveness
Study
Alexander
1983
Participants
Inclusion: 1,013 patients
undergoing elective major
operations
Exclusion: Dirty wounds,
proctologic procedures,
skin grafts, operations on
genitalia, head or hand,
amputations of toe or foot,
operations for decubitus
ulcers.
Baseline comparability:
Yes
Interventions
1) Pre-operative shaving the night before the operation
2) Pre-operative shaving the morning of the operation
3) Clipping the night before the operation
4) Clipping on the morning of the operation
Outcomes and results
Wound infection rate (discharge of pus) defined by research
nurse, confirmed by doctor:
At discharge from hospital:
At 30 days:
1) 14/271 (5.2%)
23/260 (8.8%)
2) 17/266 (6.4%)
26/260 (10.0%)
3) 10/250 (4.0%)
18/241 (7.5%)
4) 4/226 (1.8%)
7/216 (3.2%)
Divided by type of infection (at discharge only):
1) 2 stitch abscess, 8 superficial abscess, 4 deep abscess
2) 4, 5 and 8
3) 1, 6 and 3
4) 0, 3 and 1
Divided by type of wound: Clean wounds:
At discharge from hospital:
At 30 days:
1) 8/160 (5.0%)
15/153 (9.8%)
2) 6/152 (4.0%)
13/148 (8.8%)
3) 5/149 (3.4%)
10/145 (6.9%)
4) 2/143 (1.4%)
3/137 (2.2%)
Clean-contaminated or contaminated wounds:
At discharge from hospital:
At 30 days:
1) 6/111 (5.4%)
8/107 (7.5%)
2) 11/114 (9.6%)
13/112 (11.6%)
3) 5/101 (5.0%)
8/96 (8.3%)
4) 2/83 (2.4%)
4/79 (5.1%)
Length of stay: Not described for each group separately, only
according to whether the patient had an infection or not.
Surgical site infection: full guideline DRAFT (April 2006)
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Study
Participants
Interventions
Outcomes and results
Balthazar,
Colt &
Nichols
1981
USA
Inclusion: 200 males undergoing
elective inguinal herniorophy
Exclusion: incarcerated or
strangulated hernias; patients
requiring preoperative
antibiotics; patients using local
anaesthetics.
Age Range: 22-81yrs
1.Wet shave with soap & water immediately prior to surgery
2.clipping with barbers electric clippers immediately
Surgical procedure, wound closure & dressing subject to study
protocol.
Outcomes: Wound infection defined as : wound with purulent
exudates
Assessed by infection control nurse day 5 & 14 post operation
confirmed with swab sent for C&S
Inclusion: 406 patients having
abdominal operations (elective
or emergency)
Exclusion: Colostomy
Baseline comparability: No –
authors do not discuss this, but
using skin preparation <6 hours
in advance of operation as a
proxy of emergency operation,
from Table 4, 26% of cream
patients were emergencies vs.
42% of shave patients (‘no
preparation’ patients could not
be compared on this measure so
cannot assess how many were
emergency operations)
Loss to follow-up: 12 of original
418 patients excluded from
analysis as they died within 28
days of operation (2.9%)
1) Wet shave with disposable razor (elective 18-24 hours before
surgery; emergency within 6 hours)
2) Depilatory cream (Veeto) (elective 18-24 hours before
surgery; emergency within 6 hours)
3) No pre-operative skin preparation
CourtBrown 1981
2/100 of Shave Group developed infection (1 staph aureus, 1
staph epidermidis)
1/100 Clipped Group developed infection (staph aureus)
Difference between groups not statistically significant.
Wound sepsis (discharged material from which bacteria were
cultured)
Overall:
1) 17/137 (12.4%)
2) 10/126 (7.9%)
3) 11/141 (7.8%)
Not significantly different
Divided by type of wound: Clean wounds:
1) 4/38; 2) 0/29; 3) 1/34
Clean-contaminated wounds:
1) 8/77; 2) 4/74; 3) 2/69
Contaminated wounds:
1) 1/11; 2) 3/13; 3) 3/13
Dirty wounds:
1) 4/11; 2) 3/10; 3) 5/25
Authors compare total infections in ‘Clean + Cleancontaminated’ and found more in the shave group than in the
other 2 groups (p<0.05) but not clear whether this was an a prior
hypothesis (other authors combine clean-contaminated with
contaminated group rather than clean group).
Surgical site infection: full guideline DRAFT (April 2006)
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Study
Participants
Interventions
Outcomes and results
Hoe &
Nambiar
1985
Singapore
Inclusion: 829 (123 excluded
due to incomplete data. 706
participants undergoing elective
surgery
Exclusion: not stated
Age range: 2 – 85 yrs
Baseline comparability: Yes
Follow up: 15.2% drop-out
Inclusion: patients requiring
standard incisions for surgical
treatment of tumour & vascular
anomalies
Exclusion: not stated
Age range: not given
Follow up: 6 months
Wet shave night prior to surgery
Outcomes: Wound infection
Wound infection assessment criteria: No details given
Infection assessor: No details given
Days post op wounds assessed: no details given
Results: 20/361 Shave group developed wound infection
(5.08%), 28/354 Non shave group developed infection (5.56%).
Not statistically significant.
Horgan
1999
Rojanapirom
1992
Thailand
Inclusion: Patients over 12yrs
with acute appendicitis (n=80)
Exclusion: underlying comorbidity.
Age range: 13-60+yrs
Loss to follow up: not stated
Baseline comparability: not
stated
Primary Outcome: rates of
surgical wound infection
Savlon Baths x 2 night prior to surgery & morning of surgery.
Concordant Treatment: Povidone-iodine applied to skin in non
shave group. Left to dry for 4 mins.
1. Scalp Shave prior to surgery (n=10)
2. Hair wash with 4% chlorhexadine shampoo + Iodphor
detergent scrub + application of betadine paint to incision line by
surgeon (n=10)
1) Skin preparation with 4% chlorhexadine scrub prior to shaving
of skin(n=40)
Outcome 1: Wound infection
Wound infection assessment criteria: No details given
Infection assessor: No details given
Days post op wounds assessed: no details given
Result: No wound infections in either group.
Outcome 2: Patient Satisfaction
Result: Informal enquiry in Hair wash group stated high levels of
satisfaction.
Wound Infection: not defined
Assessed at 48 & 72 hours & 7-10 days post op.
Assessor: not stated
2) Skin preparation with 4% chlorhexadine scrub with no shaving
(n=40).
Stitch abscesses: Control- 3 Experimental:3
Major wound infection: Control-0 Experimental:0
Surgical site infection: full guideline DRAFT (April 2006)
Conclusion:Skin shaving is time consuming & renders no benefit
to rates of surgical wound infection in appendicectomy patients.
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Study
Participants
Interventions
Outcomes and results
Seropian
1971
Inclusion: 406 patients having
operations (184 emergency +
222 elective)
Exclusion: Skin not incised;
burns/skin grafts; proctologic
procedures; excision of toenail
or fingernail; circumcision;
incision and drainage of
superficial abscess; operations
limited to vagina; operations
resulting in death in operating
room; no skin preparation for
hair removal (e.g. children)
Baseline comparability: Larger
proportion of males in the razor
group than in the cream group
(63% v. 47%) but accounting for
this, the difference between the
groups would be more rather
than less.
Inclusion: 253 men having
elective general surgical
operations who required hair
removal
Exclusion: Not stated
Baseline comparability: Not
stated
Loss to follow-up: Not stated
1) Standard razor preparation (127 just prior to surgery; 112
‘routine’, i.e. up to 24 hours in advance; 10 over 24 hours in
advance)
2) Depilatory cream (Surgex) (58 just prior to surgery; 94 routine
and 5 over 24 hours in advance)
Wound infection (not defined)
1) 14/249 (5.6%)
2) 1/157 (0.6%), p=0.02
Divided by type of wound:
Clean wounds:
1) 4/82; 2) 0/66
Clean-contaminated wounds:
1) 6/72; 2) 0/35
Contaminated and dirty wounds
1) 4/95; 2) 1/56
Thur de
Koos 1983
Divided by time of preparation prior to surgery:
Just prior to surgery:
1) 4/127 (3.1%); 2) 0/58
Routine preparation (in 24 hours prior to surgery):
1) 8/112 (7.1%); 2) 1/94
1) Wet shave immediately before operation (30 minutes before
in operating room)
2) Depilatory cream (Neet) on the day before surgery in the ward
rooms
Surgical site infection: full guideline DRAFT (April 2006)
Over 24 hours prior to surgery:
1) 2/10 (20%); 2) 0/5
Wound infection (not defined):
1) 10/137
2) 9/116
Divided by type of wound:
Clean wounds:
1) 4/71 (5.6%)
2) 3/58 (5.2%
Clean-contaminated wounds:
1) 2/51 (3.9%)
2) 2/50 (4.0%)
Contaminated wounds:
1) 1/6 (16.6%)
2) 2/6 (33.3%)
Infected at baseline wounds:
1) 3/9 (33.3%)
2) 2/2 (100%)
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Cost-effectiveness evidence table- Pre-operative hair removal
Study
Alexander
et al. (1983)
CourtBrown
(1981)
Methods
Cost-consequence analysis.
Clinical effectiveness
Randomised controlled trial
(n=1,013). Outcomes studied: rate
of surgical wound infections at
hospital discharge and at 30 days
follow-up. The authors stratified
results by clean, cleancontaminated and contaminated
surgery.
Costing
Undertaken prospectively.
Costs included: costs of treating
SSIs. Length of stay and total
costs were compared for infected
patients and their matched
controls. Costs and quantities
were reported separately.
Cost-consequence analysis.
Clinical effectiveness
Randomised controlled trial
(n=406). Outcomes studied: rate of
surgical wound infections and
acceptability to patients. The
authors stratified results by clean,
clean-contaminated, contaminated
and dirty surgery.
Population
Patients
scheduled
to receive
elective,
major
operations.
Interventions
1) Routine shaving
the night before the
operation.
2) Routine shaving
the morning of the
operation.
3) Clipping of hair
the night before the
operation.
4) Clipping of hair
the morning of the
operation.
Results
Effectiveness
Surgical wound infection rate, at discharge (at 30 day
follow-up):
Shaving day before: 5.2% (8.8%)
Shaving morning: 6.4% (10%)
Clipper day before: 4.0% (7.5%)
Clipper morning: 1.8%, p=0.27 (3.2%, p=0.006)
Costing
655.8 days of hospitalisation per 1,000 patients treated
would have been avoided if clipping hair in the morning
of the operation would have been used exclusively.
This generated cost savings of $274,780 per 1,000
patients treated.
Conclusions
The authors
concluded that
if pre-operative
shaving was
abandoned, the
annual savings
in the USA
could be more
than $3billion.
Comments
The costing study did not
include the costs of preoperative hair removal.
However, it is unlikely
that inclusion of these
costs would have altered
the authors’ conclusions.
In the analysis of
effectiveness surgical
wound infection at 30
days was reported by the
patient. It is unclear if
these reports were
verified by the research
staff in the study.
The authors
concluded that
pre-operative
skin preparation
was not
essential, but
that if in
preparation for
surgery hair
must be
removed,
depilatory
cream should
be the agent of
choice.
The costing study did not
include staff time costs,
which are important as
the time spent by the
health care professional
removing hair from the
patient will vary between
the different preoperative hair removal
interventions.
Synthesis of costs and benefits
Not applicable.
Patients
undergoing
abdominal
surgery.
Costing
Undertaken prospectively.
Costs included: costs of hair
removal materials. Costs and
quantities were not reported
separately.
Surgical site infection: full guideline DRAFT (April 2006)
1) No hair removal
(n=141)
2) Hair removal with
depilatory cream
(n=126)
3) Hair removal with
disposable razor
(n=137)
Effectiveness
Surgical wound infection rate:
Razor 12.4% (17/137)
Cream 7.9% (10/126)
No preparation 7.8% (11,141; p>0.05)
However, there was a significant increase in the number
of wound infections in the clean and cleancontaminated surgery groups of the razor group
(p<0.05).
Costing
Costs of hair removal (per 100 patients)
Razor: £14
Cream: £22
Synthesis of costs and benefits
Not undertaken.
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Study
De Geest et
al. (1996)
Methods
Cost-consequence analysis.
Clinical effectiveness
Descriptive pilot study (n=82).
Outcomes studied: rate of
macroscopic skin lesions
standardised by hair growth.
Costing
Undertaken prospectively.
Costs included: costs of hair
removal materials, and staff time
costs. Costs and quantities were
reported separately.
Hamilton et
al. (1977)
Cost-consequence analysis.
Clinical effectiveness
Prospective cohort study (n=160).
Outcomes studied: number of
wound infections and degree of
erythema.
Population
Patients
undergoing
coronary
artery
bypass
graft
(CABG)
surgery.
Patients
undergoing
surgery.
Costing
Undertaken prospectively.
Costs included: costs of hair
removal materials. Costs and
quantities were not reported
separately.
Surgical site infection: full guideline DRAFT (April 2006)
Interventions
1) Hair removal with
depilatory cream
(n=19)
2) Hair removal with
electric clipper (n=29)
3) Hair removal with
disposable razor
(n=34)
1) No hair removal
(n=41)
2) Hair removal with
depilatory cream
(n=32)
3) Hair removal with
electric clipper (n=31)
4) Hair removal with
disposable razor
(n=56)
Results
Effectiveness
The rate of macroscopic lesions was:
Cream 0%
Clipper 13.8%
Razor 20.6%
Costing
Median Costs of hair removal per patient:
Clipper: $9.84
Razor: $6.13
Cream: $8.16
Synthesis of costs and benefits
Not undertaken.
Effectiveness
Number of superficial wound infections: no removal 2,
depilatory 2, clipper 3 and razor 4.
Number of deep wound infections: no removal 1,
depilatory 0, clipper 0 and razor 2.
Costing
2
Costs of hair removal (/m /1000 patients/year):
Clipper: $4.95
Razor: $11.40
Cream: $56.70
Conclusions
The authors
concluded that
changing to a
clipper and/or
cream
protocol would
generate
substantial
cost savings in
the long-term.
Comments
The study design was
based on a series of
case studies. However,
the authors did
standardise their costs
and effectiveness
results by hair growth.
The costing study was
complete and
comprehensive, as it
included all relevant
costs likely to vary
between interventions.
The authors
concluded that
if in
preparation for
surgery hair
must be
removed,
depilatory
cream should
be the agent
of choice.
It is unclear what study
design was used by the
authors to compare the
different interventions.
The costing study did
not include staff time
costs, which are
important as the time
spent by the health
care professional
removing hair from the
patient will vary
between the different
pre-operative hair
removal interventions.
Synthesis of costs and benefits
Not undertaken.
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Study
Methods
Population
Interventions
Powis et al.
(1976)
Cost-consequence analysis.
Clinical effectiveness
Randomised controlled trial (n=92).
Outcomes studied: wound infection
rates, colony counts, wound swab
results, and patient acceptability.
Patients
undergoing
surgery
that
required
removal of
hair from
the
operative
site.
1) Conventional
shaving (n=46)
Costing
Undertaken prospectively.
Costs included: costs of hair
removal materials and staff costs.
Costs and quantities were not
reported separately.
Surgical site infection: full guideline DRAFT (April 2006)
2) Hair removal with
depilatory cream
(n=46)
Results
Conclusions
Comments
Effectiveness
The incidence of wound infection was similar between the
two groups.
The number of Staph aureus colony counts was
significantly lower in the depilation group than in the
shaved group (p<0.05).
The authors
concluded that
depilation was
associated
with significant
reductions in
skin surface
bacteria and
proved to be
cheaper than
shaving.
It is unclear how
surgical wound
infection was defined in
the study.
The authors included
all the relevant costs in
their economic
analysis. However, the
authors did not report
separately estimates of
resource use such as
time needed for hair
removal in each of the
two interventions.
Costing
Costs of hair removal:
Depilatory cream: £0.25
Shaving: £0.80
Synthesis of costs and benefits
Not undertaken.
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D3: MECHANICAL BOWEL PREPARATION FOR ELECTIVE COLORECTAL SURGERY
Clinical Effectiveness
Study
Participants
Interventions
Outcomes and results
Brownson
1992
Inclusion criteria: patients
undergoing elective colorectal
surgery. Exclusion criteria: no
details. Diseases: colorectal
cancer: 164/179; other: 14/179.
Number of participants: 179.
Age: no details. Location of
study: Liverpool, UK. Antibiotics:
perioperative intravenous (no
more details).
A: Mechanical bowel preparation (n=86)
B: No preparation (n=93)
Wound infection:
A=5/86, B=7/93
Intra-abdominal sepsis: A=8/86, B=2/93
Anastomotic leakage:
A: 8/67*, B: 1/67*
*Patients whom bowel continuity was restored.
Bucher
2003
Elective left-sided colorectal
surgery Exclusion criteria:
immunosuppression, HIV
infection and liver cirrhosis,
tumours smaller than 2cm;
patients requiring diverting
stoma proximal to the
anastomosis.
Age 18 y or more
Location of study: Switzerland
A: Mechanical Bowel Preparation, 3 litres Polyethylene glycol
12-16 h before surgery (N=78)
Anastomotic leakage and wound infection (primary outcomes)
B: No preparation, (N = 75)
All patients received broad spectrum iv antibiotics for at least
24h after surgery
Surgical site infection: full guideline DRAFT (April 2006)
Non-infectious abdominal compliations, extra-abdomicanl
complications, duration of postoperative ileus, length of hospital
stay.
Wound abscess defined as a wound requiring partial or
complete opening for drainage of a purulent collection, or
erythema requiring initiation of antibiotic treatment.
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Study
Participants
Interventions
Outcomes and results
Burke 1994
Inclusion criteria: patients
admitted for elective colorectal
surgery with primary
anastomosis.
Exclusion criteria: any patients
who could not tolerate the
preparation; patients who had
had the bowel 'prepared' for
another procedure within
previous week.
Diagnoses: 72% colorectal
cancer (133/186 cases); 3%
inflammatory bowel disease
(6/186 cases); 14% diverticular
disease (26/186 cases); 2%
other (4/186 cases).
Number: 186 (95 male; 74
female; 17 undetermined).
Age: mean 64 years.
Location of study: Dublin,
Ireland.
Time: October, 1988 September, 1992.
a) Mechanical bowel preparation group (n = 82): sodium
picosulphate 10 mg, the day before surgery (dose at morning
and afternoon).
a) Death: A=2; B=0.
b) Cardio respiratory: A=8; B=9.
c) Wound infection: A=4; B=3.
d) Anastomotic dehiscence: A=3; B=4.
e) Reoperation: A=2; B=4.
Colorectal Surgery
A) Mechanical Bowel Preparation - Polyethylene glycol
Fa-Si-Oen
2003
b) Group B (n= 87): a normal diet and no other bowel
preparation.
Antibiotics: Ceftriaxone 1 gr and metronidazole 500 mg
intravenously starting at induction of anaesthesia. Metronidazole
500 mg: 8 and 16 h, after initial doses.
Anastomotic leakage, Wound Infection
B: No cleansing
Surgical site infection: full guideline DRAFT (April 2006)
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Study
Participants
Interventions
Outcomes and results
Fillmann
1995
Inclusion criteria: patients
admitted for elective colorectal
surgery with primary
anastomosis.
Exclusion criteria: no exclusions.
Diseases: colorectal cancer
(21:22); diverticular disease
(05:06); inflammatory bowel
disease (02:02); Chron disease
(01:00); ischaemic colitis (00:01).
Number: 60 (33 male; 27
female).
Age: 31-82 years.
.
.
Group A -Mechanical bowel preparation (n= 30): 500 ml mannitol
20% + 500 ml orange juice.
Group B (n= 30): orange juice.
Wound infection: A=1; B=2.
Peritonitis: A=2; B=1.
Extra-abdominal complications (non-infections): -Mechanical
obstruction: A=0; B=1. -Dehiscence of wall suture: A=0; B=1. Pulmonary embolism: A=1; B=0. Extra-abdominal complications
(infections): - Pneumonia: A=1; B=1. - Urinary infection: A=1;
B=2.
Inclusion criteria: all consecutive
adults admitted for elective
colorectal surgery.
Exclusion criteria: patients who
had had bowel preparation for
colonoscopy one week before
surgery (n=5); patients who
where unable to drink PEG-ELS
(n=2); patients not requiring
opening of the bowel (n=4);
patient who refused to be
randomised (n=1).
Disease: colorectal cancer
(134/267); benign tumours
(24/267); inflammatory bowel
disease (32/267); diverticular
disease (58/267); other (19/267).
Number: 267 (130 male; 137
female). Age: 16-97 years.
Group A - Mechanical bowel preparation (n=138): Polyethylene
glycol electrolyte solution, and no solid food on the preoperative
day.
Group B (n=129): no preparations and normal diet.
Time:
1992-1993
Location:
Porto
Alegre, RS
- Brazil
Miettinen
2000
Location:
Kuopio +
Oulu,
Finland.
Time: 19941996.
Antibiotics: metronidazole + gentamycin 1 hour before surgery,
and during 48 hours.
Antibiotics: ceftriaxone 2 gr + metronidazole 1 gr at the induction
of anaesthesia.
Surgical site infection: full guideline DRAFT (April 2006)
Wound infection: A=5; B=3.
Anastomotic leakage: A=5; B=3.
Abdominal abscess: A=3; B=4.
Non-infection postoperative complication: A=11; B=6.
Reoperation: A=4; B=2.
Extra-abdominal infections: A=4; B=2.
Postoperative stay (range/days): A=8; B=8.
Operation time (range/min): A=120; B=110.
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Study
Participants
Interventions
Outcomes and results
Santos
1994
Inclusion criteria: Patients
admitted for elective colorectal
surgery.
Exclusion criteria: patients that
had taken antibiotics for at least
15 days before surgery or if
there was evidence of infection
or any associated disease
requiring antibiotic therapy; and
patients that the mechanical
bowel preparation was not
feasible.
Group A: 5 patients were
excluded: associated infectious
disease (2 patients), and failure
to achieve full mechanical bowel
preparation (3 patients).
Group B: 3 patients excluded: an
intra-abdominal foreign body
found during the operation (1
patient), and urinary tract
infection (2 patients).
Diseases: 43% colorectal cancer
(68/157); 34% mega colon
(53/157); 6% inflammatory bowel
disease (9/157); 3% diverticular
disease (5/157); 2% familial
adenoma polyposis (3/157); 7%
other (11/157).
Number: 157 (72 male; 77
female; 8 undetermined).
Age: 1 - 93 years.
Group A - Mechanical bowel preparation (n= 72):
LAXATIVE (mineral oil, agar and phenolphthalein) 15 ml taken
by mouth three times a day for 5 days before surgery; mannitol
(1 litre as a 10% solution) taken by mouth at the rate of 100 ml
per 5 min at 16:00 hours on the day before surgery.
ENEMA (water, 900 ml; glycerin, 100 ml) given once a day for 2
days before surgery.
children: enema of water and glycerin (9:1) twice a day for 2
days before surgery.
Group B (n= 77): a low-reside diet and no other mechanical
bowel preparation.
Wound infection: A=17; B=9. Anastomotic dehiscence: A=7;
B=4.
Hospital stay (preoperative): A=2-34; B=0-90. Reoperation: A=4;
B=1.
Microbiology (bacteria isolated):
-Bowel content: A=211/62; B=261/72.
-Peritoneal fluid: A=116/62; B=134/72.
-Wounds: A=38/17; B=17/7.
Location:
Ribeirão
Preto, São
Paulo Brazil.
Time:
October,
1991 December,
1992.
Antibiotics: Cephalothin 2 gr and metronidazole 1 g
intravenously at 2 h before induction of anaesthesia.
Cephalothin 1 gr was given 6 and 12 h, and metronidazole 500
mg, 8 and 16 h after the initial dose.
Surgical site infection: full guideline DRAFT (April 2006)
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Study
Participants
Interventions
Outcomes and results
Tabusso
2002
Inclusion criteria: patients with
colorectal cancer, submitted an
elective colorectal surgery.
Exclusion criteria: no details.
Diseases: colorectal cancer.
Participants: 47 (21 male, 26
female). Age: 22 - 87. Location
of study: Lima, Peru. Time:
October 1999 - January 2001.
Antibiotics: against anaerobic
and Gram negative bacteria,
intravenous, 30 minutes before
surgery
Group A - Mechanical bowel preparation (n=24): mannitol or
polyethylene glycol electrolyte solution + liquid diet 48 hours
before surgery.
Group B - No mechanical bowel preparation (n=23): liquid diet
48 hours before surgery.
Wound infection: A=2; B=0.
Anastomotic leakage: A=5; B=0.
Peritonitis: A=3; B=0.
Zmora
2003
Inclusion criteria:
Patients admitted for elective
colon and rectal surgery
Exclusion criteria:
Not described
Group A Mechanical bowel preparation (n= 187) with polyethylene glycol
Group B No preparation (n= 193)
Overall Infection:
A=19; B=17.
Wound Infection:
A=12; B=11.
Anastomotic leak:
A=7; B=2
Intraabdominal Abscess:
A=2, B=2
Surgical site infection: full guideline DRAFT (April 2006)
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D4B: REMOVAL OF NAIL POLISH AND FINGER RINGS TO PREVENT SURGICAL INFECTION
Clinical effectiveness
Study
Participants
Interventions
Outcomes
Wynd et al
102 placed randomly in three groups of
34. Circulating and scrub nurses. No
attempt to standardise nail length.
Surgical scrub observation test based
on a modified hand scrub protocol
applied to attempt to standardise
procedure.
Group 1 fresh nail polish applied within 2 days. Group 2
chipped nail polish applied 4 days before data collection.
Group 3, natural nails
Nails swabbed for colony forming unit’s pre and post
surgical scrub, using sterile cotton tipped applicators.
Surgical site infection: full guideline DRAFT (April 2006)
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D6: SURGICAL SCRUBBING TO REDUCE SURGICAL SITE INFECTION
Clinical effectiveness
Study
Participants
Interventions
Outcomes
Parienti
2002
Inclusion: 4387 consecutive patients
undergoing clean or cleancontaminated surgery at 6 surgical
services from teaching and nonteaching hospitals in France.
Exclusion: contaminated or dirty
procedures; second operation within 15
days
Baseline comparability: Yes
Loss to follow-up: 51 (1%)
Interventions:
2 hand-cleansing methods alternately every other
month:
a hand-rubbing protocol with 75% aqueous alcoholic
solution containing propranolol-1, propranolol-2, and
mecetronium etilsulfate, or
a hand-scrubbing protocol with antiseptic preparation
containing 4% povidone-iodine or 4% chlorhexidine
gluconate.
Outcomes:
Surgical site infection rate:
55/2252 (2.44%) in hand-rubbing protocol
53/2135 (2.48%) in hand-scrubbing protocol
difference 0.04% (95% CI –0.88% to +0.96%)
France
Surgical site infection: full guideline DRAFT (April 2006)
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Cost-effectiveness evidence table (Surgical scrubbing)
Study
Onesko
et al.
1987
Methods
Cost-consequence analysis.
Clinical effectiveness
Before and after study comparing
the effect of soap replacement on
nosocomial infections (including
surgical wound infections).
Outcomes studied: nosocomial
attack rate by species of pathogen
and nosocomial attack rate by
category of infection (including
surgical wound infection).
Population
Patients
admitted to
an acute
care
community
teaching
hospital,
which
included
patients
undergoing
surgery.
Costing
Undertaken prospectively.
Costs included: costs of infections
and of delays in placing MRSA
cases in nursing homes. Costs and
quantities were reported separately.
Larson
et al.
2001
Cost-consequence analysis.
Clinical effectiveness
Before and after crossover trial.
Outcomes studied: 1. Skin condition
as measured by an expert grader
using: a) the Visual Scoring of Skin
(VSS), ranging from 1 (extremely
scaly) to 6 (normal); and b) the
erythema grading scale ranging
from 0 (severe erythema) to 4
(normal).2. Skin condition as
measured by the subject using the
Hand Skin Assessment (HAS) 3.
Full-time
surgical
staff
members
who
performed
an average
of at least
10 scrubs
per week.
Interventions
Intervention
Low-iodine,
health care
personnel
hand wash
(Ido-Kare,
0.05%
complexed
iodinecontaining
soap with skin
conditioners)
Comparator
Non-medicated
liquid natural
hand soap;
and in some
cases
povidone
iodine surgical
soap.
Intervention
Waterless
hand rinse
product
containing
61% ethyl
alcohol wt/wt
1%
chlorohexidine
gluconate
(CHG) and
emollients.
Comparator
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
Surgical wound infections: hand soap 1.04% (19/1833); lowiodine hand wash 0.50% (9/1800) (p<0.025).
The trial also found a reduction in respiratory, urinary tract and
bacteremia infection rates, however, these differences did not
reach significance.
Costing
The authors did not stratify their cost results by category of
infection.
Total annual savings from nosocomial infection reduction were
$109,500; $78,000 due to decreased hospitalisation and
$31,500 due to lack of discharge delays in placing fewer
MRSA cases in nursing homes.
Synthesis of costs and benefits
Not applicable.
Effectiveness
Skin condition using VSS: by day 19 the change from baseline
using the alcohol solution was -0.4 and -1.6 using the
traditional scrub (p<0.002).
Microbial counts were lower postscrub at days five (p=0.002)
and 19 (p=0.02) in the alcohol solution group.
Deficiencies in washing protocol: 50% in traditional scrub,
6.5% in alcohol solution regimen (p=0.001).
Costing
Product & solution cost: traditional scrub $0.38-$0.50,
alcoholic solution $0.40-$0.52.
Average length of washing and drying: traditional scrub 6min,
alcoholic solution 10min.
Conclusions
The authors
concluded that
a low-iodine
hand wash
soap could
result in a
significant
decrease in
nosocomial
attack rates
(including
surgical wound
infections),
resulting also
in considerable
cost savings.
Comments
The study was carried out in
two different time periods so
other external factors could
have explained the reduction
in infection rates. The
authors did not stratify their
cost results by infection
categories. It is therefore not
clear how much of the total
savings are due to surgical
site infections. Furthermore,
the authors failed to include
the costs of the hand
washing.
The authors
concluded that
a protocol for
preoperative
surgical hand
preparation
using a
product
containing
61% ethyl
alcohol and
1% CHG
resulted in
significantly
The authors reported
deviations from protocol,
with both products being
available at some point
during the study. However,
there was no evidence that
deviations from protocol
were more common during
one period than another.
The authors reported
savings of approximately
$40 per hand wash using
the alcohol solution, mainly
being generated through
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Microbial counts in professional’s
hands
4. Number of deficiencies in hand
washing technique
Parienti
et al.
2002
Costing
Undertaken prospectively. Costs
included: staff time, cost of brush
and cost of solution.
Cost-consequence analysis.
Clinical effectiveness
Randomised control trial with 4,387
patients. Outcomes studied:
surgical site infection rates,
compliance rates, and skin
condition as measured with a visual
analogue scale (VAS).
Costing
Undertaken using a previous
French study (Girard et al. 1996)
comparing the costs of the two
techniques for hand and forearm
antisepsis before scheduled
orthopaedic surgery.
Consecutiv
e patients
who
underwent
clean and
cleancontaminate
d surgery.
Traditional
surgical hand
scrub with
detergentbased
antiseptic
containing
4%CHG
Time cost of washing and drying: traditional scrub $60,
alcoholic solution $20.
Total cost of hand wash: traditional scrub $60.50, alcoholic
solution $20.52.
Intervention
Hand rubbing
involving a
75% aqueous
alcoholic
solution (AAS)
containing
propanol-1,
propanol-2 and
mecetronium
etilsulfate.
Effectiveness
Surgical site infections: 2.48% (53/2135) in the hand-scrubbing
protocol; 2.44% (55/2252) in the hand-rubbing protocol, a
difference of 0.04% (95% CI:
-0.88% to 0.96%).
Compliance with the recommended duration of hand washing:
44% hand-rubbing; 28% hand-scrubbing (p=0.008).
Skin condition: skin dryness decreased by 0.9cm after handrub period and increased by 0.4cm after hand-scrub period
(p=0.046); skin irritation decreased by 1.5cm after hand-rub
period but increased by 0.4cm after hand scrub period
(p=0.03).
Comparator
Handscrubbing with
antiseptic
solutions
containing 4%
povidone
iodine or 4%
chlorohexidine
gluconate.
Costing
Cost per week when using povidone iodine or chlorohexidine
gluconate hand scrub was €203, compared with €25 per week
when using AAS.
Surgical site infection: full guideline DRAFT (April 2006)
Synthesis of costs and benefits
Not applicable.
Synthesis of costs and benefits
Not applicable.
greater
reductions in
microbial
counts on
hands,
improved skin
health, and
reduced time
and resources.
The authors
concluded that
given the
equivalence of
hand rubbing
with an
aqueous
alcoholic
solution to
standard hand
scrubbing in
preventing
surgical site
infections,
hand rubbing
with AAS
preceded by a
nonatiseptic
hand wash
was a safe
alternative.
time savings. These
savings, which appear to be
too high, might be explained
by the Hawthorne effect,
with staff scrubbing for more
time than they would have
done have they not
participated in the trial.
The study was a well
conducted RCT, with a large
patient sample. The study
used secondary economic
data from another patient
sample. The authors did not
report the costs included in
this study, hence it is not
possible to determine in
which cost categories were
savings generated
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Study
Cimiotti
et al.
2004
Methods
Cost-consequence analysis.
Clinical effectiveness
Before and after crossover trial.
Outcomes studied: hand hygiene
quality as rated on a 5-point scale
(1 worst to 5 the best in practice) as
rated by two observers.
Costing
Undertaken prospectively. Costs
included: staff time and product
costs.
The mean product cost was
calculated as the product use
multiplied by its cost, and was
reported as per 1,000 patient days.
The overall cost (i.e. product cost +
time cost) was calculated based on
the product cost and nurse time,
and was reported as per 1,000 hand
hygiene episodes.
Population
Staff at a
level III-IV
neonatal
intensive
care unit.
Interventions
Intervention
Waterless
alcohol-based
product (61%
ethyl alcohol)
and a mild
soap hand rub.
Comparator
Detergent
based
antiseptic
containing 2%
chlorhexidine
gluconate
(CHG).
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
A significantly higher mean score on hand hygiene quality was
observed with use of the alcohol-based rub when compared to
the CHG (mean scores: 4.6 and 3.9 out of 5 respectively,
p<0.0001).
Costing
The mean product cost per 1,000 patient days was $1,101 for
the alcohol-based rub compared to $287 for the CHG regimen
(p<0.0001).
The mean overall cost (i.e. product and nurse time) per 1,000
hand hygiene episodes was $147 for the alcohol-based rub
compared to $184 for the CHG regimen (p<0.007).
Conclusions
The authors
concluded that
improving
hand asepsis
through
products which
were more
readily
available, less
expensive, and
resulted in
better skin
integrity of the
nurse, such as
the waterless
alcohol-based
rub, could
result in the
avoidance of
patient
complications
due to surgical
site infection.
Comments
It is unclear what types of
patients were assessed in
the study, although it would
appear that the study
included surgical patients.
The authors reported that
storage of product was
different at both sites. It is
unclear why the authors
reported two sets of results
using a different
denominators (i.e. 1,000
patient days and 1,000 hand
hygiene episodes), and did
not use one, so as to make
comparisons between the
two cost results easier.
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D7: STERILE THEATRE WEAR
Clinical Effectiveness
Study
Participants
Interventions
Outcomes
Aydeniz
200 patients undergoing
gynaecologic laparoscopy
Patients excluded if for
reconstructive tubal surgery
because perioperative antibiotic
prophylaxis would be required.
1. Maximum standard of hygiene (Control) (n=100)
Incidence of infection (erythema, abscess formation, secondary
healing)
1. 5/100 had secondary wound infections
2. 3/100 had secondary wound infections
(1999)
2. reduced standard of hygiene (n=100)
Surgical site infection: full guideline DRAFT (April 2006)
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a) Cost-effectiveness evidence table (Disposable and reusable gowns and drapes)
Study
Moylan et
al. (1987)
Methods
Cost-consequence analysis.
Clinical effectiveness
Before and after study
(n=2,181). Outcomes
studied: rate of
postoperative infection.
Costing
Undertaken prospectively.
Costs included: laundry,
handling, and purchase.
Costs and quantities were
not reported separately.
Muller et
al. (1989)
(Abstract)
Cost-consequence analysis.
Clinical effectiveness
Prospective cohort study
(n=1,033). Outcomes
studied: rate of
postoperative infection and
operating staff preferences.
Population
Patients
undergoing
clean or
cleancontaminated
general
surgical
procedures
performed at
a community,
university
and
metropolitan
hospital.
Interventions
1) Disposable
gown and drape
material made of
spun-bounded
fibres
Patients
undergoing
surgery.
1) Disposable
gown and drape
system.
2) Re-usable cotton
gown and drape
Results
Effectiveness
Post-operative infection rate: reusable group 6.51%
(73/1121), disposable group 2.83% (30/1060,
p=0.0001)
Costing
Cost per operation:
Community hospital: disposable $25.78, reusable
$28.14
University hospital: disposable $30.41, reusable $48.56
Metropolitan hospital: disposable $15.30, reusable
$18.63
Conclusions
The authors
concluded
that the
impact of the
disposable
system was
significant in
both
reducing
wound
infections
and affecting
cost savings.
Synthesis of costs and benefits
Not undertaken.
2) Conventional
reusable cotton
gowns and drapes
Costing
Undertaken prospectively.
Costs included: unclear.
Costs and quantities were
not reported separately
Effectiveness
The authors reported the use of disposable gown and
drape material reduced the postoperative wound
infection rate.
Conclusions
not in
abstract.
Comments
The study was
undertaken in different
time periods, which
could have biased the
authors’ results. The
authors performed
regressions in order to
control for biases such
as wound category,
hospital type, length of
surgery, age, sex etc…
Although the costing
exercise was thorough
and included major cost
categories, the authors
did not included
disposal costs.
From the abstract it is
not possible to make
any further comments
on the paper.
With respect to ease of handling and wear the
disposable material was preferred by the operatingstaff, both doctors and nurses.
Costing
Over a 12-month period there was a reduction of 7.5%
in costs when the disposable gown and drape system
was used.
Synthesis of costs and benefits
Not undertaken.
Surgical site infection: full guideline DRAFT (April 2006)
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b) Cost evidence table (Disposable and reusable gowns)
Study
DiGiacomo
et al
(1992)
McDowell
(1993)
Methods
Costing study.
Costing
The authors compared the
costs incurred by the
operating rooms of two
hospitals, one of which only
used disposable operating
room apparel, and the other
one only employing
reusable scrub suits and
gowns. Costs included:
purchase, laundry,
sterilisation and disposal.
Costing study
Costing
Undertaken using data from
the literature, a survey of 30
American hospitals and
manufacturers’ reports.
Costs included: initial
purchase, of replacements,
laundering, inspecting,
repairing, ironing, folding,
sterilising, disposal, storage,
and labour costs. Costs and
quantities were not reported
separately.
Population
Patients
undergoing
surgery.
Interventions
Intervention
Disposable
scrub suits and
gowns.
Comparator
Reusable
scrub suits and
gowns.
Patients
undergoing
abdominal
surgery.
Gowns made
from one of the
following
materials:
1) FABRIC 450
(disposable)
2) Standard
linen
(reusable)
Results
Although the hospital using reusable gown and scrub
suits performed more operations per year than the
hospital using disposable clothing (9,657 vs. 5,927,
respectively), it incurred less clothing costs, $35,680,
than the hospital using disposable clothing ($155,664).
Per operation the total cost of using reusable gowns
was $0.68 per gown per case, compared to $2.45 for
the disposable gowns.
Cost of gowns per average abdominal operation:
FABRIC 450: $11.11
Standard linen: $4.45 to $10.78 depending on number
of reuses and laundering costs
Compel: $8.97 to $10.82 depending on laundering
costs
The analysis also showed that neither the disposable
nor the reusable products were clearly superior from
an environmental standpoint.
Conclusions
The authors
concluded
that hospitals
should reevaluate their
use of
disposable
room attire to
reduce
operating
costs and the
amount of
medical
waste
generated.
Standard
linen gown
costs were
less than
either the
single-use or
ComPel
gowns.
Comments
The authors included the
costs of scrub suits, which
would skew the results in
favour of reusables.
However, omitting such
clothing from the analysis
did not affect the authors’
conclusions. The study
was undertaken in two
different hospitals, each
using one particular gown.
Therefore differences in
costs between the two
hospitals, and hence
clothing types, could be
affected by external
factors as the study
settings were different.
The study was
commissioned by
Johnson & Johnson, the
company supplying
ComPel. However, this
would not appear to have
influenced the findings of
the report as ComPel was
not found to be any better
than the other gowns in
terms of cost and impact
on the environment.
3) ComPel
(reusable)
Surgical site infection: full guideline DRAFT (April 2006)
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D8: DOUBLE GLOVING TO REDUCE SURGICAL CROSS-INFECTION
Clinical Effectiveness
Study
Sanders
1990
Sebold
1993
Participants
Surgeons. Orthopaedic surgery
involving the manipulation of
bone or application of implants.
Sample size: 58 double inner
gloves and 52 cloth/latex inner
gloves
Primary surgeon. Orthopaedic
surgery - total joint
replacements. Sample size: 58
double outer gloves and 63
latex/liner outer gloves.
Interventions
Double latex versus latex inner with cloth outer glove.
Outcomes
Primary:
Glove perforation numbers
Secondary:
SSI rates
Double latex versus latex inner with orthopaedic outer versus
double latex with cloth liner insert
Primary:
Glove perforation numbers
Secondary:
SSI rates
Surgical site infection: full guideline DRAFT (April 2006)
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D9: FACE MASKS FOR THE PREVENTION OF SURGICAL SITE INFECTION
Clinical Effectiveness
Study
Participants
Interventions
Outcomes
Chamberlain
1984
41 female patients undergoing
surgery. 24 clean and 17 non-clean.
Inclusion criteria; gynaecology.
Exclusion criteria; none stated. Trial
setting; operating department.
Baseline comparability; none
reported.
3088 patients undergoing general,
vascular, breast, acute and cold
surgery. Clean surgery was
performed on 1429. Non-clean
surgery was performed on 1659.
Inclusion criteria; operation through
intact skin and primary closure.
Exclusion criteria; patients not
informed or consent not given,
outpatients, orthopaedics, urology,
anal surgery, insertion of synthetic
grafts, or haematologic disease. Trial
setting; operating department.
Baseline comparability; similar for
age, acute and cold surgery.
N=24
1. Mask (clean surgery ) (n=14) vs
2. No Mask (clean surgery ) (n=10)
Wound infection defined as serious enough to warrant antibiotics
in two of the cases and via a high vaginal swab in the third case.
1. 0/14 cases had wound infections.
2. 3/10 cases had wound infections.
Tunevall
1991
N=17 Clean contaminated surgery, excluded from
analysis as this was vaginal surgery
1. Mask (clean surgery) (n=706)
2. No Mask (clean surgery) (n=723)
3. Mask (contaminated -dirty surgery) (n=831)
4. No Mask (contaminated-dirty surgery) (n=828)
Surgical site infection: full guideline DRAFT (April 2006)
Wound infection defined as visible pus and /or cellulitis without
pus requiring debridement, drainage and/ or antibiotics.
1. 13/706 had wound infections.
2. 10/723 had wound infections.
3. 60/831 had wound infections.
4. 45/828 had wound infections
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D10: PREOPERATIVE SKIN ANTISEPTICS FOR PREVENTING SURGICAL WOUND INFECTION
Clinical effectiveness
Study
Alexander
1985
USA
Participants
480 patients undergoing elective
surgery.
234 clean surgery
246 non clean surgery
Inclusion: ability to apply incise
drape and informed consent
Exclusion: allergy to Iodine, dirty
wounds and areas difficult to
drape (perineal, genitalia, feet,
upper extremities, head and
neck)
Baseline comparability: sex,
surgical service, attending
surgeon, resident, type of
operation, wound classification,
prophylactic antibiotics, hair
removal, antibiotic irrigation and
suction catheters.
Interventions
Interventions:
a) One minute scrub 70% alcohol and polyester antimicrobial
drape (n = 147)
b) One minute scrub 2% Iodine in 90% alcohol and iodophor
antimicrobial incise drape (n = 164)
c) 10 minute scrub Povidone-iodine (Betadine) soap, 2
applications of povidone-iodine (Betadine) paint and cloth drape
(n = 169)
Outcomes
Outcomes
Discharge of pus, with or without positive culture, assessed at 30
days post operatively.
Clean surgery:
1. 1/76
2. 1/81
3. 1/77
All three infections were ‘superficial’
Clean-contaminated surgery:
1. 2/60
2. 3/72
3. 2/83
Contaminated surgery:
1. 0/11
2. 1/11
3. 0/9
Total:
1. 3/147
2. 5/164
3/169
Surgical site infection: full guideline DRAFT (April 2006)
Page 415 of 599
DRAFT FOR CONSULTATION
Study
Participants
Alexander
1985_2
115 patients
USA
Interventions
1.
1 min scrub with 70% alcohol + iodophor polyester
incise drape
Inclusion: ability to apply incise
2.
1 min scrub with chlorhexidine in alcohol (Hibitane) +
drape and informed consent
iodophor drape as above
Exclusion: allergy to Iodine, dirty
3.
1 min scrub with 2% iodine in 50% alcohol + iodophor
wounds and areas difficult to drape drape as above
(perineal, genitalia, feet, upper
4.
1 min scrub with 2% iodine in 70% alcohol + iodophor
extremities, head and neck)
drape as above
Baseline comparability: not stated
5.
1 min scrub with 2% iodine in 90% alcohol + iodophor
drape as above
Berry (1982) 866 patients
UK
371 clean operations
495 non clean operations
Inclusion: all elective cases
Exclusion: sensitivity to solutions
Baseline comparability: age, sex
and type of operation.
Interventions
Povidone-iodine 10% in alcohol
Chlorhexidine 0.5% in spirit (Hibitane)
Brown 1984
1. 0.5% Chlorhexidine spray in 70% alcohol
2. Scrub (6 min) with iodine soap (0.5% iodine) and aqueous
povidone-iodine paint
USA
737 patients
239 obstetric
273 gynaecologic
225 general surgery
Exclusion: did not meet surgical
procedure category
Baseline comparability: age,
diagnosis, type of procedure,
presence of major risk factors
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes and results
Outcomes:
Incidence of infection:
1.
2/45
2.
1/28
3.
0/17
4.
0/12
5.
1/13
Outcomes
Wounds classified as normal, erythematous, oedematous,
discharging, purulent. Independently assessed by 2 members of
the team.
1. 28/176
2. 8/195
These included ‘other clean surgery’ and biliary tract.
Bowel surgery:
1.
3/33; 2.
5/28
Other laparotomy:
1.
9/47; 2. 15/49
Hernia/genitalia/veins:
1.
21/157; 2. 16/181
All surgery:
1.
61/413; 2. 44/453
Outcomes:
Minor wound infection classified as superficial separation (less
than 1 cm)
Major infection with separation of greater than one third of
incision site
or evidence of purulent exudate or abscess
Minor infection:
1. 23/378; 2. 29/359
Major infection
1. 11/378; 2. 6/359
Page 416 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes and results
Ellenhorn
2005
Inclusion: 234 patients
undergoing non-laparoscopic
abdominal operations
Exclusion: active infection,
neutropenia, allergy, anticipated
insertion of prosthetic material
A: 5-minute scrub with povidone-iodine soap, absorption with
sterile towel, aqueous povidone-iodine paint (n=115)
B: povidone-iodine paint only (n=119)
Wound infection (erythema or purulence requiring intervention):
A: 12 (10%)
B: 12 (10%)
10% povidone iodine solution (Betadine)
Alcohol 70%
Iodine tincture 2%
Wound healing was classified as a) primary and b) complicated
wound healing which included erythema, oedema, haematoma,
seroma, or the formation of a wound abscess.
Interventions
1. 5 minute Iodophor scrub /
application iodophor solution /
dried with cloth
2. 1 minute scrub 70% isopropyl
alcohol / iodophor impregnated incise drape.
1. 24/102
2. 23/118
Outcomes
Temp >38degC on 2 occasions at least 24 hours post operative.
Endomyometritis - uterine tenderness, no other infections noted.
Wound infection - temperature, erythema, tenderness,
separation of wound edges, no uterine tenderness, malodorous
or discoloured lochia. No indication of who assessed wounds.
1. 2 / 41
2. 3 / 38
Kothuis
1981
Baseline comparability: Yes
Loss to follow-up: Not stated
220 patients undergoing an
elective laparotomy
Baseline comparability: sex, age
The
Netherlands
Lorenz
1988)
USA
79 obstetric patients
All clean surgery
Inclusion: all women undergoing
Caesarean sections between June
1983 to April 1984, who gave
informed consent
Exclusion: allergy to iodine, <18
years, diagnosis of
chorioamnionitis, emergency
situations that prevented informed
consent or when culture plates
were not available.
Surgical site infection: full guideline DRAFT (April 2006)
Page 417 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes and results
Roberts
1995)
200 adult patients
All clean surgery
Inclusion: consecutive consenting
patients
Exclusion: allergy to iodine
Baseline comparability: no
difference for age, diabetes,
vascular disease or post operative
variables, although sex of patients
not stated
209 adult patients
All clean surgery
Inclusion: CABG, one or more high
risk predictive factor
Exclusion: pre-existing infection,
allergy to iodine, CPR in progress
Baseline comparability: age, type
of surgery
Interventions
1. Iodophor-in-alcohol, film forming, water insoluble antiseptic
(mean application time 4 minutes)
2. Aqueous Iodophor scrub (5 to 10 minutes) and paint (control)
Iodophor impregnated incise drape on
all chest wounds but not leg wounds.
Outcomes
CDC guidelines - wound appearance, drainage and cultured organisms.
Purulent material drained, not necessarily positive culture. Superficial
infection being skin, subcutaneous tissue and muscle above fascial
layer.
Deep infection being below fascial layer. See at 2 weeks post
operatively and telephoned at 30 days.
USA
Segal
2002
USA
1. 10/104
2. 9/96
Interventions
1. Povidone-iodine paint
2. Povidone-iodine five minute scrub then paint
3. One-step iodophor/alcohol water insoluble film
4. One-step iodophor/alcohol water insoluble film with iodine
impregnated incise drape
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Drainage, redness, tenderness, or sternal instability
1. 7/49
2. 7/45
3. 1/49
4. 3/48
Page 418 of 599
DRAFT FOR CONSULTATION
Cost-effectiveness (Antiseptics)
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Hagen et
al. 1995
Cost minimisation analysis.
Clinical effectiveness
Retrospective chart review.
Outcomes studied: surgical site
infection rates, and acute surgical
site inflammatory (ASSI) response
rates.
Nonemergent
CABG
surgery
patients
where their
surgical
sides were
classified
as clean
wounds.
Intervention
Isopropyl alcohol
preparation / idoophorimpregnated adhesive
drape, whereby
povidone iodine is
incorporated directly
into adhesive polymer
which release a
microbicide to the skin
(n=32).
Effectiveness
SSI rates:
Intervention: 0/32 (p=0.549)
Comparator: 1/39 (3.3%)
SSI + ASSI (acute surgical site inflammatory)
response rates:
Intervention: 3/32 (9.4%)
Comparator: 3/39 (7.7%)
The authors
concluded the
intervention was
equally effective
as the
comparator, but
more costeffective.
Small sample size,
making it difficult to
identify statistically
significant differences.
Based on a retrospective
study design, limited in
value by the potential for
incomplete
documentation. Different
drapes were applied after
skin preparation, making
it more difficult to
determine which type of
skin preparation
antiseptic is more costeffective by itself.
The authors
concluded that the
antiseptic skin
preparation
DuraPrep solution
was not different
from the PVPI
skin preparation.
However, the
authors also
concluded that
there was a
reduction in time
and cost when DP
was used.
The costing analysis was
restricted to only 20
patients in the DP and 22
patients in the PVPI
group. It is unclear if
there were any significant
differences between
these patients and the
rest of patients included
in the effectiveness
analysis. The patient
sample required for the
effectiveness study was
reached, and patient
groups were shown to be
comparable. Statistical
analysis of costs and
outcomes were
performed appropriately.
Costing
Undertaken retrospectively. Costs
included: cost of product and time
costs (the time required for
operating room personnel to
complete preoperative skin
preparation).
Price year not reported.
Jacobson
et al.
2005
Cost-minimisation analysis.
Clinical effectiveness
Randomised controlled trial
(n=179). Outcomes studied: wound
contamination (i.e. wound culture
growth), drape lift, time to prepare
patient, and adverse reactions.
Costing
Undertaken prospectively. Costs
included: time costs to prepare
patient and cost of preparation
materials. The price year was
2001-2002.
Comparator
Iodophor scrub & paint
preparation / plain
adhesive drapes
(n=39).
Patients
undergoing
primary or
revision
total hip or
knee
arthroplasty
who were
18 years or
older.
Surgical site infection: full guideline DRAFT (April 2006)
Costing
Intervention: $114.7 per patient
Comparator: $148.7 per patient
Synthesis of costs & benefits
Not relevant.
Effectiveness
Contaminated wounds:
Intervention: 28.0%
Comparator: 36.4%.
95% CI in difference: -22.4% to 5.6%
Edge lift of drape (cm):
Intervention: 2.5+/-4.22
Comparator: 6.9+/-7.03 (p<0.0001)
Time to prepare patients (min):
Intervention: 3.5+/-0.91
Comparator: 9.7+/-1.44 (p<0.0001).
Costing
Intervention: $93.36+/-23.27 per patient
Comparator: $248.91+/-34.99 per patient
p<0.0001).
Synthesis of costs & benefits: Not relevant.
Page 419 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Lorenz
et al. 1988
Cost-minimisation analysis.
Clinical effectiveness
Randomised controlled trial (n=79).
Outcomes studied: skin colony
counts and infectious morbidity.
Women
undergoing
caesarean
section.
Intervention
One-minute circular
scrub done with 70%
isopropyl alcohol
followed by application
of an iodophorimpregnated adhesive
film (n=38)
Effectiveness
Difference between preoperative and postoperative mean log colony counts:
Intervention: -1.16+/-0.92
Comparator: -1.23+/-0.95 (p=0.70)
Infectious morbidity was not significantly
different in the two groups: endomyometritis
(n=3 in the intervention group, 2 in the control
group).
No other infectious morbidity was observed.
The authors
concluded that the
study
demonstrated the
antimicrobial
effectiveness of a
new, more rapid
method of preoperative skin
preparation before
caesarean section
as compared to a
longer, traditional
method.
Small sample size,
making it difficult to
identify statistically
significant differences.
Different drapes were
applied after skin
preparation, making it
more difficult to
determine which type of
skin preparation
antiseptic is more costeffective by itself.
Costing
Undertaken prospectively.
Costs included: cost of product and
time costs (the time required for
operating room personnel to
complete preoperative skin
preparation).
Price year not reported.
Comparator
Standard, five minute
iodophor scrub
followed by application
of iodophor solution,
with the patient being
draped in cloth (n=41)
Surgical site infection: full guideline DRAFT (April 2006)
Costing
Intervention: $10.43 per patient
Comparator: $20.80 per patient
Synthesis of costs & benefits
Not relevant.
Page 420 of 599
DRAFT FOR CONSULTATION
D11: DRAPES FOR THE PREVENTION OF SURGICAL SITE INFECTION
Clinical Effectiveness
Study
Alexander
1985_3
Participants
577 patients
322 clean operations
255 clean contaminated and
contaminated
Interventions
Interventions
1. Cloth drape + iodine prep*
2. Ethylene methacrylate incise drape (Steri-drape 2) +
iodine prep*
• 5-10 min scrub with iodophor soap (Betadine) then
paint twice with
iodophor (Betadine)
Outcomes
Outcomes
Incidence of infection:
1. 4/267
2. 8/310
Clean: 1. 3/144; 2. 2/178
Clean-contaminated / contaminated: 1. 1/123; 2. 6/132
Bellchambers
1999
464 patients
All clean surgery
Inclusion: Isolated coronary artery
surgery
Exclusion: No details
Baseline comparability: Age, sex,
other demographic, diabetes more
prevalent in paper drape group
1. Disposable, paper drape including iodophor
impregnated adhesive drape
2. Re-usable fabric drape including iodophor adhesive
drape
Chiu 1993
125 hip fracture operations
Baseline comparability: sex, age,
number of preoperative admission
days, types and length of surgery
The operation site was prepared with povidone solution
and then draped with sterile towels and then randomised
to
the following groups:
Adhesive plastic drape (opsite)
No drape
Leg and sternal wounds were assessed using ASEPSIS
system and a score of more than 20 was categorised as
infected.
Leg infection:
1. 27/234
2. 31/216
Sternal infection
1. 13/250
2. 12/236
Outcomes:
Infections classified as ‘superficial’ or ‘deep’ based on
clinical observation
and swab culture. No details given of assessment criteria.
6/65
5/55
USA
Surgical site infection: full guideline DRAFT (April 2006)
Page 421 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes
Dewan 1987
NZ
1016 patients
365 clean surgery
651 non clean surgery
Inclusion: all patients
Exclusion: patients under 10 years
old, when drapes precluded optimum
incision placement or iodine allergy.
Baseline Comparability: for major risk
factors
Interventions
1. Iodophor impregnated incise drape (3M Ioban)
2. No drape (control)
Outcomes
Erythema more than 1 cm lateral to wound margin, 1/3
length, discharging pus or fluid with a positive culture
(inflammation around suture sites ignored). Infection control
nurse assessed wounds at 3 to 4 days, 8 to
10 days and 3 weeks post operatively.
Lorenz 1988
USA
79 obstetric patients
All clean surgery
Inclusion: all women undergoing
Caesarean sections between June
1983 to April 1984, who gave
informed consent
Exclusion: allergy to iodine, <18
years, diagnosis of chorioamnionitis,
emergency situations that prevented
informed consent or when culture
plates were not available.
Skin preparation for both groups - Iodophor antiseptic
(aq) then alcohol.
Interventions
1. 5 minute Iodophor scrub /
application iodophor solution /
dried with cloth
2. 1 minute scrub 70% isopropyl
alcohol / iodophor impregnated incise drape.
Surgical site infection: full guideline DRAFT (April 2006)
Inguinal hernia, biliary and vascular
1.
9/190; 2.
5/175
Clean-contaminated
1.
11/173; 2. 10/144
Contaminated
1.
5/70;
2. 5/63
Dirty
1.
8/67;
2.
9/66
All surgery
1.
36/529; 2.
34/483
Outcomes
Temp >38degC on 2 occasions at least 24 hours post
operative. Endomyometritis - uterine tenderness, no other
infections noted.
Wound infection - temperature, erythema, tenderness,
separation of wound edges, no uterine tenderness,
malodorous or discoloured lochia. No indication of who
assessed wounds.
1. 2 / 41
2. 3 / 38
Page 422 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes
Roberts 1995
200 adult patients
All clean surgery
Inclusion: consecutive consenting
patients
Exclusion: allergy to iodine
Baseline comparability: no difference
for age, diabetes, vascular disease or
post operative variables, although sex
of patients not stated
Interventions
1. Iodophor-in-alcohol, film forming, water insoluble
antiseptic (mean application time 4 minutes)
2. Aqueous Iodophor scrub (5 to 10 minutes) and paint
(control)
Iodophor impregnated incise drape on
all chest wounds but not leg wounds.
Outcomes
CDC guidelines - wound appearance, drainage and cultured
organisms. Purulent material drained, not necessarily positive
culture. Superficial infection being skin, subcutaneous tissue and
muscle above fascial layer.
Deep infection being below fascial layer. See at 2 weeks post
operatively and telephoned at 30 days.
209 adult patients
All clean surgery
Inclusion: CABG, one or more high
risk predictive factor
Exclusion: pre-existing infection,
allergy to iodine, CPR in progress
Baseline comparability: age, type of
surgery
603 caesarian patients
Inclusion: Consecutive consenting
patients undergoing caesarian
section
Exclusion: clinically suspected
rupture of uterus
Baseline comparability: Operative
features were similar in both groups
for status of surgery, incision site,
skin-to-skin surgical time, and sklin
closure method, percentage of
elective surgery, duration of
membrane rupture and wound group
classification. There were slightly
older patients in the intervention
group and greater parity
Interventions
5. Povidone-iodine paint
6. Povidone-iodine five minute scrub then paint
7. One-step iodophor/alcohol water insoluble film
8. One-step iodophor/alcohol water insoluble film with
iodine impregnated incise drape
Outcomes
Drainage, redness, tenderness, or sternal instability
1. 7/49
2. 7/45
3. 1/49
4. 3/48
1. INCISE adhesive drape
2. Standard draping practice
Wounds were assessed on days 2,3,4 and 5
Infection was diagnosed if two of three features were
present:
1. Erythematous cellulitis
2. Seropurulent discharge
3. Positive swab culture
Assessors blinded to intervention
1. 34/ 305
2. 30/ 298
USA
Segal 2002
USA
Ward 2001
1. 10/104
2. 9/96
Surgical site infection: full guideline DRAFT (April 2006)
Page 423 of 599
DRAFT FOR CONSULTATION
a) Cost-effectiveness evidence table (Disposable and reusable gowns and drapes)
Study
Moylan et
al. (1987)
Methods
Cost-consequence analysis.
Clinical effectiveness
Before and after study
(n=2,181). Outcomes
studied: rate of
postoperative infection.
Costing
Undertaken prospectively.
Costs included: laundry,
handling, and purchase.
Costs and quantities were
not reported separately.
Muller et
al. (1989)
(Abstract)
Cost-consequence analysis.
Clinical effectiveness
Prospective cohort study
(n=1,033). Outcomes
studied: rate of
postoperative infection and
operating staff preferences.
Population
Patients
undergoing
clean or
cleancontaminated
general
surgical
procedures
performed at
a community,
university
and
metropolitan
hospital.
Interventions
1) Disposable
gown and drape
material made of
spun-bounded
fibres
Patients
undergoing
surgery.
1) Disposable
gown and drape
system.
2) Re-usable cotton
gown and drape
Results
Effectiveness
Post-operative infection rate: reusable group 6.51%
(73/1121), disposable group 2.83% (30/1060,
p=0.0001)
Costing
Cost per operation:
Community hospital: disposable $25.78, reusable
$28.14
University hospital: disposable $30.41, reusable $48.56
Metropolitan hospital: disposable $15.30, reusable
$18.63
Conclusions
The authors
concluded
that the
impact of the
disposable
system was
significant in
both
reducing
wound
infections
and affecting
cost savings.
Synthesis of costs and benefits
Not undertaken.
2) Conventional
reusable cotton
gowns and drapes
Costing
Undertaken prospectively.
Costs included: unclear.
Costs and quantities were
not reported separately
Effectiveness
The authors reported the use of disposable gown and
drape material reduced the postoperative wound
infection rate.
Conclusions
not in
abstract.
Comments
The study was
undertaken in different
time periods, which
could have biased the
authors’ results. The
authors performed
regressions in order to
control for biases such
as wound category,
hospital type, length of
surgery, age, sex etc…
Although the costing
exercise was thorough
and included major cost
categories, the authors
did not included
disposal costs.
From the abstract it is
not possible to make
any further comments
on the paper.
With respect to ease of handling and wear the
disposable material was preferred by the operatingstaff, both doctors and nurses.
Costing
Over a 12-month period there was a reduction of 7.5%
in costs when the disposable gown and drape system
was used.
Synthesis of costs and benefits
Not undertaken.
Surgical site infection: full guideline DRAFT (April 2006)
Page 424 of 599
DRAFT FOR CONSULTATION
b) Cost evidence table (Disposable and reusable drapes)
Study
Anon
(1979)
Methods
Costing study.
Costing
Estimation of costs based on
1,000 surgical cases per
month. Costs included: labour,
laundry, sterilisation, linen and
equipment replacement and
purchase costs.
Davis
(1969)
Costing study.
Costing
Undertaken prospectively.
Costs included: purchase,
sewing and repairing drapes,
labour costs of laundering and
the costs of assembling
surgical packs.
Population
Patients
undergoing
surgery in a
1,200 bed
University
hospital.
Interventions
Intervention
Disposable
drapes
Patients
undergoing
surgery.
Intervention
Disposable
drapes
Results
The authors estimated potential savings of $100,000
per year, equivalent to $8.35 per surgical procedure.
Comparator
Reusable linen
drapes
Comparator
Reusable muslin
linen drapes
Surgical site infection: full guideline DRAFT (April 2006)
The authors reported that savings could be achieved in
labour costs in packing, sewing and laundry.
Overall cost comparison of the two systems resulted in
estimates of savings of $556.81 per month with
conversion to disposable drapes.
The authors also reported that the disposable draping
system required less storage space, and saved 6,000
pounds of laundry per month at a cost of seven cents
per pound.
Conclusions
The report
concluded
that even
considering
some of the
start up costs
involved with
the use of
disposable
drapes,
substantial
savings were
achieved.
The authors
concluded
that
conversion to
a disposable
draping
system
resulted in
savings to the
hospital.
Comments
As in the study above,
the results of this study
may no longer be
applicable to current
practice. The authors
failed to report costs by
resource category, and
did not report were the
estimated savings were
accrued from.
The study was
published over 35 years
ago, hence its
relevance may no
longer be applicable
due to advances in
draping materials. The
authors also failed to
report costs by resource
category, although they
did report the
categories where
savings were made.
Page 425 of 599
DRAFT FOR CONSULTATION
Study
McDowell
(1993)
Methods
Costing study
Costing
Undertaken using data from
the literature, a survey of 30
American hospitals and
manufacturers’ reports. Costs
included: initial purchase, of
replacements, laundering,
inspecting, repairing, ironing,
folding, sterilising, disposal,
storage, and labour costs
associated with initial draping
of the patient and additional
draping during the operation.
Costs and quantities were not
reported separately.
Murphy
(1993)
Costing study.
Costing
The analysis included drape
fabrics meeting infection
control standards for OR linen;
possible future trends in
draping practice; number of
drapes required for each
procedure; costs, including
one-time and ongoing; laundry
staff requirements and
processing costs; sterilisation
needs and hospital
capabilities; costs of handling,
storing and removing the linen;
space requirements for pack
make-up; and environmental
impact.
Population
Patients
undergoing
abdominal
surgery.
Interventions
Drapes made
from one of the
following
materials:
1) FABRIC 450
(disposable)
2) Standard linen
(reusable)
Results
Cost of drapes per average additional operation:
FABRIC 450: $16.51 to $24.15 depending on number
of drapes required per operation
Standard linen: $$14.39 to $22.70 depending on
number of drapes required per operation
Compel: $16.25 to $23.37 depending on number of
drapes required per operation
The analysis also showed that neither the disposable
nor the reusable products were clearly superior from an
environmental standpoint.
3) ComPel
(reusable)
The study
was done on
the
operating
room,
including
inpatient and
same day
surgery
drape
usage.
Intervention
Reusable drapes
(ComPel,
Standard Textile
and Rotecno,
Rotecno AG).
ComPel barrier
fabric had an
estimated
product life of 75100 uses.
Rotecno had a
product life of
200 uses.
Comparator
Disposable
drapes.
Surgical site infection: full guideline DRAFT (April 2006)
Cost of disposable drapes:
$594,063 per year
Cost of reusable drapes:
Year 1, $814,126
Year 2, $743,386
Year 3, $743,386
Conclusions
The author of
the report
concluded
that
economically,
there was
little or no
cost
difference
between
single use
and reusable
surgical
drapes.
Comments
The study was
commissioned by
Johnson & Johnson, the
company supplying
ComPel. However, this
would not appear to
have influenced the
findings of the report as
ComPel was not found
to be any better than
the other gowns in
terms of cost and
impact on the
environment.
The author
concluded
that reusable
surgical
drapes were
a viable
alternative
from an
environmental
perspective
but based on
the
information,
the author did
not consider
them to be
financially
competitive.
Relevant costs such as
those to send
disposable drape refuse
to the landfill site, or the
increase in charges for
electricity waste or
additional loads going
into sewage treatment if
using reusable drapes
were not included in the
study.
Page 426 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
NHS
(1994)
Cost analysis.
Patients
undergoing
surgery in an
NHS trust
Intervention
New single-use
drape
(Kilinidrape)
The annual cost of the reusable linen drapes was
found to be £65,882, or $5.92 per operation.
The report
concluded
that that
Kilinidrape be
used as it
was a costeffective
system, which
would run
itself,
releasing
nursing time
for direct
patient care.
The report did not
mention the resource
categories included
when estimating the
costs of the disposable
drapes.
Costing
Estimation of costs based on
11,116 draped procedures in
an English hospital.
The categories included to
estimate the costs of reusable
drapes were: laundry of linen,
repairs, purchase,
replacement, and sterilisation
costs. It is unclear which
categories were included to
estimate the costs of
disposable drapes
Comparator
Reusable linen
drapes
Surgical site infection: full guideline DRAFT (April 2006)
The annual cost of the disposable drapes (Kilinidrape)
was found to be £66,584.84, or £5.99 per operation.
Page 427 of 599
DRAFT FOR CONSULTATION
D12: PERIOPERATIVE WARMING
Clinical Effectiveness
Study
Kurz 1996
RCT
Country:
Austria
Funding:
public grants
and
Augustine
Medical Ltd.
Participants
Interventions
Outcomes / results
200 participants
2 groups (gr1: 104; gr2: 96)
Exclusion criteria: minor colon
surgery, immunosuppressive
drugs, recent history of
infection, malnutrition
Mean age 60 y (range 18-80),
50% male, 30% smokers
Group 1: normothermia NT (intervention) – core
temperatures maintained near 36.5°C
Definition of infection: presence of pus and a positive culture
Outcomes and tools: risk of infection measured by SENIC and
NNISS scores; wound infections as per definition and also by
ASEPSIS score (wound infection and wound healing); comfort
and pain - VAS
Follow up: assessed daily and two weeks after surgery
Assessment by: Surgeon determined when to begin feeding,
remove sutures, and discharge pts from hospital; physicians
assessed the wound daily in the hospital and then two weeks
after surgery
Antibiotics given: during induction of anaesthesia cefamandole
and metronidazole started and continued for about 4 days postoperatively
Type of surgery: elective
colorectal resection for cancer
(90%) or inflammatory bowel
disease
Degree of contamination: clean
contaminated
Group 2: hypothermia HT (routine intra-operative thermal
care) – core temperature allowed to decrease to approx
34.5°C
Description of procedure:
All patients were hydrated aggressively during operation,
fluids administered through a fluid warmer, which was
activated only in the normothermia group. Forced-air
cover was positioned over the upper body of every
patients but was set to deliver air at ambient temperature
in the hypothermia group and at 40°C in the
normothermia group. The temperature was not controlled
post-operatively; surgeons, physicians and pts were not
aware of pts’ group assignment.
Results: (means ± SD)
Core temperatures:
1 NT: 36.6 ±0.5°C; 2 HT: 34.7 ±0.6°C
p<0.001
Infection:
Overall incidence of wound infections was 12%
1 NT: 6 of 104 (6%); 2 HT: 18 of 96 (19%)
p=0.009
ASEPSIS scores:
1 NT: 7±10 2 HT: 13 ± 16
p=0.002
Wound healing:
4 pts in NT and 7 in HT required admission to intensive care unit
(wound dehiscence, colon perforation, peritonitis)
significantly more collagen deposited near the wound in NT
group then HT (assessed in a subgroup of pts)
Length of hospital stay:
1 NT: 12.1±4.4 days ; 2 HT: 14.7±6.5 days
Surgical site infection: full guideline DRAFT (April 2006)
p=0.003
Page 428 of 599
DRAFT FOR CONSULTATION
Mortality: 2 pts in each group during the month after surgery
Melling
2001
RCT
Country: UK
Funding:
grants from
Action
Research
and Smith
&Nephew;
Augustine
Medical Inc.
– provision
of
consumables
421 participants (416
completed)
3 groups (Gr 1: 139; Gr 2: 138,
Gr 3: 139)
Exclusion criteria: less than 18y,
pregnant, RT or chemotherapy,
infection, oral steroid treatment
Mean age 50 ± 14 y , 55-64%
male
Type of surgery: short duration
elective breast surgery (about
40%) hernia repair (about 30%),
varicose vein surgery (about
30%)
Degree of contamination: clean
Incision length: scar no longer
than 3 cm
Co-morbidities: cancer
diagnosis (30%), previous
surgery in the last 3 months
Group 1: standard treatments (no warming)
Group 2: local pre-op warming
Group 3: systemic pre-op warming
Description of procedure: All patients received same
standard preoperative care. Patients in Group 2 received
a minimum of 30 min pre-op warming of planned wound
area using a non-contact radiant heat dressing.
Patients in Group 3 received 30 min of pre-op warming of
the whole body using a forced-air warming blanket.
Both warming devices were left in situ until just before
surgery
Pain: virtually identical in both groups
Patient thermal comfort: ss greater in the NT group than in the
HT group during 3 hours after surgery
Other adverse events:
Proportion of infections and length of hospital stay was ss higher
among smokers
Definition of infection: presence of purulent discharge or a
painful erythema that lasted for 5 days and was treated with
antibiotics within 6 weeks of surgery
Outcomes and tools: wound infections as per definition and also
scored using ASEPSIS wound scoring system
Follow up: at 2 and 6 weeks after surgery
Assessment by: single trained observer (blinded to the
treatment)
Antibiotics given to: Gr 1: 34%; Gr 2: 26%, Gr 3: 26% ; ss more
in Gr 1 than in Gr 2+3 (p=0.002)
Results: (means ± SD)
Initial core temperatures ss increased in warming groups, but
within normal limits after surgery (36.41± 0.59°C)
Infection:
Overall incidence of wound infections was 8 %.
Gr 1: 19 of 139 (14 %)
Gr 2: 5 of 138 (4 %) p=0.003
Gr 3: 8 of 139 (6%) p=0.026
There was a lower rate of infections in the combined warming
group when compared with a group without warming (p=0.001)
ASEPSIS scores:
ss lower (p=0.007) in the combined warmed group when
compared with the non-warmed group
Length of hospital stay: not evaluated
Mortality: not evaluated
Pain: not evaluated
Patient thermal comfort: not evaluated
Other adverse events: pre-op warming did not significantly
reduce other wound complications (haematoma, seroma,
wounds requiring aspirations)
Surgical site infection: full guideline DRAFT (April 2006)
Page 429 of 599
DRAFT FOR CONSULTATION
Cost-effectiveness evidence table (Warming)
Study
Bock et
al.
(1998)
Methods
Cost-consequences analysis
Clinical effectiveness
Randomised controlled trial
(n=40). Outcomes studied:
body temperature, intraoperative blood loss and time
to discharge from anaesthetic
recovery room.
Costing
Undertaken prospectively.
Costs included: costs of forced
air warming, labour costs
(anaesthetist and nurse),
anaesthetic equipment, and
medical treatment. Costs of
conventional care were not
included as they were the
same for both groups.
Population
Patients
undergoing
abdominal
surgery for
cancer or
inflammatory
bowel
disease.
Interventions
Intervention
Active warming using
forced air for 30min
before induction of
general anaesthesia
(40°-42°C), in
combination with
conventional
treatment (n=20).
Comparator
Conventional
treatment of
hypothermia: use of
fluid warming
devices, water
mattresses, cotton
blankets and
postoperative radiant
warming (n=20).
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
Change in core temperature:
Actively warmed patients; -0.5+/-0.8°C
Conventional care; -1.5+/-0.8°C (p<0.01)
Intra-operative blood loss:
Actively warmed patients: 635+/-507ml
Conventional care; 1,070+/-803ml (p<0.05)
Time to discharge from anaesthetic recovery room:
Actively warmed patients; 94+/-42min
Conventional care; 217+/-169min (p<0.01)
Costing
Costs of anaesthetic treatment:
Actively warmed patients; £405+/-105
Conventional care; £534+/-250 (p<0.05)
Synthesis of costs and benefits
Not applicable.
Conclusions
The authors
concluded that
the
maintenance
of
normothermia
reduced the
total costs for
anaesthetic
treatment
during major
abdominal
surgery.
Comments
Despite the trial having
a small sample size, the
authors found that
differences in main
outcomes were
significantly different
between the two
groups. Patient groups
were shown to be
comparable. The
costing study included
all relevant costs of
anaesthetic treatment.
However, other costs
accrued during the
hospital stay (i.e. length
of stay) were not
included in the analysis.
Page 430 of 599
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Study
Methods
Population
Fleishe
r et al.
(1998)
Cost-consequences analysis.
Clinical effectiveness
Randomised controlled trial
(n=100). Outcomes studied:
body temperature, patient
satisfaction, time from end of
surgery to extubation and time
to attainment of anaesthetic
recovery room discharge
criteria.
Patients at
low risk for
perioperative
complication
s undergoing
general
endotracheal
anaesthesia
for an
elective
surgical
procedure.
Costing
Undertaken prospectively.
Costs included: costs of forced
air warming and anaesthetic
recovery room costs (warmed
cotton blankets, medications
and treatment).
Interventions
Intervention
Forced air warming
(n=48)
Comparator
Routine thermal care
with warmed blankets
(n=47)
Results
Conclusions
Comments
Effectiveness
Mean patient temperature at entry to anaesthetic
recovery room:
Actively warmed patients; 36.8+/-0.1°C
Conventional care; 35.5+/-0.1°C (p<0.01)
Mean patient temperature at discharge from
anaesthetic recovery room:
Actively warmed patients; 36.7+/-0.1°C
Conventional care; 36.2+/-0.1°C (p<0.01)
Time to extubation:
Actively warmed patients; 10+/-1min
Conventional care; 14+/-1min (p<0.01)
The authors
concluded that
forced air
warming could
result in a
decreased cost
as it shortened
post-surgical
emergence
time.
The costing study
undertaken by the
authors, makes their
results difficult to
quantify and
understand.
Furthermore the method
used to cost each
intervention was not
clear.
Costing
If all operative costs were assumed to be fixed forced
air warming would cost $15 more per operation. If all
operative costs were assumed to be variable, forced air
warming would generate savings of $30 per operation.
Both interventions would cost the same if 36% of all
costs were variable.
Synthesis of costs and benefits
Not undertaken.
Surgical site infection: full guideline DRAFT (April 2006)
Page 431 of 599
DRAFT FOR CONSULTATION
Study
Mahoney
& Odom
(1999)
Methods
Cost-consequences analysis
Clinical effectiveness
Meta-analysis of 18 different
studies (n=1,575). Outcomes
studied: body temperature,
myocardial infarction, infection,
transfusion, ventilation and
mortality.
Population
Patients
undergoing
surgery. The
metaanalysis
excluded
patients with
extreme
hypothermia.
Interventions
Intervention
Forced air warming
Comparator
Warming treatments
(e.g. circulating water
blanket, humidified
air, space blanket, as
well as no treatment).
Costing
Undertaken retrospectively.
Costs included: transfusion,
ventilation, length of stay in
hospital, intensive care unit,
adverse consequences (e.g.
myocardial infarction,
infection).
Wong et
al.
(2004)
Cost-consequences analysis.
Clinical effectiveness
Randomised controlled trial
(n=42). Outcomes studied:
intra-operative and recovery
period core temperature of the
patient.
Results
Effectiveness
Lowest core temperature reached:
Forced air warming, 35.99°C
Warming treatments, 34.49°C (p<0.0001)
Infection rates:
Normothermic group, 6.95%
Hypothermic group, 19.07%, p<0.05
Transfusion:
Myocardial infarction:
Normothermic group, 2.30%
Hypothermic group, 4.07 %, p<0.05
Mortality:
Normothermic group, 2.70%
Hypothermic group, 6.01%, p<0.05
Costing
Cost savings associated with maintaining normothermia
were estimated to be between $2,495 and $7,073.56
per patient.
Female
patients
undergoing
laparoscopic
cholecystectomy.
Intervention
Forced air warming
(n=21)
Comparator
Radiant warming of
the patients’ face
(n=21)
Costing
Undertaken retrospectively.
Costs included: costs of forced
air warming (blowing unit and
blankets), and costs of radiant
warming device.
Surgical site infection: full guideline DRAFT (April 2006)
Synthesis of costs and benefits: Not relevant
Effectiveness
There was no statistical or clinical differences between
the two patient groups in terms of mean core
temperature both intra-operatively (p=0.42) and in the
recovery period (p=0.54).
Costing
Costs of forced air warming: NZ$70 for blankets, and
$2,500 for blower unit.
Costs of radiant warming: NZ$6,000.
The two warming interventions were found to incur the
same costs after 170 operations. Radiant warming
required no further ongoing cost and consumed around
half the energy.
Synthesis of costs and benefits: Not relevant
Conclusions
The authors
concluded that
in patients
whose
temperatures
were
maintained at
normal levels
during the
intraoperative
period
experienced
fewer adverse
outcomes, and
their overall
hospital costs
were found to
be lower.
Comments
The meta-analysis
included different study
designs, with 15 out of
the 18 studies included
being randomised
controlled trials. The
authors also stratified
results (core
temperature) by
comparator. Although
the costing study
included all relevant
costs related to adverse
outcomes and costs of
treatment, it did not
include the costs of
warming patients.
The authors
concluded that
the reduced
running costs
of radiant
warming
compared to
forced air
warmers made
this device an
attractive
alternative for
active warming
in operative
room.
Cost results from this
randomised controlled
trial were not
undertaken from a
detailed costing study,
but by assuming a cost
for each resource use
component (i.e. blanket,
blower unit and radiant
warming). Therefore the
cost results from this
RCT undertaken in New
Zealand need to be
treated with caution.
Page 432 of 599
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D13: PERIOPERATIVE OXYGEN FOR THE PREVENTION OF SURGICAL SITE INFECTION
Clinical Effectiveness
Author
Belda
2005
Spain
Greif
2000
Austria and
Germany
Participants
Inclusion: 300 patients aged 18-80
years who underwent elective colorectal
surgery
Exclusion: Minor colon surgery or
laparoscopic surgery; expected time of
surgery <1 hour; fever or existing
infection; diabetes mellitus; HIV
infection; weight loss >20% in previous
3 months; serum albumin <30g/L;
leucocyte count < 2500cells/mL
Interventions
30% (n=143) or 80% (n=148) inspired oxygen
intraoperatively and for 6 hours after surgery.
Outcomes
Surgical site infection rate (CDC definitions and
ASEPSIS score>20):
35/143 (24.4%) on 30% O2 and 22/148 (14.9%) on 80%
O2, p=0.04.
RR 0.61 (95% CI 0.38-0.98)
After adjusting for confounding variables, RR 0.46
(95%CI 0.22-0.95)
Number of patients with ASEPSIS score >20 on any day:
37/143 (25.9%) on 30% O2 and 25/148 (16.9%) on 80%
O2, p=0.06.
Length of stay:
Mean 10.5 (4.4) days on 30% O2 and 11.7 (7.0) on 80%
O2, p=0.09.
Inclusion: 500 patients aged 18-80 yr
undergoing elective open colorectal
resection, mostly for cancer or
inflammatory bowel disease
Exclusion: Minor colon surgery; recent
fever or infection; serious malnutrition;
bowel obstruction
30% oxygen vs. 80% oxygen after intubation, during
procedure and for 2 hours after; 100% during extubation.
Surgical site infection rate (pus expressed from
incision or aspirated from mass within wound):
28/250 (11.2%) on 30% O2 vs. 13/250 (5.2%) on 80% O2,
p=0.01.
ASEPSIS score
5 (9) vs. 3 (7), p=0.01. Higher score = poorer healing and
greater likelihood of infection
Length of stay:
11.9 (4.0) vs. 12.2 (6.1), p=0.26
Mortality:
6/250 (2.4%) on 30% O2 vs. 1/250 (0.4%) on 80% O2,
p=0.13
Surgical site infection: full guideline DRAFT (April 2006)
Page 433 of 599
DRAFT FOR CONSULTATION
Author
Mayzler
2005
Israel
Pryor
2004
USA
Whitney
2001
USA
Participants
Inclusion: 38 patients undergoing
elective colorectal cancer surgery
Exclusion: ASA classification 3 or 4;
BMI≥35; diabetes mellitus; COPD;
serious malnutrition;
immunosuppression
Interventions
30% oxygen vs. 80% oxygen after intubation, during
procedure and for 2 hours after
Outcomes
Surgical site infection rate (erythema, local pain and
drainage of fluid or purulent secretion):
2/19 (12.5%) on 80% O2 vs. 3/19 (17.6%) on 30% O2, NS
Inclusion: 160 patients undergoing
major intra-abdominal surgery older
than 18 yr
Exclusion: Laparoscopic procedures;
respiratory status requiring O2>35%;
severe COPD; haemodynamically
unstable; ASA category 5 or 5E.
35% oxygen vs. 80% oxygen after intubation, during
procedure and for 2 hours after; 100% permitted for
preoxygenation, induction, emergence and extubation; O2
could be increased as required during procedure to
maintain SaO2>94% by pulse oximetry.
Inclusion: 24 subjects aged 18-80 yr
having cervical spine surgical
procedures
Exclusion: Unable to read & speak
English, unable to give informed
consent; discharged from
postanaesthesia care unit with
supplemental oxygen
Interventions: 28% oxygen for 1st 36 postoperative hours
(n=13) vs. room air (n=11)
Surgical site infection rate (from record review –
documented SSI, antibiotics, aspiration plus at least
3 of raised WBC, temperature>38.5C, radiological
evidence of infection, pus from wound, positive
culture from wound or erythema and induration that
resolved with treatment)
20/80 (25%) on 80% O2 vs 9/80 (11.3%) on 35% O2 vs.
p=0.02.
Length of stay:
6.4 (4.7) days on 35% O2 vs 8.3 (7.5) days on 80% O2 vs.,
NS
Mortality:
1/80 died on 35% O2; none died on 80% O2.
Surgical site infection rate (ASEPSIS score on neck
wound and where appropriate thigh skin graft
wound):
All patients had ASEPSIS score in range of satisfactory
healing (0-10); no significant differences between mean
scores of groups (data not shown).
Incision redness: 1 in each group
Surgical site infection: full guideline DRAFT (April 2006)
Page 434 of 599
DRAFT FOR CONSULTATION
D14: INTRA-CAVITY SOLUTIONS
Clinical Effectiveness
Study
Anglen
2005
Participants
Inclusion: 400 adult patients with an
open fracture of the pelvis or lower
extremity (n=458 fractures)
Exclusion: Prisoner status, inability to
obtain adequate consent,
immunosuppression, pre-existing
infection at site of fracture, allergy to
study ingredients
Baseline comparability: Yes for gender,
smoking, alcohol use and injury severity
score. No for:
Age: group B younger (38 vs. 42 yr,
p=0.01),
Type of injury: group B had more highimpact injuries from motor vehicles
(p=0.025; group C patients more likely
to be injured in falls, possibly explained
by older age group),
Hypotension: Group B had more
hypotension (23% vs. 14%, p=0.04)
Use of antibiotics: Group B had
intravenous antibiotics for longer (11 vs.
9 days, p=0.02; probably due to
complications).
Loss to follow-up: 13% in group A and
11% in group B (12% overall)
Interventions
A: Irrigation with detergent solution (nonsterile castile
soap solution) (n=208 patients; outcome data available
for 180 patients with 199 fractures)
B: Irrigation with antibiotic additives (bacitracin) (n=192
patients; outcome data available for 171 patients with 199
fractures)
Outcomes
Wound infection (deep = drainage of culture-positive
purulent fluid, or positive culture of deep tissue;
superficial if erythema, streaking, swelling, warmth,
tenderness, fever, requiring antibiotics):
A: 26/199 fracture sites (13%)
B: 35/199 (18%), NS
The amount of irrigating fluid and the use of other
antibiotics was determined by the grade of fracture
according to a protocol
Bone healing delayed (non-union or delayed union of
bone requiring additional treatment to encourage
healing):
A: 46/199 (23%)
B: 49/199 (25%), NS
Follow up: Group B followed up for longer (560 vs. 444
days, p=0.01; follow up was until an infectious or healing
complication occurred or the patient was discharged from
care with a healed fracture and soft tissue envelope, so
this is an artifact of the healing complications in group B),
Surgical site infection: full guideline DRAFT (April 2006)
Wound healing problems (dehiscence, death of flap or
graft, failure to heal not due to deep infection):
A: 8/199 (4%)
B: 19/199 (9.5%), p=0.03
Page 435 of 599
DRAFT FOR CONSULTATION
Author
Baker 1994
Participants
Inclusion: 300 patients undergoing
elective colorectal surgery
Exclusion: Unable to consent; not
colorectal surgery; found to be
inoperable; overt sepsis or severe
faecal spillage during procedure
Interventions
A: Peritoneal lavage before wound closure with 2%
taurolidine in 5% polyvinyl pyrrolidine (n=150)
B: Lavage with normal saline (n=150)
Wound swabbed before and after instillation of lavage
solution:
more of the patients whose swabs were initially positive
(28/150) in the taurolidine group demonstrated reduced
microbial contamination (17 patients, 61% of infected,
improved) than among the saline-treated group (initially
35/150 contaminated; 8/35 [23%] improved) – not stated
as an a priori hypothesis
Baseline comparability: Yes except
more anterior resections in taurolidine
group (46 vs. 24)
Loss to follow-up: 0.3%
Cheng
2005
Inclusion: 414 patients undergoing
spinal surgery (e.g. decompression,
pedicle screw fixation, discectomy or
tumour excision) In Taiwan
Exclusion: 2 patients who died during
follow up period; fever or suspected
infection; overt or suspected pyogenic
vertebral osteomyelitis discitis or any
form of pre-operative spinal infection
Outcomes
Wound infection (spontaneous or incisional drainage from
wound, either of pus or serous fluid, positive for infecting
organism on culture):
17 wound infections in each group.
A: Dilute 3.5% betadine (povidone-iodine; n=208)
B: No betadine irrigation (n=206)
Median length of stay: 18 days in each group.
Wound infection (including wound discharge, dehiscence
and erythema; all culture positive):
A: None
B: 1 superficial (0.5%) + 6 deep (2.9%) infections
Difference between total infection rates: p=0.0072
Baseline comparability: Not stated
Loss to follow-up: Not stated
Surgical site infection: full guideline DRAFT (April 2006)
Page 436 of 599
DRAFT FOR CONSULTATION
Author
Magann
1993
Participants
Inclusion: 100 patients having
Caesarean section
Exclusion: Chorioamnionitis;
emergency operation for fetal distress;
patient refusal
Baseline comparability: Yes
Loss to follow-up: None
Interventions
A: Standard skin preparation plus normal saline irrigation
of pelvis (n=25)
B: Standard skin preparation plus antibiotic irrigation of
pelvis (n=25)
C: Special skin preparation with parachlorometaxylenol
plus normal saline irrigation of pelvis (n=25)
D: Special skin preparation with parachlorometaxylenol
plus antibiotic irrigation of pelvis (n=25)
Outcomes
Wound infection (Hyperemic skin incision and fluctuant
mass that when opened contained purulent material):
A: 3/25
B: 2/25
C: 1/25
D: none, NS
Endometritis:
A: 16/25
B: 8/25
C: 14/25
D: 3/25, p<0.001
Combining B+D: 11/50 (22%) vs A+C: 30/50 (60%)
Surgical site infection: full guideline DRAFT (April 2006)
Page 437 of 599
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D15:INTRA-OPERATIVE SKIN ANTISEPTICS
Clinical Effectiveness
Study
Participants
Cordtz
(1989)
Denmark
1340 patients requiring
aesarean section
Inclusion: elective and
emergency aesarean section
Exclusion: history of sensitivity
to iodine
Baseline comparability: no
details
Interventions
Interventions: Preoperative skin disinfection for all
patients :2.5% iodine in 70% ethanol
Patients then randomised to groups:
d) Redisinfection
e) Without redisinfection
f) Incisional drape with redisinfection
g) Incisional drape without redisinfection
(Redisinfection defined as disinfection of the skin around
the incision site with 2.5% iodine and 70% ethanol, shortly
before skin closure)
Drapes not used:
Redisinfection: 25/324
Without redisinfection: 29/354
Outcomes
Outcomes:
-Possibly infected: localised erythema and/or serous
secretion without presence of pus
-Infected: presence of pus irrespective of the results of
bacteriological examination
Results:
1. Total redisinfection vs. without redisinfection
Possibly infected:
Redisinfection: 42/649
Without redisinfection: 65/691
Infected
Redisinfection: 30/649
Without redisinfection: 36/691
9. Drapes used (possibly infected and infected):
Redisinfection: 41/325
Without redisinfection: 58/337
10. Drapes not used (possibly infected and
infected):
Redisinfection: 31/324
Without redisinfection: 43/354
11. Prophylactic antibiotics
Drapes used:
Redisinfection: 20/325
Without redisinfection: 36/337
Surgical site infection: full guideline DRAFT (April 2006)
Page 438 of 599
DRAFT FOR CONSULTATION
Study
Gray
1981
UK
Walsh
1981
Australia
Participants
156 patients undergoing elective
abdominal surgery and
classified as: biliary, gastro
duodenal, intestinal and other
Exclusion: emergency surgery,
known allergy to iodine
Baseline comparability: no bias
in patient allocation for category
of operation
Interventions
Skin preparation before operation was carried out with
chlorhexadine gluconate in 70% alcohol. Following
closure of the peritoneum with catgut, the patients were
randomised to two groups:
a) dry powder povidone iodine spray
b) b) no redisinfection
Outcomes
Outcomes:
Infection classified as a) major with copious purulent
discharge, b) minor with scanty discharge of pus, c) no
infection
Results:
Major infection
Group a) 3/64
Group b) 7/62
627 patients (314 males, 313
females), mean age 43.2, 28%
obese.
Operations included:
226 appendicectomy
166 biliary tract
41 colonic procedures
63 gastro duodenal
131 miscellaneous
405 patients did not receive
antibiotics at any time
Inclusion: abdominal procedures
Exclusion: no details
Baseline comparability: no bias
in patient allocation for category
of operation
Wounds were stratified on the
basis of expected contamination
a) clean, b) potentially infected,
c) dirty
Standard skin preparation with povidone iodine was used.
Following closure of the peritoneum, patients were then
randomised to groups:
a) wound spraying with povidone iodine solution
b) no redisinfection (control)
Outcomes:
Infection defined as:
-purulent discharge present with or without bacteriological
analysis OR
- serosanguinous discharge was positive on culture
All within one month of surgery
Surgical site infection: full guideline DRAFT (April 2006)
Results:
All patients
Group a) 28/308
Group b) 40/319
Page 439 of 599
DRAFT FOR CONSULTATION
D17: SURGICAL METHODS OF CLOSURE OF AN INCISION SITE FOR THE PREVENTION OF SURGICAL SITE INFECTION
Clinical Effectiveness
Study
Anatol
199719
Setting:
Trinidad
Centres:
Single
Years: 1990
to 1992
Study:
Angelini
19851
Setting: UK
Centres:
Assumed
single
Years: dns
Sample size:
205
Trial Participants
Population: Children under age of 15
with groin crease incision requiring day
surgery
Type of wound: Inguinal
herniotomy=150, orchidopexy=25,
hydrocoele=13, variocoele=1,
epididymal=cyst
Age: <15 years
Baseline comparability: no information
reported
Interventions
1.Catgut subcuticular interrupted 3/0 plain
(n=62)
2. Polyglactin (Vicryl) subcuticular continuous 3/0
(n=76)
3. Skin tapes
(n=52)
65.3% completed overall
All patients had closure of deeper layers with chromic
catgut, no subcutaneous sutures were used
Sample size: 190 wounds, 23 children
had bilateral incisions
Study duration: Minimum follow-up 11 months
Population: Participants were
undergoing open heart or thoracic
surgery
1.Nylon continuous vertical mattress suture 2/0
monofilament polyamide for skin closure
(n=70)
Type of wound:
Age: Mean 48.6 years
Baseline comparability: States groups
comparable for age, sex, weight and
incision length
2.Polyglycolic acid 2/0 continuous subcuticular suture for
skin closure
(n=71)
3.Op-site sutureless skin closure
(n=64)
Completion rates not reported
Concomitant treatment: Apart from group 3 all wounds
covered with light cotton gauze dressing for first 48 hours
then left exposed. Standard antibiotic regimen used in all
patients until removal of last chest drain
Study duration: 45 days
Surgical site infection: full guideline DRAFT (April 2006)
Outcome measures & Results
Wound infection defined not defined
Assessed at: 1 week, 6 weeks, 3 and 6 months post-op.
Assessor: independent nurse observer.
Outcomes: Uneventful healing defined as absence of
any of the wound complications listed below,
Complications sought were: erythema, induration,
discharge, raw areas, spreading or thickening of scar and
stitch sinuses, extrusions, time taken for wound healing
SSI rates: 20/62 Group Catgut
21/ 52 Group Tapes
14/76Group Polyglactin
Significant association between closure method &
successful outcome( P=0.05).
Mortality: not stated
Wound infection defined as: purulent discharge with
positive cultures
Assessed at: 5, 10 and 45 days post-op
Wound infection reported at 5 days.
Assessor: independent observer(no details)
Outcomes: Wound Inflammation, oedema, discharge and
infection. Score 0-4 for inflammation, edema and
discharge. Wound state categorised as well healed,
healed with residual inflammation, skin overlap, and skin
dehiscence day 10. Overall result excellent, good, fair or
poor at 5 weeks post-discharge.
SSI rate: 2/70 Group Nylon
1/71 Group Dexon
1/64Group Op-site
No significant difference.
Mortality: not stated
Page 440 of 599
DRAFT FOR CONSULTATION
Study
:Angelini
1984
Setting:UK
Centres:
Single
Years:
Sample
size: 113
Trial Participants
Inclusion: adult patients undergoing
coronary artery bypass grafting,
Interventions
1. Continuous vertical mattress suture of 2/0 nylon
(Ethicon) (n=27)
Exclusion: none stated
Baseline comparability: yes (age, sex,
body weight, length of leg incision)
Mean age 49-55 yr (depending on
group)
2. Continuous subcuticular suture of 2/0 polyglycolic aid
(Dexon) (n=29)
3. Disposable metal skin staples (n=27)
4. Op-site sutureless skin closure (medium drape) (n=30)
Arroyo
2001
Setting:Spai
n
Centres:
1992 –1998
Inclusion: adult patients with primary
umbilical hernia, mean age 57 yr
Exclusion: High anaesthetic risk or
emergency surgery
Baseline comparability: yes
Loss to follow-up: not stated
Outcome measures & Results
Wound infection defined as purulent discharge with
positive cultures.
Assessed at: 5,10 & 45 days post op.
Assessor: independent observers (no details).
Wound infection at day 5:
A: 2/27
B: 0/29
C: 1/27
D: 1/30
Wound dehiscence at day 10:
A: 4/27; B: 0/29; C: 3/27; D: 1/30
Cosmetic appearance at 45 days (independent
assessment):
Excellent: A: 7/27; B: 19/29; C: 8/27; D: 14/30
Good: A: 11/27; B: 9/29; C: 13/27; D: 13/30
1. Primary suture (herniorraphy) (n=100)
2. Polypropylene mesh or plug (hernioplasty) (n=100)
Wound infection not defined
Assessed at: not stated
Assessor: not stated
Wound infection:
3 (3%) in A versus 2 (2%) in B
Sample size: 200
Study:
Beresford
1993
Setting:
Canada
Centres:
Single
Inclusion: patients having elective
abdominal hysterectomies
Exclusion: Other surgical procedure,
not low transverse incision, prophylactic
antibiotics required
Baseline comparability: yes
Loss to follow-up: Not stated
1. Absorbable staples (n=48)
2. Sutures (n=46)
Hernia recurrence:
11 (11%) in A versus 1 (1%) in B, p=0.0015
Mortality: None
Wound infection not defined
Assessed at: 6 & 18 weeks
Assessor: not stated
Wound infection: 5 (11%) in A versus 4 (9%) in B
Sample size: 94
Surgical site infection: full guideline DRAFT (April 2006)
Page 441 of 599
DRAFT FOR CONSULTATION
Study
Study:
Bhatia 2002
Setting: UK
Centres:
Single
Years:
2000- 2001
Study:
Bottio 2003
Setting:
Italy
Centres:
Single
Years:
1999- 2002
Trial Participants
Inclusion: 31 patients having surgery
for Dupuytren’s contracture, mean age
61 yr
Exclusion: Not stated
Interventions
1. Staples (n=13)
2. Interrupted sutures (n=18)
Baseline comparability: Not stated
Loss to follow-up: none
Sample size: 31
Inclusion: patients undergoing cardiac
operations through median sternotomy
Exclusion: not stated
Wound infection: None in A versus 1 in B.
Mean pain score for removal:
5.2 in A versus 2.4 in B (no SDs given), p=0.008
1. Double crisscross sternal wire closure (n=350)
2. Standard trans-sternal closure (n=350)
Setting: UK
Centres:
Assume
single
Years: dns
Sample
size: 194
hernias
Wound infection defined using guidelines for reporting
sternal wound infections – no details given
Assessed at: not stated
Assessor: not stated
Baseline comparability: yes
Superficial wound infection:
None in A versus 7 (2%) in B, p<0.05
Deep sternal wound infection:
None in A versus 6 (1.7%) in B, p<0.05
Loss to follow-up: not stated
Length of follow up: not stated
Blinding of outcome assessors: not
stated
Sample size: 700
Study:
2
Cahill 1989
Outcome measures & Results
Wound infection defined on 1-10 scale, not clearly
defined
Assessed at: 7 & 14 days
Assessor: not stated
Population: Adults undergoing elective
inguinal hernia repair, n=23
synchronous bilateral repair, 2 bilateral
hernia repairs 1 month apart, 67%
inpatients, median hospital stay 4 days
(range 2-20), adolescents and
recurrent hernias excluded
Type of wound: As above
Age: dns
Baseline comparability: No baseline
information reported
Nylon No 1 monofilament
(n=64)
Polybutester No 1
(n=61)
Polytetrafluoroethylene (PTFE)
(n=69)
% completing not reported
Repaired using darn technique, 23 patients underwent
synchronous bi-lateral repair, 2 had bi-lateral repairs 1
month apart
Study duration: 1 month
Surgical site infection: full guideline DRAFT (April 2006)
Mortality: 15 (4.3%) in A versus 16 (4.6%) in B
1 patient died from deep wound infection with sternal
instability.
Wound Infection defined as: tenderness,
swelling,erythema + discharge
Assessed at; 4 weeks post op
Assessor: not stated
Outcomes: 1 month wound healing and infection,
admission to hospital
SSI rate:
Deep infection 0/64 Group Nylon
0/61 Group Polybutester
4/69 Group PTFE
statistically significant: P<0.05
Superficial infection 13/194 (no group details given)
Mortality: 1/194 (died of a stroke before 1 month
assessment)
Page 442 of 599
DRAFT FOR CONSULTATION
Study
Study:
Cameron
19873
Setting: UK
Centres:
Single
Years: dns
Sample
size: 301
Trial Participants
Population: Patients undergoing
emergency and elective laparotomy by
vertical abdominal incision under the
care of three consultants, re-operations
through same excision excluded
Type of wound: gastric=31.5%,
biliary=48.3%, colonic=38.6%,
other=35.9%
Age: Mean 61 years
Baseline comparability: Excess colonic
sugery in Prolene group otherwise well
balanced
Interventions
No 1 gauge polydioxanone (PDS)
(n=143; 69.9% completed)
No 1 polypropylene (Prolene)
(n=141; 63.8% completed)
17 patents excluded due to death or re-operation within
14 days, group assignment not reported
Interrupted mass figure-of-eight suture beginning and
ending beneath rectus sheath to bury knots, skin closed
with clips or nylon, most patients received subcutaneous
heparin, bowel preparation and antibiotic prophylaxis
according to surgeon's usual practice.
Study duration: Minimum 12 months follow-up, mean 14.7
months
Outcome measures & Results
Wound infection defined as: discharge of pus within one
month post-operative period
Assessed at: up to 1 month post op
Late assessment for insicional hernia: by 1 registrar blind
to method of closure at 12 months post op.
Assessor: House officers
Outcomes: Wound infection, abdominal distension, chest
infection, 12 month presence/albescence palpable knots,
incisional hernia, pain
SSI rate: 12/143 Group A
21/141 Group B
No statistically significant difference.P=0.11
Wound dehiscence: 1/143 Group A
9/141 Group B
No significant difference P=>0.05
Incisional hernia: 10/100Group A
11/90 Group B
No statistically significant difference.P=0.8
Mortality: Not stated
Surgical site infection: full guideline DRAFT (April 2006)
Page 443 of 599
DRAFT FOR CONSULTATION
Study
Study:
Carlson
19954
Setting:
USA
Centres:
Single
Years: dns
Sample
size: 225
Trial Participants
Population: Patients undergoing
laparotomy through vertical midline
incision, elective and emergency
procedures (clean and cleancontaminated wounds), patients with
less than 2 years life expectancy,
peritonitis and pre-existing ventral
hernia excluded
Type of wound: as above
Age: dns
Baseline comparability: Procedure
status (elective v emergency) wound
class and presence or absence of colon
procedure not different between
groups, no other baseline data reported
Interventions
0-looped nylom (Ethilon)
(n=112; 82% completed)
0-looped polyglyconate (Maxon)
(n=113; 72% completed)
Running mass closure by Senior or Chief residents
incorporating both layers of rectus sheath, technique for
skin closure surgeon choice, prophylactic antibiotics for
clean contaminated cases,
Outcome measures & Results
Wound infection not defined
Assessed at: 2 and 6 weeks, 6 and 12 months, and 2
years,
Assessor:
Outcomes: Early post-operative wound complications
(including infection and dehiscence), incisional hernia and
dehiscence
SSI rate: 4/112 Group A
2/113 Group B
No statistically significant difference
Study duration: 2 years
Incisional hernia: 4/112 Group A
7/113 Group B
No statistically significant difference.
Wound dehiscence: 3/112 Group A
0/113 Group B
No significant difference P=>0.05
Mortality: 11/225 Deaths not related to failure of incision
closure.
Cheng
1997
86 male patients under the age of 12
years requiring elective circumcision
were entered into the study. Duchess of
Kent Hospital, Hong Kong. Patients
were healthy. No specific exclusion
criteria were described.
Cyanoacrylate (Histoacryl®) tissue adhesive versus 4.0
catgut sutures. 40 patients were in the adhesive group
and 46 patients were in the suture group.
One-month follow-up randomised
parallel group study. The reason for
withdrawals was not clear and there
was no reply following writing to the
authors.
Surgical site infection: full guideline DRAFT (April 2006)
Wound infection defined as: wound discharge with
positive cultures.
Assessed at 7days & 1 month post op
Assessor: not stated
Dehiscence and infection at day 1, 2, 3, 7 and 30.
Cosmetic appearance, bleeding and wound inflammation
were also assessed at these time points.
Notes - Cosmetic appearance data not used as less than
3 months.
Page 444 of 599
DRAFT FOR CONSULTATION
Study
Trial Participants
Chughtai
2000
Inclusion: 162 patients undergoing
coronary artery bypass grafting
(elective or emergency)
Exclusion: Not stated
Interventions
A: Sternal and leg incisions closed with clips (n=81)
B: Sternal and leg incisions closed with subcuticular
sutures (n=81)
Baseline comparability: yes except clip
group had more women (32.1% versus
17.3%, p=0.03) and more patients with
diabetes (29.6% versus 16.0%, p=0.04)
Loss to follow-up: Not stated
RCT
Length of follow up: 3-6 weeks after
discharge
Blinding of outcome assessors: No
Power calculation: Not stated
Surgical site infection: full guideline DRAFT (April 2006)
Outcome measures & Results
Wound infection defined
Assessed at: not stated
Assessor: not stated
In hospital:
Sternal wound infection (redness plus discharge or
wound required re-opening or patient required
antibiotics):
2 (2.5%) in A versus 1 (1.2%) in B, p=0.55
Mediastinitis:
1 (1.2%) in A versus 1 (1.2%) in B, p=0.99
Leg wound infection ( assessed 3-6 weeks post
discharge by same surgeon):
1 (1.2%) in A versus 2 (2.5%) in B, p=0.58
At follow up (final denominators not stated):
Sternal wound infection:
6 (7.4%) in A versus 1 (1.2%) in B, p=0.05.
Sternal wound dehiscence:
4 (4.9%) versus 2 (2.5%), p=0.39
Mediastinitis:
2 (2.5%) in A versus 0 in B, p=0.15
Leg wound dehiscence:
7 (8.6%) in A versus 8 (9.9%) in B, p=0.77
Leg wound infection:
9 (11.1%) in A versus 9 (11.1%) in B, p=0.98
Leg pain: 4 (4.9%) in A versus 7 (8.6%) in B, p=0.37.
Cosmetic appearance at 6 weeks: No significant
difference in either sternal or leg wounds
Average cost per case (no SDs given): Canada $15 in A
versus 4.5 in B.
Page 445 of 599
DRAFT FOR CONSULTATION
Study
Study:
Chowdhury
19935
Setting:
India
Centres:
Single
Years: 1989
to 1990
Sample
size: 160
Cohn
2001
USA
Trial Participants
Population: Patients needing
emergency or elective abdominal
surgery, patients needing Gridiron,
Pfannenstiel incisions for kidney
exposure and hernia operations
excluded
Type of wound: Biliary=26.3%.
gastric=30%, intestinal 21.3%,
others=22.5%
Age: Range 10 to 78 years
Baseline comparability: Nylon group
have more patients with risk factors for
poor wound healing
Inclusion: 51 patients with dirty
abdominal wounds related to perforated
appendix, other perforated viscus,
traumatic injury > 4hours old with
retained devitalised tissue, or intraabdominal abscess, or pre-existing
clinical infection
Exclusion: Not stated
Interventions
1. Mass closure with monofilament nylon No 1,
abdominal wall closed with interrupted near and far
technique incorporating all layers of abdominal wall taking
bites 1-1.5 cm from incision edge. No deep tension
sutures used, few coaption sutures with nylon as
necessary
(n=80; % completed)
2.Layer closure with continuous chromic catgut No 1 for
peritoneum and muscle layer, skin and subcutaneous
tissue closed with cotton thread
(n=80; % completed)
All patients received antibiotics 3-5 days postoperatively
and vitamin B and C
Study duration: One to 15 months
A: Delayed primary closure (evaluated at day 3 for
closure on day 4 with adhesive strips if pristine i.e. no
drainage; if not [46%] then daily dressing changes)
(n=26)
B: Primary closure with skin staples (n=23)
Power calculation: yes – this calculated 80 patients
required per group but only 51 randomised, i.e.
underpowered
Baseline comparability: yes except
more men in group B (21 men + 2
women versus 16 men + 10 women in
A)
Loss to follow-up: 2 patients (3.9%)
died <72 hours after surgeryRCT
Length of follow up: 1 month
Outcome measures & Results
Wound Infection defined as: purulent discharge,
Assessed at : up to 13 days post op (unclear) + 1-15
months
Assessor: not stated
Outcomes: Wound infection , wound dehiscence,
incisional hernia assessed one to 15 months post-op.
SSI rate: 18/80 Group A
38/80 Group B
statistically significant: P<0.001
Incisional hernia within 1 yr of surgery:
No statistically significant difference.
Wound dehiscence: 0/80 Group A
3/80 Group B
Mortality: Nil
Wound infection defined
Assessed at: day 3 + 1 & 4 weeks after discharge
Assessor: surgical house officers
Definite wound infection (purulent discharge) or possible
wound infection (signs of inflammation or serous
discharge):
1 definite+2 possible in A (total 3/26; 12%) versus 11/23
(not separated into definite and possible) (48%) in B,
p=0.013
Costs (hospital charges; excludes 1 patient staying 38
days for social reasons):
Those requiring ITU (n=18): $227,237 in A versus
$78,101 in B (NS)
Those not requiring ITU (n=31):
$22,258 in A versus $26,352 in B (NS) (no SDs given)
NB figures do not match between text and tables for p
value
Surgical site infection: full guideline DRAFT (April 2006)
Page 446 of 599
DRAFT FOR CONSULTATION
Study
Colombo
1997
Italy
Trial Participants
Inclusion: 617 patients with vertical
midline laparotomy for gynaecological
cancer
Exclusion: Not stated
Baseline comparability: yes
Loss to follow-up: 3 patients (0.5%)
died 28-59 days after surgery RCT
Length of follow up: 6 months – 3 yr
Blinding of outcome assessors: yes
Power calculation: no
Study:
Corder
19916
Population: Patients undergoing high
saphenous vein ligation and no other
procedure, unilateral or bilateral
Setting: UK
Centres:
Single
Type of wound: as above
Age: Range 16 to 74 years
Baseline comparability: No baseline
information reported
Years: 1988
to 1999
Sample size: 126 patients with 161
wounds
Interventions
A: Continuous mass closure (n=308)
B: Interrupted mass closure (n=306)
Outcome measures & Results
Wound infection defined as purulent discharge +/positive culture
Assessed at: daily as in patient,14 days post discharge,
2-3 month intervals for 1 yr.
Assessor: not stated
Wound infection (purulent discharge):
3 (1%) in A versus 5 (1.6%) in B, NS
Superficial wound dehiscence:
None in A versus 4 (1.3%) in B
3/0 subcuticular polyglycolic acid (PGA)
(n=75)
Interrupted monofilament nylon mattress sutures (IMNM)
(n=86)
98% completed overall
Chlorhexidine skin preparation and chromic catgut used
for all other sutures, apart from skin closure all other
procedures identical, 11 different surgeon’s performed
operations
Deep wound dehiscence:
1 (0.3%) in A versus none in B
Incisional hernia:
32 (10.4%) in A versus 45 (14.7%) in B, NS
Wound infection defined as: discharge of pus without
bacteriological confirmation
Assessed at: 6 weeks,
Assessor: patient
Outcomes: Wound Infection
SSI rate: 15/75 Group PGA
7/86 Group IMNM
statistically significant: P<0.05
The higher rate in Group PGA appeared to be operator
dependent.
Mortality: not stated
Study duration: 6 weeks
Surgical site infection: full guideline DRAFT (April 2006)
Page 447 of 599
DRAFT FOR CONSULTATION
Study
Efem 1988
Setting:
Nigeria
Centres:
Single
Years: July
1982-June
1985
Sample
size: 314
Eldrup
1981
Denmark
Fagniez
1985
France
Trial Participants
Inclusion: patients of indigenous
Negroid ancestry having vertical
midline major laparotomy;
Exclusion: Paramedian, transverse,
oblique, gridiron, Pfannenstiel,
Rutherford-Morrison incisions
Age range 2 months to 95 yr
Interventions
1. Mass closure (continuous figure of eight) (n=109)
2. Layered closure (catgut for peritoneum, polyamide for
rectus sheath, catgut for fat layer) (n=205)
Major wound infection severe enough to delay discharge
from hospital:
4 (3.7%) for group A versus 21 (10%) for group B.
Baseline comparability: Not stated
Loss to follow-up: 10%RCT
Length of follow up: 4 and 14 days
post-op; 6-18 months in clinic
Blinding of outcome assessors: not
stated
Power calculation: No
Inclusion: 137 patients undergoing
elective abdominal and breast surgery
and having a skin incision between 15
and 35 cm long
Exclusion: Not stated
Baseline comparability: Not stated
Loss to follow-up: Not stated
Inclusion: 3135 patients having a
longitudinal abdominal midline incision
Exclusion: Other incisions;
reoperations; treated for wound hernia
Outcome measures & Results
Wound infection defined
Assessed at: 4 days post op + swab for culture &
sensitivity, 6-18 months
Assessor: not stated
Acute wound failure (burst abdomen): None in group A
versus 6 (3%) in group B
Delayed wound failure (incisional hernia):
None in group A versus 4 (2%) in group B.
A: Staples (n=69)
B: Suture (n=68)
Mortality:
None in A versus 2 in B
Wound infection not defined
Assessed at: not stated
Assessor: not stated
Wound infection:
3 in A versus 7 in B, NS
A: Continuous sutures for fascia (n=1,566)
B: Interrupted sutures for fascia (n=1,569)
Baseline comparability: no - more
patients in B received antibiotics
(949/1569 versus 835/1566, p<0.001)
Loss to follow-up: not stated
Surgical site infection: full guideline DRAFT (April 2006)
Cost ratio between stapler and Dermalon suture is 47:1
(140 to 3 Danish kroner) (no SDs given)
Wound infection not defined
Assessed at: within 30 days post op.
Assessor: not stated
Wound dehiscence:
Clean:
2/512 in A versus 7/512 in B, NS
Clean/contaminated:
9/663 in A versus 9/668 in B, NS
Dirty:
10/388 in A versus 21/392 in B, p<0.05
Page 448 of 599
DRAFT FOR CONSULTATION
Overall:
From Table 4:
21/1563 (1.6% in text; 1.3% by calculation) in A versus
37/1572 (2% in text; 2.4% by calculation) in B; in another
table (Table 5), the totals stated are 26 in A (which would
match the 1.6%) versus 32 (which would match the 2%)
in B, NS
Wound abscess:
107/1566 in A versus 93/1569 in B, NS
Death: 92 in A versus 124 in B, p<0.05
Farnell
1986
USA
RCT
Length of follow up: 6-8 weeks – patient
report of infection
Blinding of outcome assessors: yes
between groups B and C
Power calculation: yes
Inclusion: Patients undergoing abdominal operations with
clean-contaminated, contaminated or dirty wounds 3,282
incisions; mean age 54.4yr
Exclusion: Clean wounds; allergy to povidone, iodine,
neomycin, polymyxin or gentamicin; laparotomy in
previous 12 weeks; vascular, urologic or gynaecological
procedures
Baseline comparability: not stated
Loss to follow-up: 4.5%
Surgical site infection: full guideline DRAFT (April 2006)
NB Numbers in different tables not consistent; big
difference in major confounding factor (i.e. use of
antibiotics) – not stated how it was decided whom to give
these to; not adjusted for in analysis; not clear if given
before or after evidence of infection
Wound infection defined
Assessed at: alternate days until discharge, 6-8 weeks
post discharge
Assessor: nurse
Wound infection (drainage of purulent material or culture
positive):
Clean-contaminated wounds:
A: 27/659 (4.1%)
B: 26/678 (3.8%)
C: 29/678 (4.3%)
D: 29/659 (4.4%)
NS
Contaminated wounds:
A: 7/99 (7.1%)
B: 5/105 (4.8%)
C: 7/97 (7.2%)
D: 4/103 (3.9%)
NS
Dirty wounds:
A: 7/45 (15.5%)
B: 5/53 (9.4%)
C: 3/53 (5.7%)
D: 12/53 (22.6%)
P=0.55
Page 449 of 599
DRAFT FOR CONSULTATION
Study
Gainant
1989
France
Trial Participants
Inclusion: 100 patients having
gastrointestinal surgery, at high risk of
wound dehiscence
Exclusion: Not stated
Interventions
A: Resorbable internal polyglactin mesh (n=50)
B: Externally applied Polyamide fibre mesh (n=50)
Outcome measures & Results
Wound infection defined
Assessed at: up to 1 month post op.
Assessor: not stated
Wound dehiscence (disruption of every surgical layer,
requiring surgical closure):
None in A versus 8 (16%) of which 5 due to infection in B,
p<0.01
Baseline comparability: yes
Loss to follow-up: none at 1 month RCT
Length of follow up: At least 1 month
Blinding of outcome assessors: no
Power calculation: not stated
Wound abscess 12 (24%) in A versus 9 (21.4%) in B, NS
Wound healing:
Mean 17 days in A versus 23 days in B (SDs not stated)
Study:
Gennari
2004
Setting:
Italy
Centres:
Years:
Sample
size: 133
Inclusion: patients having breast
surgery for breast cancer or benign
mammary lesions
Exclusion: Insulin-dependent diabetes
mellitus, blood-clotting disorders,
personal or family history of keloid or
hypertrophic scar formation, allergy to
materials used.
A: 2-octylcyanoacrylate glue (dermabond) (n=69)
B: Suture (n=64)
Wound infection not defined
Assessed daily 5-10 days, 6& 12 months post op
Assessor: plastic surgeon
Wound infection or dehiscence:
None
Cosmetic outcome (1-10 score assigned by blinded
plastic surgeon): 8.7 in A vs. 8.6 in B, NS (no SDs given)
Baseline comparability: yes
Loss to follow-up: 16.5%
Funding:
Not stated
RCT
Length of follow up: 1 yr
Blinding of outcome assessors: yes for
cosmetic appearance
Power calculation: no
Surgical site infection: full guideline DRAFT (April 2006)
Page 450 of 599
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Study
Gislason
1995
Norway
Trial Participants
Inclusion: 599 adults having major
operations for gastrointestinal
conditions
Exclusion: Urological, gynaecological
and minor general surgical operations;
laparotomy in last 3 months
Interventions
A: Continuous mass polyglyconate (Maxon) double
suture with loop (n=203)
B: Continuous mass polyglactin 910 (Vicryl) (n=199)
C: Interrupted polyglactin 910 (layered for transverse and
mass for midline incisions) (n=197)
Baseline comparability: yes
Loss to follow-up: 17.5%RCT
Length of follow up: 1 yr
Blinding of outcome assessors: yes
Power calculation: not stated
Greene
1999
20 adult patients requiring bilateral
blepharoplasty for functional or
aesthetic indications. Division of
Otolaryngology - Head and Neck
Surgery, Plastic and Reconstructive
Surgery, Standford University Medical
Centre and Palo Alto Veterans
Healthcare System, Palo Alto,
California, and Department of
Otolaryngology - Head and Neck
Surgery, Cleveland Clinic Florida,
Naples, USA. No specific exclusion
criteria are described.
Outcome measures & Results
Wound infection defined
Assessed at: not stated
Assessor: not stated
Wound infections (inflammation or discharge or both,
confirmed by culture, or abscess [wound requires
opening]):
40/199 (20%) in A versus 44/384 (11.4%) in B and C
combined, p=0.015
Burst abdomen (wound dehiscence):
8/197 (4%) in A versus 3 (2%) in B versus 3 (2%) in C,
NS
One upper eye lid with octyl-2-cyanoacrylate
(Dermabond®, Ethicon Inc, a Johnson & Johnson
company, Somerville, New Jersey, USA) and other eyelid
closed with 6.0 suture (10 fast-absorbing gut or 10
polypropylene, Prolene, Ethicon Inc, a Johnson &
Johnson company, Somerville, New Jersey, USA).
Blepharoplasties were closed on the tissue adhesive side
by using Castroviejo forceps to approximate the skin
edges in 15 patients and by using 3 - 4 sutures as
handles to facilitate apposition and eversion of edges in 5
patients.
Incisional hernia at 1 yr:
19/164 (12%) in A versus 9/163 (6%) in B versus 7/164
(4%) in C [16/327 (5%) in B and C combined], p=0.02
Wound infection defined as: not defined
Assessed at 1,2 &4 weeks post op
Assessor: physician
Dehiscence, infection, patient satisfaction, surgeon
satisfaction and cosmetic appearance at 1, 2, and 4
weeks. Time required for incision closure and allergic
reaction were also recorded although these outcomes
were not of interest to this review.
Notes - Cosmetic appearance data could not be used as
only up to 4 weeks.
One-month follow-up randomised splitbody design study. A blepharoplasty
model with identical skin sites on the
same patient and each patient acting
as his or her own control. No patients
lost to follow-up.
Surgical site infection: full guideline DRAFT (April 2006)
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Study
Study:
Grgić 2002
Setting:
Croatia
Centres:
Single
Years: no
details
Sample
size: 50
Study: Gys
19897
Setting:
Belgium
Centres:
Single
Years: May
1986 to
January
1987
Sample
size: 167
Trial Participants
Population: consecutive patients with
head & neck tumours requiring surgical
resection.
Exclusion : not stated
Interventions
Skin Staplers (Proximate Plus MD35 Wide)
(n=25)
Interrupted Sutures (3-0 monofilament nylon- Ethicon)
(n=25)
Outcome measures & Results
Wound Infection not defined
Assessed at : not stated
Healing & cosmesis assessed at 6 weeks post op.
Assessor: not stated
Type of wound: head & neck
Age: not stated
Staples & sutures removed at 7 days post op.
Study duration: not stated.
Baseline comparability: no details
Population: Consecutive patients
undergoing elective or emergency
laparotomy
Polyglyconate (Maxon) absorbable synthetic
monofilament
(n=65)
Type of wound: Colo-rectal=33.3%,
pancreaticobiliary=30.3%,
gastric=21.2%, vascular=4.5%,
other=10.6%
Age: Mean 62.5 years
Baseline comparability: States
balanced groups but slightly higher
proportion of patients with risk factors in
PA group (malignancy, obesity, shock
and dirty wounds), only reported for
evaluable population
Polyamide (Ethilon) a non-absorbable synthetic
monofilament
(n=67)
Numbers per group only reported for patients evaluated
(79% of randomised sample)
Continuous layered closure technique of closing
peritoneum with No 0, and musculoaponeurotic layer with
No 1, skin closed with 2/0 vertical mattress sutures
except if contaminated, when skin closed partially to
enable secondary healing
Study duration: 1 year
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes: Closure time, wound healing, cosmesis,
wound complications (infection, dehiscence, allergic
reaction) cost.
SSI rate: none
Wound dehiscence: none
Closure time: stapling was faster than suturing(P<0.001)
Cosmesis: No statistical difference between groups.
Cost: no significant difference in cost of products.
Calculations including closure time saving favours
staplers.
Wound Infection defined as: purulent discharge confirmed
by bacteriological growth
Assessed at : observed daily as inpatient, reviewed at
1,6 & 12 months
Assessor: not stated
Outcomes: Wound infection, incisional hernia,
dehiscence.
SSI rate:14/67 PA
10/65 PG
No statistically significant difference.
Incisional hernia within 1 yr of surgery: 4/64PA, 4/65 PG
No statistically significant difference.
Wound dehiscence: 2/67 PA, 1/65 PG
Mortality: 13/167 no details given
Page 452 of 599
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Study
Harvey
1986
Trial Participants
Inclusion: 20 patients with bilateral
varicose veins
Exclusion: Not stated
Interventions
A: 1 limb closed with staples
B: 1 limb closed with sutures
Ireland
Baseline comparability: each patient
own control
Loss to follow-up: Not stated RCT
Length of follow up: 1 month
Blinding of outcome assessors: no
Power calculation: no - underpowered
Hiramatsu
1998
Japan
Inclusion: 59 patients with biliary tract
carcinoma having liver and extrahepatic
bile duct resection, mean age 63yr
Exclusion: Liver metastases at surgery
or peritoneal dissemination
Outcome measures & Results
Wound infection defined as: redness, necrosis & infection
score(0=absent, 1=present)
Assessed at: 2-5 days post op & at out patient follow up,
time not stated
Assessor: not stated
Infection:
1/20 in each group
A: Sealed technique: povidone-iodine gel administered to
subcutaneous tissue & then continuous suture (n=31)
B: Open: wound treated with wound absorbent towels
(n=28)
Baseline comparability: yes
Loss to follow-up: not statedRCT
Length of follow up: 30 days
Blinding of outcome assessors: not
stated
Power calculation: no
Surgical site infection: full guideline DRAFT (April 2006)
Pain on removal (visual analogue scale,SDs and range
not specified):
29 in A versus 17 in B, NS
Wound infection defined
Assessed at: up to 30 days post op
Assessor: not stated
Wound infection (spontaneous or surgically released
purulent discharge with positive cultures):
5 (16%) in A versus 13 (46%) in B, p<0.05
Deaths: 1 in each group within 30 days; total procedurerelated deaths 3 (10%) in A versus 2 (7%) in B ( Death
from liver failure – condition related rather than
procedure)
Page 453 of 599
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Study
Hsiao
8
2000
Setting:
Taiwan
Centres:
Single
Years:
October
1993 to
August
1996
Sample
size: 340
Trial Participants
Population: Patients undergoing
elective laparotomy, emergency
surgical procedures were excluded,
also patients with laparotomy in
previous 3 months and with previous
incisional hernia
Type of wound: Upper GI tract=16.5%
Hepatopancreatobiliary=64.4%
Lower GI tract=14.4%
Vascular=2.3%
Other=2.3%
Age: Mean 60 years
Baseline comparability: States
balanced for age, sex, BMI, surgical
site, incision type, malignancy , though
imbalance in numbers randomised
Study:
Jallali
2004
Population:consecutive patients
requiring laparoscopic
cholycystectomy.
Setting: UK
Exclusion:
Age range:
Centres:
Single
Years:
October
2002 –
March 2004
Baseline comparability: Baseline
characteristics were comparable.
Patients in the tissue adhesive group
were younger than suture group(36yrs
vs 56yrs)
Interventions
Early-absorbable multi-filament suture polyglactin 910
(Vicryl size 0; Ethicon)
(n=184)
Late-absorbable monofilament suture polydioxanone loop
suture (PDS II size 0; Ethicon)
(n=156)
Overall 93% completed
Fascial closure with a single layer continuous suture
technique, 1.5 cm apart at least 1.5 cm from wound edge
with 1.0 cm stitch included in every third or fourth
application, prophylactic antibiotics in all patients. Same
surgeon carried out all surgery
Study duration: 24 months
1. Subcuticular 3/0 polydiaxonone (Vicryl)
(n=13- 51 wounds)
2. 2-octylcyanoacrylate (Dermabond)
( n=12-48)
Outcome measures & Results
Wound Infection defined as: purulent discharge, fever,
raised white bllod cell count
Assessed at: up to 4 weeks post op.
Assessor: not stated
Outcomes: Incisional hernia defined as a bulge, a visible
and palpable defect in the fascia, a protrusion in the
wound when the patient was examined in horizontal and
vertical position; wound infection, mortality rate
SSI rate: 9/184 Polyglactin 910
5/156 Polydioxanone loop
No significant difference.
Wound dehiscence: none stated
Mortality: 23/340 ( 17/23 died of advanced
malignancy,5/23 died of liver cirrhosis with oesophageal
varicies)
Wound Infection not defined
Assessed at: 6-8 weeks post op.
Assessor: plastic surgeon blind to closure method
Outcomes: Closure time, wound complications, cosmesis,
All patients received 2/0 polybutylate coated
polyester(Ethibond) to close the linea alba under the
epigastric & umbilical ports.
SSI: none
Closure time: Dermabond significantly faster than
Vicryl.(P= 0.03)
Cosmesis: assessed at 6-8 weeks using Hollander wound
evaluation scale.
No significant difference (P=0.25)
Mortality: not stated
Sample
size: 25
Surgical site infection: full guideline DRAFT (April 2006)
Page 454 of 599
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Study
Johnson
1997
Trial Participants
Inclusion: 242 patients with sternal and
saphenous vein harvest wounds for
clean incisions for coronary artery
bypass operations had half of each
wound (upper or lower) closed by each
method; mean age 64.7 yr
Exclusion: Emergency operations
Interventions
A: Staples
B: Intradermal sutures
Wound infection (purulent drainage, antibiotic therapy or
debridement):
Leg wounds:
46 (8.9%) in A versus48 (9.3%) in B, p=0.99
Sternal wounds:
12 (2.5%) in A versus2 (0.4%) in B, p stated to be 0.061
in table and 0.128 in abstract
Baseline comparability:
Loss to follow-up: 17 patients (9 died, 2
not closed according to protocol, 6 did
not return for follow up)RCT
Length of follow up: 3-4 weeks
Blinding of outcome assessors: No
Power calculation: yes
Study:
Karabay
2005
Setting:
Turkey
Centres:
Single
Years:
October
2002 –
March 2004
Sample
size: 100
Patient preference (each patient own control): sutures
favoured over staples among patients who noted a
difference between the two methods of closure and also
expressed a preference (sternal 75.6%, leg 74.6%)
Population:consecutive patients
requiring open –heart surgery.
Transcutaneous suture technique (TC)
(n= 50, 31 male, 19, female)
Exclusion: patients having
immunosuppressant or steroid therapy;
insulin dependent diabetes mellitus;
body mass index greater than 30
Intracutaneous suturetechnique (IC)
(n= 50, 38 male, 12 female)
Age range: 19-82 yrs
Baseline comparability: Baseline
characteristics were comparable.
Higher proportion of patients with non
insulin diabetes mellitus in IC group
(22/50) compared to TC group(13/50).
Outcome measures & Results
Wound infection defined
Assessed at: discharge, 1 week post discharge & 3
weeks post op.
Assessor: 1 of 3 doctors blind to closure technique.
Surgical procedures: 91 coronary artery bypass grafting,
2 aortic valve replacements, 2 mitral valve replacements,
1 tricuspid repair, 1 aortic&mitral valve replacements, 2
primary secundum atrial septal defect repairs, 1 cardiac
cyst excision.
In all patients the sternum was closed with steel wires
and 2 layers of polyglactin 910 suture were used for
closure of subcutaneous tissues.
All patients received 1-g dose of IV antibiotic 30 mins
prior to surgery & 8hrly post op until drains were
removed.
Surgical site infection: full guideline DRAFT (April 2006)
Figures do not appear to match between text and
abstract
Wound infection defined as: Wound Score ( 0 -7
erthythema, oedema, increased pain, haemo-serous
discharge, purulent discharge )
Deep sternal infection: positive wound or blood
cultures,fever above 38˚C or strenal instability.
Assessed at: daily for 5 days, at 14 days & 6 weekls post
op.
Assessor: surgeon who performed surgery
Outcomes: Superficial & deep sternal wound infection,
pathological agents, therapy, cosmesis, risk factors.
SSI rates:
Early wound infection: 8/50 IC
1/50 TC
Significant (P=0.016)
Late wound infection: none.
Page 455 of 599
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Incidence of wound infection higher in those with diabetes
in IC group compared to those with diabetes in TC group.
P=0.007
Cosmesis: assessed at 6 weeks by patients & surgeon
using score of 1-10 with 10 being best.
no significant difference between groups.
Conclusion: The use of TC suture techniques to close
sternal skin provides better protection against the risk of
superficial infection than IC suture techniques.
Keng1989
43 patients requiring 46 groin incisions
(inguinal hernia, femoral hernia,
sapheno ligations, testicular operations
and lymph-node biopsies). Skin
incisions were closed with either
Histoacryl tissue adhesive or dexon
subcuticular suture. In the three
bilateral operations the left side was
closed with Histoacryl and the right with
dexon. Burton General Hospital,
Burton-on-Trent, UK. Exclusion criteria
were not stated.
Dexon suture on straight needle using anchoring knot
both ends or opposing the wound with forceps and
Histoacryl
Mortality: 4 early deaths were observed. Excluded from
study.
. Wound infection defined as: pus &/or open wound
Assessed at 7days & 1 month post op
Assessor: not stated
Infection, inflammation, Cosmetic appearance, wound
closing time, wound comfort and haematoma.
Notes - Cosmetic appearance not used as only evaluated
up to 4 weeks.
Seven-month follow-up randomised
parallel group study. Three patients lost
to follow-up: one from the suture group
and two from the tissue adhesive
group.
Surgical site infection: full guideline DRAFT (April 2006)
Page 456 of 599
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Study
Khammash
1994
Trial Participants
Inclusion: 80 patients with gangrenous
or perforated appendicitis
Exclusion: Not stated
Kuwait
Interventions
A: Delayed skin closure – wound inspected on 3rd postth
operative day; if clean, closed; if in doubt, delayed to 4
th
or 5 day; if infected, left open (n=40)
B: Primary skin closure (n=40)
Baseline comparability: yes
Loss to follow-up: Not stated RCT
Length of follow up: 5 weeks
Korenkov
2002
Germany
Inclusion: 160 patients with simple
(n=100; hernia < 10cm diameter;
surgery for 1st or 2nd time) or complex
(n=60; hernia >10cm or re-recurrence)
incisional hernias
Exclusion: Contraindications for
laparotomy or laparoscopy
A: Suture repair (n=33 simple hernias; not considered
suitable for complex hernias)
B: Autodermal skin graft (hernioplasty) (n=28 simple + 29
complex)
C: Onlay (internal) polypropylene mesh repair (n=39
simple + 31 complex)
Baseline comparability: yes
Loss to follow-up: 12.5%RCT
Length of follow up: Mean 16 months;
at least 9 months in 83%
Blinding of outcome assessors: no
Power calculation: not stated
Outcome measures & Results
Wound infection defined as: confirmed positive culture &
sensitivity specimen.
Assessed at: Group A – 3 days post op. If clean wound
th
sutured. If not clean reassessd 4-5 day. All groups -7-10
days, weekly for 1 month
Assessor: not stated
Wound infection (collection of pus or turbid fluid):
9 in A (22.5%) versus 4 (10%) in B , NS
Wound infection not specifically defined included in
wound healing disorders as events requiring opening of
wound.
Assessed at: not stated; Assessor: not stated
st
Infection in 1 10 days:
Simple:
0/33 in A versus 2/28 in B versus 4/39 in C
Complex:
5/29 in B versus 2 in C [A not applicable]
Hernia recurrence:
Simple:
4/33 in A versus 4/28 in B versus 3/39 in C
Complex:
3/29 in B versus 3/31 in C [A not applicable]
Hospital stay (median):
Simple:
6 in A versus 7 in B versus 7 in C, NS
Complex:
7 in B versus 8 in C [A not applicable], NS
Pain (yes or no):
Simple:
4/30 in A versus 4/28 in B versus 16/38 in C, p=0.01
Complex:
5/27 in B versus 15/30 in C [A not applicable], p=0.03
Surgical site infection: full guideline DRAFT (April 2006)
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Study
Krukowski
19879
Setting: UK
Centres:
Presumed
single
Years: dns
Sample
size: 757
Study:
Leaper
1985a10
Trial Participants
Population: All patients undergoing
elective or emergency laparotomy
through a midline vertical incision under
the care of two consultants, patients
undergoing incisional hernia repair
excluded
Type of wound: as above
Age: 49% <60 years
Baseline comparability: balanced for
age, sex, type of operation and degree
of contamination
Years: dns
Sample
size: 95
patients
with 111
wounds
Polypropylene (PPL) 4-metric
(n=383; 77.0% completed)
Abdominal wall sutured with tension-free continuous
mass closure technique using 50 mm reverse cutting
needle, knots buried deep to linea alba. Skin closure with
interrupted monofilament polyamide mattress sutures
removed day 10,
Study duration: 1 year
Population: Patients undergoing
elective inguinal surgery (hernia or
sapheno-femoral ligation) under care of
one surgeon
Setting: UK
Centres:
Presumed
single
Interventions
Polydioxanone (PDX) 4-metric
(n=374; 76.2% completed)
Type of wound: hernia=48.6%,
veins=51.4%
Age: Mean 47 years
Baseline comparability: no imbalances
reported
Subcuticular 2/0 polypropylene (Prolene)
(n=54; 88.8% completed)
Polydioxanone (PDX)
(n=57; 85.9% completed)
Suture ends loosely tied over wound after insertion, same
skin preparation used throughout, subcutaneous fat layer
closed with 3/0 continuous chromic catgut, each wound
covered with Op-site, wounds left undisturbed until 7th
day, then prolene removed but PDX clipped flush with
skin
Study duration: 6 months
Surgical site infection: full guideline DRAFT (April 2006)
Outcome measures & Results
Wound Infection defined.
Assessed at 4-6 weeks post discharge
Assessor: not stated
Outcomes: Wound infection defined as discharge of pus
from wound or growth of a pathogenic organism from
serous or sanguineous discharge, or any reported
discharge from the wound, assessed at 4-6 weeks after
discharge from hospital; dehiscence, incisional hernia,
pain
SSI rate: 13/374 PDX
27/383 PPL
Significance: P<0.05
Wound dehiscence: 1 in each group
Mortality: 38 patients died before 4 week follow up. A
further 95 patients died within 12 months of surgery.
Wound infection defined as: persistent superficial cellulitis
or induration lasting beyond 7th post-op day, meaningful
if antibiotics prescribed, spontaneous discharge of pus or
wound required to be opened
Assessed: 7 days, 6 weeks& 6 months post op
Assessor: not stated, included GP & patient recall.
Outcomes: Wound infection; wound appearance at 6
weeks and 6 months
SSI rate:9/54 Prolene
10/57 PDS
No significant difference.
Wound dehiscence: none stated
Mortality: none stated
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Study
Leaper
11
1985b
Trial Participants
Population: Patients with major
laparotomy wounds, midline or
transverse
Setting: UK
Centres:
Two
centres
Years: dns
Type of wound: gastric=16.1%,
pancreatico-biliary=45%, small
bowel=4.4%, colon=25.5%, other=8.8%
Age: Mean 57.7 years
Baseline comparability: demographic
details only available for study
completers
Sample
size: 233
Interventions
No 1 (BPC) polyamide (nylon)
(n=97)
Polydioxanone (PDX)
(n=107)
87.6% of randomised sample completed overall
Continuous mass technique to close abdominal wall,
midline and transverse incisions but not through scar
tissue, skin closed with continuous subcuticular 00
polypropylene suture, wound covered with Op-site
dressing, antibiotic prophylaxis if required
Study duration: 6 months
Maartense
2002
140 adult patients requiring elective
laparoscopic surgery. Patients were
excluded if they had undergone
previous laparotomy or were pregnant.
The study was undertaken at two
centres, Department of Surgery,
Academic Medical Centre, Amsterdam,
and Department of Surgery, Isala
Clinics, Zwolle, The Netherlands.
Octylcyanoacrylate (Dermabond®, Johnson & Johnson,
Amersfoot, The Netherlands) tissue adhesive versus 76
mm X 6 mm adhesive paper tape (SteriStrip®
Bioplasty/Uroplasty, Geleen, The Netherlands) versus
intracutaneous poliglecaprone (Monocryl®) 4/0, Johnson
& Johnson) interrupted sutures. 48 patients were in the
adhesive group, 42 were in the tape group and 50 were in
the suture group.
ixteen-month follow-up randomised
parallel group study. There were no
withdrawals, however seven patients
treated with paper tape and three with
tissue adhesive were converted to the
suture group.
Surgical site infection: full guideline DRAFT (April 2006)
Outcome measures & Results
Wound infection defined as: purulent discharge, systemic
symptoms causing delayed discharge)
Assessed at: daily during inpatient period up to 14 days,
6 week & 6 months at out patient
Assessor: not stated
Outcomes: Major and minor wound sepsis , incisional
hernia, dehiscence, mortality rate.
SSI rate: 9 /97 BPC (7 minor, 2 major)
18 /107 PDX (14 minor,4 major)
Not statistically significant.
Authors suggest trend towards increased infection with
synthetic sutures which are absorbed more slowly.
Mortality: 16 died before 6 months. None related to use of
suture materials used in the study.
Wound infection defined as: pus requiring surgical or
spontaneous drainage
Assessed at 10 -14days & 3 months
Assessor: surgical house officers.
Infection, cosmetic appearance, and surgeon satisfaction
at 2 weeks and 3 months, and costs. Time required for
incision closure was also recorded.
Notes - There were 43 patients and 46 wounds included.
The wounds were treated as independent data which
strictly is incorrect, however as there were only three
patients with more than one wound it will make little
difference to the conclusions so the study and data is
included.
Page 459 of 599
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Study
Maffulli
1991
Trial Participants
Inclusion: 100 patients having
arthroscopy
Exclusion: Not stated
Interventions
Arthroscopic wounds:
A: Sutured (n=47)
B: Bandaged (n=53)
Belgium
Baseline comparability: yes
Loss to follow-up: not stated RCT
Length of follow up: 12 weeks
Blinding of outcome assessors: not
stated
Power calculation: no
Magann
2002
Australia
McNeill 1986
Inclusion: 964 women having
Caesarean section with ≥2cm
subcutaneous tissue
Exclusion: Emergency operation
Baseline comparability: yes
Loss to follow-up: 26.4%RCT
Length of follow up: 6 weeks
Population: Patients undergoing
gastric surgery for morbid obesity
Setting: USA
Centres:
Presumed
single
Years: 1981
Sample size:
105
(randomised)
121(non
randomised
Type of wound: Gastric
bypass=30.5%
gastroplasty=69.5%
Age: Mean 36.5 years
Baseline comparability: weight
greater in polyglycolic group 149 (kg)
compared with 132 kg in wire group
Study duration: Mean follow-up 18.5
months
Outcome measures & Results
Wound infection not defined
Assessed at: 2& 12
weeks post op
Assessor: not stated
Superficial abscesses:
4 in A versus 1 in B, p=0.038
All skin closure with clips
Subcutaneous closure with:
A: Not closed (n=205)
B: Running suture of polyglycolic suture (n=191)
C: 7-mm closed drainage system (n=146)
Cosmetic appearance at 12 weeks (1=well-healed;
3=clearly visible scar with cross-hatching):
Mean 2.1(0.81) in A versus 1.3 (0.4) in B, p=0.031 (chi
square test – should have used non-parametric tests)
Wound infection defined as: induration, erythema,
purulent material
Assessed at: 14 & 42 days post op
Assessor: not stated
Wound infection:
14 in A versus 16 in B versus 14 in C, NS
No 28 interrupted monofilament stainless steel wire for
fascial closure, near-far, far-near placement, far were
placed 1.5 cm and near 0.5 cm deep to fascial edge,
each suture advanced 1.5 cm along wound edge, three
throws for each knot, care taken to avoid kinks in the wire
(n=54; 98% completed)
Continuous closure with No 2 polyglycolic acid suture
coated with polaxamer 188, for fascial closure, sutures
placed 1.5 cm increments, four throws used for each
knot, approximately three sutures needed for length of
incision
(n=51; 98% completed)
All wounds closed by house officers with three or more
years of training under direct supervision of attending
surgeon, prophylactic antibiotics given to all patients, no
subcutaneous sutures used
Surgical site infection: full guideline DRAFT (April 2006)
Wound infection not defined
Assessed at: unclear between 6-14 days post op.
Assessor: not stated
Outcomes: Wound complications: hernia, dehiscence,
infection
SSI rates: 1/54 No 28 interrupted monofilament stainless
steel wire group
2/51 polyglycolic acid suture /polaxamer 188
Dehiscence: 1/54;
0/51
Incisional hernia: 5 in each group.
SSI rates in the non randomised group: 13 /121
Mortality: 2/105 randomised + 2/121 non randomised
cases(1.8%). No deaths attributable to closure methods.
Page 460 of 599
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Study
Mullen
1999
USA
Trial Participants
Inclusion:80 patients (3 later
excluded) undergoing elective
coronary artery bypass surgery
Exclusion: Insertion of a drain, intraaortic balloon pump in index limb, or
inability to complete follow up
Interventions
A: Staples, close immediately (n=20)
B: Staples, close after protamine administration (n=20)
C: Subcuticular sutures, close immediately (n=19)
D: Subcuticular sutures, close after protamine
administration (n=18)
Baseline comparability: yes
Loss to follow-up: 3.75%RCT
Length of follow up: 6-8 weeks
Blinding of outcome assessors: Not
stated
Power calculation: No underpowered
Murphy 1995
Population: Patients undergoing
bypass surgery with a groin incision
Subcuticular Maxon
(n=41 wounds; 100% completed)
Setting:
Ireland
Type of wound: Aorto-femoral
bypass=25%
femorodistal bypass=75%
Continuous nylon over and over technique
(n=38 wounds; 100% completed)
Centres:
Presumed
single
Years: dns
Sample size:
114 with 173
wounds
Age: Mean 67 years
Baseline comparability: no
imbalances noted
Interrupted nylon
(n=45 wounds; 100% completed)
Clips
(n=49 wounds; 100% completed)
Subcutaneous tissues closed with 3/0 Maxon in two
layers to leave skin edges to be closed by four
interventions
Study duration: 14 days
Surgical site infection: full guideline DRAFT (April 2006)
Outcome measures & Results
Minor leg wound infection rate (erythema+ one of: fever
38.5C, raised WBC >12x109/L: or purulent discharge):
A: 3 (15%)
B: 3 (15%)
C: 1 (5.3%)
D: 0
Major leg wound infection rate (infection requiring i.v.
antibiotics or surgical therapy, prolonging hospital stay or
requiring readmission):
A: 0
B: 0
C: 0
D: 2 (10.5%)
Assessed daily during inpatient stay by phone & 6-8
weeks post discharge
Assessor: not stated
Wound infection defined as positive cultures.
Assessed at: alternate days up to 14 days post op
Assessor: not stated
Outcomes: Infection confirmed by bacteriological culture,
dehiscence, cost of suture material
SSI rate:1/41 Subcut Maxon
1/38 Cont. Nylon
2/45 Interup. Nylon
1/49 Clips
No significant difference between groups.
13 wounds showed local signs of infection but had
negative cultures.
Dehiscence: none stated
Mortality: not stated
Page 461 of 599
DRAFT FOR CONSULTATION
Study
Murphy 2004
Trial Participants
Inclusion: 60 patients undergoing
routine clean orthopaedic procedures
Exclusion: Not stated
Interventions
A: Clips (n=31)
B: Sutures (n=29)
Baseline comparability: Not stated
Loss to follow-up: Not stated RCT
Length of follow up: 13 days
Blinding of outcome assessors: No
Power calculation: no Underpowered
Study:
Mylonas
199114
Population: Patients under the care
of one consultant undergoing a
neurosurgical operation, emergency
and elective, clean and contaminated
Interrupted 3/0 neurilon used throughout with exception of
muscle layer in posterior spinal operations where 1
neurilon was used
(n=50; % completed)
Type of wound: 91% clean
craniotomy=42%
shunt=16%
spinal=16%
other=25%
Continuous 12/0 polydioxanone (PDS) absorbable
monofilament and subcuticular vicryl for skin, Continuous
2/0 used throughout with exception of: dura repaired with
4/0 PDS, continuous 1 PDS used for muscle layer of
posterior spinal procedures
(n=49; % completed)
Setting: UK
Centres:
Presumed
single
Years:
October 1989
to February
1990
Sample size:
99
Age: Mean 41.2 years
Baseline comparability: States well
balanced, more patients in neurilon
group on steroids (31 vs. 18), and
more females
Study duration: 3 months
Surgical site infection: full guideline DRAFT (April 2006)
Outcome measures & Results
Wound infection (erythema plus discharge, wound
required opening or antibiotics):
1 (3.2%) in A versus 1 (3.4%) in B, NS
Dehiscence:
1 (3.2%) in A versus 1 (3.4%) in B, NS
Assessed at 13 days, further assessment not stated
Assessor: surgeon
Cosmesis (scale 1-4; 1=good) NS
Pain on removal (visual analogue score):
Clip removal less painful (mean VAS 11.5 SEM 1.1 in A
versus 24.2 SEM 3.3 in B, p=0.001)
Wound infection not defined
Assessed at: unclear – at time of discharge & at 3 months
Assessor: unclear but included participants’ GP’s.
Outcomes: Wound complications: infection and
dehiscence
SSI rates: 1/49 PDS
3/50 /Neurilon
No significant difference
Dehiscence: 1/49 PDS
1/50 /Neurilon
No significant difference
Mortality: not stated.
Page 462 of 599
DRAFT FOR CONSULTATION
Study
Nasir
2001
Trial Participants
Inclusion: 100 patients having
laparotomy through midline incision
Exclusion: not stated
Interventions
A: Continuous double loop closure (n=50)
B: Continuous mass closure (n=50)
Both arms used polypropylene
Outcome measures & Results
Wound infection not defined
Assessed at: 5-7, 21 & 42 days post op
Assessor: not stated
Iraq
Negri
2002
Baseline comparability: Unclear –
patients having emergency
operations were more likely to be in
group B (54% versus 46% in A, not
clear how significant this is; not
adjusted for in analysis)
Loss to follow-up: noneRCT
Length of follow up: 6 weeks
Blinding of outcome assessors: not
stated
Power calculation: not stated
Inclusion: 1000 patients requiring
cardiac surgery
Exclusion: Not stated
Infection:
6 (12%) in A versus 9 (18%) in B
Wound dehiscence:
None in A versus 4 (8%) in B
A: Nitillium clips for bone approximation (n=500)
B: Standard closure with sternal wires (n=500)
Wound infection defined
Assessed at: 6 weeks post op
Assessor: not stated
Italy
Baseline comparability: yes
Loss to follow-up: Not stated RCT
Length of follow up: Not stated
Blinding of outcome assessors: Not
stated
Power calculation: Not stated
Sternal wound infection:
12 (2.4%) in A versus 15 (3%) in B, NS
Sternal wound dehiscence
1 (0.2%) in A versus 14 (2.8%) in B, p=0.002
Death: 0 in A versus 1 (0.2%) in B, NS
Surgical site infection: full guideline DRAFT (April 2006)
Page 463 of 599
DRAFT FOR CONSULTATION
Study
Niggebrugge
1999
Denmark
Trial Participants
Inclusion: 390 patients undergoing
midline-laparotomy wound closure
Exclusion: Age 15 or less;
laparotomy in previous 3 months
Interventions
A: Continuous Running Suture (CRS) (n=204)
B: Continuous double-loop closure (CDLC) (n=186)
Wound dehiscence:
4 (2.0%) in A versus 7 (3.8%) in B, NS
Baseline comparability: yes except
23% emergency in A versus 33% in
B, p=0.02; accounted for by separate
analyses for elective and emergency
Loss to follow-up: none
Ong
2002
Singapore
Funding:
Ethicon
Outcome measures & Results
Wound infection (purulent discharge or positive cultures):
13 (6.4%) in A versus 17 (9.1%) in B, NS
Severe wound pain (≥7 on 0-10 scale):
Day 2: 114/197 (58%) in A versus 61/169 (36%) in B,
p<0.0001
Day 4: 55/190 (29%) in A versus 28/165 (17%) in B,
p=0.01
Day 6: 30/188 (16%) in A versus 13/144 (9%), p=0.04
Day 8: NS, no details given
A: 2-octylcyanoacrylate glue (n=26)
B: Sutures (n=33)
Inclusion: 59 children having
herniotomies (mean age 4.5 yr)
Exclusion: Neonates or children
allergic to glue
Mortality within 30 days:
17 (8.3%) in A versus 39 (21.0%) in B, p=0.0004
[Emergency surgery: 7/47 (15% in A versus 22/62 (35%)
in B, p=0.02; elective surgery: 10/157 (6%) in A versus
17/124 (4%) in B, p=0.04]
Wound infection defined as: not stated
Assessed at 14-21 days & 3 months
Assessor: independent nurse observer.
Wound dehiscence: none in either group
Wound infection: none in either group
Baseline comparability: yes
Length of follow up: 2-3 weeks;
originally planned to review at 3
months but only 9/59 patients
returned
Blinding of outcome assessors: yes
Surgical site infection: full guideline DRAFT (April 2006)
Cosmetic appearance: 2 patients in each group had suboptimal outcome (5/6 where 6=full score= acceptable
outcome)
Parent satisfaction: no difference between groups (glue
78mm +/-19mm vs. suture 81+/-15mm on 100mm visual
analogue scale)
Page 464 of 599
DRAFT FOR CONSULTATION
Study
Onwuanyi
1990
Nigeria
Trial Participants
Inclusion: 100 patients having
appendicectomy (90 emergencies)
Exclusion: Concurrent illnesses (e.g.
diabetes)
Interventions
A: Interrupted transdermal technique (n=50)
B: Subcuticular continuous technique (n=50)
Both groups had nylon sutures
Outcome measures & Results
Wound infection not defined.
Assessed at: days 3,7 & 14 & 6 months post op
Assessor: not stated
Wound infection (at 2 weeks):
3 (6%) in A versus 3 (6%) in B, NS
Baseline comparability: yes
Loss to follow-up: 14%RCT
Length of follow up: 6 months
Blinding of outcome assessors: not
stated
Power calculation: not stated
Wound abscess: None
Persistent pain at 6 months:
2/42 in A versus 0/44 in B
Mean cost of suture per wound:
16 Naira in A versus 8 Naira in B, p<0.025 (no SDs
given)
Study: Orr
200315
Setting: USA
Centres: 9
Years: May
1999 to June
2000
Sample size:
203
Population: High risk factors for poor
wound outcome with abdominal
incisions, age at least 18 years,
evidence of compromised wound
healing due to at least 1 of following:
age > 70 years, obesity, cancer,
diabetes, COPD, chronic steroid use,
altered nutritional status, ascites,
renal insufficiency, jaundice, prior
radiation to surgical site, prior
transverse incision crossing study
incision
Type of wound: abdominal
malignancy=70%, others=30%
Age: Mean 55 years; range 21-87
years
No 1 long-term absorbable multifilament suture poly(Llactide/glycolide) (PLG)
(n=104)
Permanent monofilament (No 1) polypropylene
(n=97)
Overall 99% completed
Continuous fascial closure for both with strict peroperative management protocol: no more than 3 doses
prophylactic antibiotics, sutures spaced at least 1.5 cm
from fascial edge and 1.5 cm apart, no subcutaneous
closure, no drains
Study duration: 6 months
Surgical site infection: full guideline DRAFT (April 2006)
Mean length of stay: 7 days in A versus 6.9 in B (SDs not
given)
Wound infection: not defined
Assessed at: It is unclear when infections were
measured, but complications were recorded in the
immediate postoperative period as well as at scheduled
visits (4-6 weeks, 6 months).
Assessor: not stated
Outcomes: Wound outcomes not defined and suture
handling characteristics.
SSI rates: 8/104 PLG
6/97 No1ppp.
No significant difference( P=0.75).
Dehiscence: 4/104 PLG
10/97 No1ppp
No significant difference( P=0.09).
Mortality: not stated.
Page 465 of 599
DRAFT FOR CONSULTATION
Study
Orr
1990
USA
Osther 1995
Setting:
Denmark
Centres:
Presumed
single
Years: March
1990 to
December
1991
Sample size:
204
Trial Participants
Inclusion: 404 low risk women having
abdominal gynaecological
procedures
Exclusion: High risk (e.g. active
infection plus cancer plus previous
radiation); vaginal operation
Baseline comparability: yes
Loss to follow-up: NoneRCT
Length of follow up: 6 months
Blinding of outcome assessors: not
stated
Power calculation: not stated
Population: People with suspected
impaired wound healing undergoing
elective or emergency laparotomy,
impaired wound healing included one
or more of following criteria: age > 70
years, COPD for at least 10 years,
intra-abdominal malignancy or
diffuse peritonitis, incisions through
previous scar excluded
Type of wound: dns
Age: Median 75 years (Dexon) and
77 years (Maxon)
Baseline comparability: balanced for
age, sex, type of incision and
operation, risk factors, presence of
malignancy or corticosteroid use
Interventions
A: Continuous closure of fascia (n=201)
B: Interrupted closure of fascia (n=201)
Outcome measures & Results
Wound infection not defined
Assessed at: daily as inpatient, 4 & 24 weeks post
discharge
Assessor: Doctor
Infection or seroma:
9/201 (4.5%) in A versus 4/201 (2.0%) in B, NS
Hernia:
3/201 (1.5%) in A versus 2/201 (1.0%) in B, NS
Dehiscence: None
Early absorbable multifilament polyglycolic acid sutures
(Dexon 0/0) for fascial closure
(n=100; 84% completed 3 months, 70% 12 months)
Late absorbable monofilament polyglyconate sutures
(Maxon)
(n=104; 74% completed 3 months, 64.4% completed 12
months)
Fascial closure following abdominal surgery, sutures
placed 1.5 cm from fascial margins with 1 cm between
each stitch as a simple interrupted suture, subcutaneous
tissues not closed, skin closed with interrupted nylon 3/0,
foe elective surgery prophylactic antibiotics used routinely
for clean-contaminated operations, antibiotics used for 3
days post-op for dirty surgery, operations performed by
several surgeons equally distributed between groups
Wound infection defined as purulent discharge leading to
surgical drainage
Assessed at: the time of measurement was not stated,
but is described as ‘early complications’
Assessor: not stated
Outcomes: Wound complications including wound
infection; incisional hernia and fascial disruption when reoperation necessary, mortality rate.
SSI incidence: 16% Dexon
7% Maxon
Significant difference( P=0.04).
Incisional hernia: incidence was not significantly different
between suture groups.
26% of patients with wound infection later developed
incisional hernia vs 9% of those without wound infection
(P=0.01)
Study duration: 12 months
Mortality: 32 deaths ( 16 in first 14 days post op. 16 died
more than 14 days post op. 3 of these patients developed
wound infection before death)
Surgical site infection: full guideline DRAFT (April 2006)
Page 466 of 599
DRAFT FOR CONSULTATION
Study
Ozturan 2001
Trial Participants
101 patients requiring rhinoplasty or
septorhinoplasty were entered to the
study. Patients were excluded if they
had a history of peripheral vascular
disease, diabetes mellitus, clotting
disorder, keloid or hypertrophy, or
allergy to cyanoacrylate or
formaldehyde. Inonu University
Hospital, Turkey.
Ranaboldo
1992
UK
Three-month follow-up randomised,
parallel group study. There were no
withdrawals.
Baseline comparability: yes
Loss to follow-up: Not stated
Inclusion: 48 patients with midline
abdominal wounds, mean age 65 yr
Exclusion: Not stated
RCT
Length of follow up: 1 month
Blinding of outcome assessors: yes
for visual appearance at 1 month
Power calculation: no –
underpowered
Interventions
Butylcyanoacrylate (LiquiBand. MedLogic Global Ltd,
Plymouth, Devon, UK) tissue adhesive versus 6.0
polypropylene sutures for columellar skin closure after the
majority of the tension had been taken up using 5.0
chromic catgut. 34 patients were in the adhesive group
and 67 patients were in the suture group.
Outcome measures & Results
Wound infection defined as: not stated
st
Assessed: weekly for 1 4 weeks post op, then at 8 & 12
weeks.
Assessor: surgeons
Dehiscence and infection at one week. Cosmesis at three
months by blinded assessment of photographs using
VAS and Hollander scale. Time required for skin closure
was also measured.
Notes – We wrote to the authors to clarify the numbers in
each group randomised by coin toss and received
confirmation that the numbers were correct. We also
received clarification that the standard deviations were
presented after the means in the results section of the
paper.
A: Staples (n=22)
B: Sutures (n=26)
Wound infection not defined
Assessed at: not stated
Assessor: not stated
Wound infection with discharge of pus:
1 in each group
Pain at 5 days (100mm visual analogue scale):
Median 28mm for staples versus 16mm for suture,
p=0.03
Wound appearance score on 5-point scale (no further
details) 4.1 in A versus 3.6 in B, NS
Cost: Mean cost per patient £7.72 for staple insertion +
£6.27 for staple removal versus £1.41 for sutures (no
SDs given)
Surgical site infection: full guideline DRAFT (April 2006)
Page 467 of 599
DRAFT FOR CONSULTATION
Study
Rink
2000
Germany
Risnes
2001
Norway
Trial Participants
Inclusion: 95 patients with infective
or malignant intra-abdominal
diseases at increased risk of wound
failure after major abdominal
operations due to co-existing
respiratory disease, emergency
operation, intra-abdominal infection,
long-term use of steroids, obesity,
malnutrition, chemotherapy,
diabetes, renal insufficiency,
previous abdominal operation.
Exclusion: Uncomplicated
appendicitis or cholecystitis; patients
with multiple injuries.
Baseline comparability: yes
Loss to follow-up: re-operation (5) or
early removal of sutures (17) or
death (5) led to removal from study
before day 12 of 27 patients
(28%)RCT
Length of follow up: 12 days
Blinding of outcome assessors: Not
stated
Power calculation: No
Inclusion: 300 patients over 16 yr
undergoing open heart surgery;
mean age 64.8 yr
Exclusion: Immunosuppressive or
steroid medication
Interventions
A: Conventional mass closure with reinforcement by wire
retention sutures for 12 days (n=44)
B: Conventional mass closure without reinforcement by
wire retention sutures (n=51)
Outcome measures & Results
Wound infection defined as: discharge from incision
(purulent/serous/sanguious)
Assessed at: not stated
Assessor: not stated
Wound dehiscence: None in group A versus 1 in group B.
Deaths: 2 in group A versus 3 in group B (p=1)
Mortality from multi organ failure due to disease, not
method of suture
Pain (0-4 scale; 0=none; 1=mild; 2=moderate; 3=severe;
4=extreme):
Day 3: Median 2 in group A versus 1 in group B; Day 6: 1
versus 0 (p=0.01 Mann-Whitney U test); Day 9: 1 versus
0; Day 12: 0 versus 0.
But 6 patients had sutures removed between day 6 and
day 9, and 10 more between day 9 and day 12; 15 of
these 16 were removed for intolerable pain.
A : Intracutaneous poliglecaprone (absorbable) sutures
(n=150)
B : Transcutaneous polyamid (non-absorbable) sutures
(n=150)
Baseline comparability: yes
Loss to follow-up: None stated RCT
Length of follow up: 6 weeks
Blinding of outcome assessors:
Unclear. Cosmetic appearance
assessed by patients; unclear who
assessed wound infection
Surgical site infection: full guideline DRAFT (April 2006)
Wound infection defined as: pus with erythemia, oedema
+/or pain
Assessed at: 3 days & 6 weeks post op
Assessor: not stated
Superficial wound infections (4 or more on scale of 0-7):
20 (13.3%) in A versus 7 (4.7%) in B, p=0.01
Deep wound infections (mediastinitis): 4 (2.7%) in A
versus 2 (1.3%) in B
Total infections:
24 (16.0%) in A versus versus 9 (6.0%) in B, p=0.007
Page 468 of 599
DRAFT FOR CONSULTATION
Cosmetic appearance at 6 weeks (1-10 scale, assessed
by patients): 8.3 in A versus 8.0 in B (no SDs given)
Deaths within 30 days of surgery: 8 (5.3%) versus 10
(6.7%), p=0.87
Risnes
2002a
Norway
Risnes
2002b
Norway
Trial one
Inclusion: 166 patients having
saphenous vein harvesting for
coronary artery bypass grafting;
mean age 68.1 yr
Exclusion: Immunosuppressive or
steroid medication
Baseline comparability: Yes
Loss to follow-up: None
RCT
Length of follow up: ‘after 6 weeks’
Blinding of outcome assessors: No;
assessed by patients
Power calculation: Yes
Trial two
Inclusion: 168 patients having
saphenous vein harvesting for
coronary artery bypass grafting;
mean age 68.1 yr
Exclusion: Immunosuppressive or
steroid medication
Trial one
A: Transcutaneous polyamid (non-absorbable) sutures
(n=85)
B: Intracutaneous poliglecaprone (absorbable) sutures
(n=81)
NB The data in this study do not appear to be consistent
between the text, the tables and the abstract.
Percentages have been recalculated using raw data
Trial one
Wound infection defined as: pus with erythemia, oedema
+/or pain
Assessed at: 6 weeks post op
Assessor: not stated
Leg wound infection rate (score of 4 or more on 0-7
scale, assessed by patient):
A: 15 (17.6%); B: 19 (23.5%), p=0.35
Cosmetic appearance at 6 weeks:
A: Mean score 8.0 on 1-10 scale; B: 8.3, p=0.35 (no SDs
given)
Trial two
A: Non-invasive surgical zipper (n=78)
B: Intracutaneous suture (n=90)
Baseline comparability: Yes
Loss to follow-up: None
Surgical site infection: full guideline DRAFT (April 2006)
Deaths: 6 (7.1%) in A versus 4 (4.9%) in B, p=0.59
Trial two
Leg wound infection rate (score of 4 or more on 0-7
scale, assessed by patient):
A: 15.3%; B: 23.3%, p=0.20
Cosmetic appearance:
A: Mean score 9.0 on 1-10 scale; B: 8.4, p=0.003 (no
SDs given)
Deaths: 5 (6.4%) in A versus 3 (3.3%) in B, p=0.59
Page 469 of 599
DRAFT FOR CONSULTATION
Study
Roolker
2002
Netherlands
Trial Participants
Inclusion: 120 patients aged over 18
yr having a hip, knee or spine
operation; mean age 47 yr
Exclusion: Not stated
Interventions
A: Zipper in 20 surgical knee wounds, 20 hip wounds and
20 orthopaedic spine wounds (n=60)
B: Intracutaneous sutures in 20 surgical knee wounds, 20
hip wounds and 20 orthopaedic spine wounds (n=60)
Baseline comparability: yes
Loss to follow-up: Not stated
Sadick 1994
Australia
Inclusion: 100 patients having
excision of benign pigmented lesions
of upper back
Exclusion: not stated
Outcome measures & Results
Infection (erythema, purulence or excessive tenderness):
2 in A vs. 0 in B, p=0.66
Wound dehiscence: 5 in A vs. 2 in B, p=0.24
Scar result rated ‘very good’ in 49 (82%) in group A vs.
51 (85%) in group B, p=0.67.
A: Conventional bi-layered technique (n=50)
B: Buried vertical mattress technique (n=50)
Baseline comparability: not stated
Loss to follow-up: not stated
Cost:
Surgeon’s time: $2 for zipper vs. $11.6 for sutures,
p=0.001
Materials: $13 for zipper vs. $8 for sutures, p=0.01.
Surgeon’s time plus cost of zipper or sutures: $15 vs.
$19.6 (no SDs given)
Infection:
3 (6%) in A vs. 2 (4%) in B, NS
Hypertrophic/keloid scar:
8 (16%) in A vs. 1 (2%) in B, p<0.031
Dehiscence:
3 (6%) in A vs. 1 (2%) in B, NS
Patient satisfaction:
44 (88%) in A vs. 48 (96%) in B, NS
Wound scar spread (>3mm):
12 (24%) in A vs. 3 (6%) in B, p<0.02
Surgical site infection: full guideline DRAFT (April 2006)
Page 470 of 599
DRAFT FOR CONSULTATION
Study
Sahlin 1993
Setting:
Sweden
Centres: 2
Years: dns
Sample size:
988
Trial Participants
Population: Patients undergoing
abdominal surgery, emergency and
elective surgery, patients requiring
muscle splitting incisions excluded
Type of wound: UGI=15%
hepatopancreatobiliary=41.5%
LGI=35.8%
Vascular=3%
other=3%
Age: Mean 58 years
Baseline comparability: none stated
though only given for study
completers
Interventions
Monofilament continuous absorbable suture for closure
of abdominal wall polyglyconate (Maxon size 0), large
bites and close stitches, beginning with a half blood knot
and ending with an Aberdeen knot
(n about 500; 345 completed)
Multifilament interrupted absorbable suture for closure of
abdominal wall polyglactin 910 (Vicryl size O), interrupted
far and near sutures and ordinary surgical knots,
considered the standard technique in the department
(n about 500; 349 completed)
Study duration: 1 year
Outcome measures & Results
Wound infection not defined
Assessed at: not stated
Assessor: not stated
Outcomes: Re-operations, incisional hernia, dehiscence,
infection, suture granuloma and other wound healing
problems at 1 year
SSI rates: 35/ 345 Maxon
37/339 Vicryl
No significant difference
Dehiscence: 4/ 345 Maxon
3/339 Vicryl
No significant difference.
Hernia: 21/ Maxon
21/ Vicryl
No significant difference
Sebesta
2003
USA
Funding:
Ethicon
Inclusion: 59 patients in whom 228
laparoscopic trocar scars were
closed
Exclusion: Wounds in both groups
that did not closely approximate
received interrupted subcutaneous
sutures
A: 2-octylcyanoacrylate glue (dermabond) (n=30 patients,
118 incisions)
B: Sutures (n=29 patients, 110 incisions)
Mortality: 79 patients died, no details given.
Wound infection defined as: not stated
Assessed: 14 days post op.
Assessor: not stated
Length of follow up: 2 weeks
Wound infection:
1 in A vs. none in B
Baseline comparability: Not stated
Loss to follow-up: Not stated
Blinding of outcome assessors: Not
stated
Surgical site infection: full guideline DRAFT (April 2006)
Page 471 of 599
DRAFT FOR CONSULTATION
Study
Shamiyeh
2001
Trial Participants
79 adult patients requiring varicose
vein surgery on the leg. Ludwick
Boltzmann Institute, Linz, Austria.
Patients were excluded if they had a
history of chronic venous
insufficiency with dermatosclerosis,
previous phlebectomies, or allergy to
plaster or octylcyanoacrylate.
Interventions
Mullerian phlebectomy creating average wound length of
five mm. Used 5 min wound compression followed by
skin closure with octylcyanoacrylate tissue adhesive or
5.0 monofilament suture or tape. A small plaster was
placed over each wound. 26 patients were in the tissue
adhesive group, 28 in the suture group, and 25 in the
tape group.
Outcome measures & Results
Wound infection defined as: not stated
Assessed: 10 days & 2weeks post op.
Assessor: not stated
Skin approximating with skin hooks and applying n-butyl
2-cyanoacrylate adhesive (Indermil)
or
suturing with 4.0 monofilament.
Wound infection:
Assessed: 7-10 days, 6,12 weeks
Assessor: Tissue viability nurse blind to closure method
All cases have local anaesthetic infiltration with or without
general anaesthesia. 20 patients were in the tissue
adhesive group and 24 were in the suture group.
Dehiscence, infection, pain on movement, cosmetic
appearance at 10 days, 2 weeks and 6 weeks.
Nine-month follow-up randomised,
parallel group study. Two patients
were lost to follow-up from the suture
group due to failure to attend and
could not be traced by mail or
phone.
Sinha 2001
Monklands
Hospital,
Airdre, UK.
50 adult patients requiring hand or
wrist surgery (carpal tunnel
syndrome, trigger finger, De
Quervain’s tenosynovitis, ganglions
of wrist and hand, and cysts of
fingers). Patients were excluded if
they required surgery for Dupuytren’s
contracture, repeat surgery or had a
history of skin allergy, keloid
formation, diabetes, or corticosteroid
use.
Surgical site infection: full guideline DRAFT (April 2006)
Wound dehiscence, infection, at 10 days and patient and
surgeon satisfaction including with cosmetic appearance
at 1 year and costs. Time required for incision closure
was also recorded although this outcome was not of
interest to this review.
Notes – We wrote to the authors to clarify the reason that
two patients were lost to follow up and also to clarify how
many patients in each group had dehiscence and
infection at 10 days. We received the clarification
required to enable us to use the data in this review.
Page 472 of 599
DRAFT FOR CONSULTATION
Study
Toriumi 1998
Trial Participants
111 patients of 1 year of age and
over requiring elective surgery for
benign skin lesions predominantly in
face and neck. Patients were
excluded if there was a history of
significant trauma, peripheral
vascular disease, diabetes mellitus,
and blood clotting disorder, keloid or
hypertrophy, known allergy to
cyanoacrylate or formaldehyde.
University of Illinois, Chicago, USA.
Interventions
Incisions with and without subcutaneous sutures and then
randomised for closure with octyl-2-cyanoacrylate or 5.0
or 6.0 nylon suture.
Outcome measures & Results
Wound infection defined as: not stated
Assessed: Dehiscence and infection were noted at 5-7
days.
Assessor: not stated
Cosmesis was noted at 90 days and 1 year. Closure time
was also recorded.
One-year follow-up randomised,
parallel group study. 11 patients
were lost to follow-up: reason for
withdrawal not stated by group.
Van den Ende
2004
The
Netherlands
Inclusion: 100 children having
herniotomies or orchidopexy
Exclusion: Not stated
A: N-butylcyanoacrylate glue (n=50; mean age 2.5 yr)
B: Sutures (n=50; mean age 3.0 yr)
Baseline comparability: yes
Loss to follow-up: None stated
Funding:
Not stated
Wound infection defined as: not stated
Assessed: 10 days & 6 weeks post op.
Assessor: not stated
Wound dehiscence: 13/50 (26%) with glue vs. 0/50 with
sutures (p<0.001)
Wound infection: 4 vs. 2 (NS)
Cosmetic appearance: Rated by doctor: mean score 7.1
with glue vs. 8.5 with suture on 1-10 scale (p<0.001)
Rated by patient/parent: 6.8 vs. 8.5 (p<0.001)
NB these figures of 8.5 in Table 1 were referred to as 8.6
in the text.
Surgical site infection: full guideline DRAFT (April 2006)
Page 473 of 599
DRAFT FOR CONSULTATION
Study
Velmahos
2002
USA
Trial Participants
Inclusion: 48 patients having
operations for colon injuries at a
trauma centre
Exclusion: Aged under 18 yr,
pregnant, operated on >6 hours after
admission or damage control
procedures with abdomen left open
Interventions
A: Primary skin closure (n=26)
B: Delayed skin closure (n=22)
Outcome measures & Results
Wound infection (pus, positive wound cultures and, if
wound closed, need for opening for drainage) :
17 (65%) in A vs. 8 (36%) in B, p=0.04
Wound dehiscence (separation of fascia):
8 (31%) in A vs. 3 (14%) in B, NS
Necrotising soft tissue infection (severe infection
spreading to soft tissues, causing necrosis and requiring
extensive debridement):
1 (4%) in A vs. 2 (9%) in B, NS
Baseline comparability: yes
Loss to follow-up: 3 (6%) re-operated
within 2 days and left with open
abdomen
Hospital stay:
17 (20) in A vs. 18 (13) in B, NS
Wetter 1991
Setting: UK
Centres:
Single
Years: 1987
to 1988
Sample size:
650
Wolterbeek
2002
The
Netherlands
Population: Patients undergoing
appendicectomy, patients
undergoing appendicectomy
incidental to another procedure
excluded
Types of wound: As above
Age: Median 18 years; range 5 to 80
years
Baseline comparability: Balanced for
age, sex, antibiotic prophylaxis,
surgeon performing surgery,
histological diagnosis and operative
site condition
Inclusion: 170 patients with femoropopliteal or femoro-tibial bypass
Exclusion:
1/0 polyglycolic acid (Dexon) used for all sutures and 3/0
polyglycolic acid for subcuticular skin closure
(n=308)
1/0 chromic catgut for all sutures and 3/0 mono filament
nylon used for subcuticular skin sutures (n=307)
95% completed overall
Operative technique similar for all surgeons, wound
closed in layers and suturing the external oblique
aponeurosis, no wound spray or antiseptic used, wound
dressed with non-adherent absorbable dressing.
Study duration: 1 month
Mortality:
None
Wound infection defined as: discharge of serous or
purulent material, gross inflammation without discharging
pus or any evidence of intra-abdominal sepsis
Assessed at: up to 1 month
Assessor: independent assessor
Outcomes: Wound infection
SSI rates: 65/ 307 Catgut
37/308 Dexon
significant difference(P=0.002)
Mortality: not stated.
A: Staples (n=86 but 2 had 2nd procedure and 1 died
within 2 weeks)
B: Sutures (n=84 but 5 had 2nd procedure and 2 died
within 2 weeks)
Baseline comparability: yes
Loss to follow-up: 10 (6%)
Surgical site infection: full guideline DRAFT (April 2006)
Superficial infections (erythema + serous leak): 2 (2%) in
A vs. 6 (8%) in B, NS
Deep infections: 1 (1%) vs. 1 (1%), NS
Cost: Staples 4.34 € vs. 1.55 € for sutures (no SDs given)
Page 474 of 599
DRAFT FOR CONSULTATION
Cost-effectiveness evidence table
Study
Angelini et
al., 1984
Methods
Cost-consequences analysis
Clinical effectiveness
Randomised controlled trial
(n=113). Outcomes studied:
duration of wound closure;
discharge, oedema,
inflammation and infection
measured on a 1-4 scale on
day 5; grade of wound
healing on day 10; and
cosmetic results on day 45.
Costing
Costs included: unit cost per
10cm of wound length. Price
year not reported.
Population
Patients
undergoing
leg wound
skin closure
after
removal of
the long
saphenous
vein as part
of coronary
artery
bypass
grafting
(CABG)
Interventions
1) Continuous
vertical mattress
suture of 2/0 nylon
(monofilament
polyamide, Ethicon)
(n=27)
2) Continuous
subcuticular
absorbable suture
of 2/0 polyglycolic
acid (Dexon)
(n=29)
Results
Effectiveness
Wound discharge: Dexon 1.2; metal staples 1.6 (p<0.05); nylon
vertical mattress suture 1.8 (p<0.01); Op-site 2.2 (p<0.001).
Wound inflammation: Dexon & Op-site 1.5; nylon suture 2.1
(p<0.001); metal staples 1.9 (p<0.05).
There were no significant differences in terms of wound infections
and oedema.
Dexon was more effective in closing the wound than metal staples or
nylon suture (p<0.05).
Cosmetic results were significantly better in wounds closed by Dexon
than metal staples (p< 0.05) or nylon suture (p<0.05).
Duration of wound closure per 10cm of wound length: Nylon:
144seconds; Dexon 264s; Staples 72s; and Op-site 36s.
3) Disposable
metal skin staples
(Premium) (n=27)
Costing
The mean cost per 10cm of wound length was:
Nylon: £0.15; Dexon: £0.72;Staples: £3.60; and Op-site: £0.63
4)“Op-site”
sutureless skin
closure (Smith &
Nephew) (n=30)
Synthesis of costs and benefits
Not combined.
Surgical site infection: full guideline DRAFT (April 2006)
Conclusions
The authors
concluded that
the continuous
subcuticular
Dexon suture
gave the best
results. The
authors
reported that it
was superior
to the other
methods by all
the criteria
except cost
and speed of
insertion.
Comments
The authors reported the
method of randomisation
and patient groups were
shown to be comparable.
However, on the cost side
the authors only included
the unit costs of the
closing material, and did
not include the labour
costs associated with
wound closure. The
authors also failed to
perform an incremental
analysis to see if Dexon
was a cost-effective
closing material when
compared to its two
cheapest alternatives
(nylon sutures or Op-site).
Page 475 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Brasel et
al. 1997
Cost-utility analysis.
Clinical effectiveness
Literature review including
10 primary studies combined
by weighting of data.
Literature review performed
in MEDLINE. Outcomes:
Quality Adjusted Life Years
(QALYs)
Hypothetical
cohort of
patients with
contaminate
d wounds
due to
perforated or
gangrenous
appendicitis.
1) Primary closure
(PC) of the wound.
Effectiveness
The ultimate utility was: 0.99 for PC, 0.98 for DPC and 0.94 for SC.
2) Delayed primary
closure (DPC) of
the wound (on
postoperative day
4).
Costing
The costs per patient were: $2,680 for PC, $2,877 for DPC and
$3,813 for SC.
The authors
concluded that
primary closure
was shown to be
the favoured
method of
management for
contaminated
right lower
quadrant
incisions with a
primary infection
rate of less than
0.27.
The authors performed a
systematic review of the
literature, and data
appeared no to have been
used selectively. The
authors performed
sensitivity analyses to test
the uncertainty in the
model and the parameters
that were most likely to
affect the results. The
model did not include
multiple medical problems
such as the use of
corticosteroids, diabetes,
obesity etc… However,
the results of the model
would appear to be
internally valid.
Groups were shown to be
comparable in terms of
age, gender, weight and
type of operation.
However, the authors
acknowledged that the
study was somewhat
flawed because two
independent variables, i.e.
type of suture and method
of closure were compared
in only two groups of
patients. Hence, it is not
clear which of these two
variables were
responsible for the
differences in outcomes
observed.
3) Secondary
closure (SC) of the
wound.
Costing:
Costs included:
hospitalisation, medication,
supplies and home visits.
The price year was 1993.
Brolin et
al., 1996
A decision tree model was
then used to compare the
three closure methods.
Cost-consequences analysis
Clinical effectiveness
Quasi experimental study
(n=113). Outcomes studied:
wound infections; duration of
wound closure; acute
dehiscence; late incisional
hernias.
Costing
Only the costs of the
materials used were
included in the analysis. The
price year was not reported.
Synthesis of costs and benefits
PC was found to be both less costly and more effective than DPC
or SC.
The cost saving per QALY gained with PC over DPC was $22,635
(population size of 115 patients). The cost saving per QALY gained
with DPC over SC was $22,340 (population size of 24 patients).
Results of sensitivity analysis showed that PC and DPC were
equivalent at a PC infection rate of 27%. The results also showed
that at an infection rate of 32%, PC was superior to DPC and SC
even with successful outpatient management of wounds.
Patients
undergoing
gastric
restrictive
operations
for morbid
obesity.
1) Midline fascial
closure using #1
PDS (Ethicon)
placed in a
continuous fashion
(n=120).
2) Closure of the
linea alba using #1
Ethibond (Ethicon)
placed using an
interrupted figureeight technique
(n=109).
Effectiveness
Acute dehiscence of the midline fascia: Ethibond 2 patients, PDS 0
patients.
There were no wound infections in either group.
Late incisional hernias: 18% Ethibond group, 10% PDS group
(p<0.04).
Duration of wound closure: 13.3min Ethibond, 9.1min PDS
(p<0.0001).
Costing
The cost per suture pack of #1 PDS was $4.63 vs. $1.76 per pack
for #1 Ethibond.
The mean cost of suturing per patient was $4.18 for PDS compared
to $11.09 for Ethibond.
Synthesis of costs and benefits
Not applicable.
Surgical site infection: full guideline DRAFT (April 2006)
The authors
concluded that
#1 PDS placed
in a continuous
fashion provides
a more secure
and costeffective closure
of the midline
fascia in
morbidly obese
patients than #1
Ethibond placed
using an
interrupted
figure-eight
technique.
Page 476 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Chughtai
et al. 2000
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=162). Outcomes studied:
leakage, necrosis,
inflammation, mediastinitis,
and cosmetic outcome
scored on the basis of a 4grade scale.
Patients
undergoing
coronary
artery
bypass
grafting
(CABG).
1) Subcuticular
suture technique
(suture closure –
n=81).
Effectiveness
During hospitalisation period no significant differences were found
between the two groups, although a stronger trend towards
inflammation was noted in the clips group.
In the follow-up period, there was a significantly greater rate of
infection of the sternal wound when closed with clips than with
suture closure (6 vs. 1, respectively; p=0.05).
The two groups were similar with respect to cosmetic outcome.
The authors
concluded that
suture closure
seems to be a
better and
cheaper method
of wound
closure than
skin clips for
patients
undergoing
CABG.
The groups were shown
not to be comparable in
terms of gender and
diabetes, which could
have biased the results.
The authors did not
include the costs of
hospitalisation or
complications, which
could have biased their
results against suture
closure, as this technique
incurred less
complications and
therefore probably
incurred less hospital
costs. The authors did not
perform any sensitivity or
statistical analysis of
costs.
The targeted sample of 80
patients in each group
was not reached.
Therefore the study might
have been underpowered
to detect significant
differences between the
two groups (e.g. length of
stay). It is unclear how the
authors described
significant cost
differences, as they did
not report any p-values
and differences between
the two groups appeared
to be large, especially for
patients requiring ICU
2) Skin stapling
technique (clip
closure – n=81).
Costing
The average cost of wound closure per patient was $Can4.50 and
Can$15 when using the suture and clip closure methods,
respectively.
Costing:
The only costs included
were those of closure. Price
year not reported.
Cohn et
al. 2001
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=51). Outcomes studied:
rates of wound infection,
length of stay, rates of
wound healing per primum,
and wounds healing by
secondary intention.
Costing:
Only hospital charges were
included in the study. The
price year was not reported.
Synthesis of costs and benefits
Not applicable.
Patients
aged 18
years or
older
admitted to
trauma /
emergency
surgery or
colorectal
services,
which were
found to
have dirty
abdominal
wounds at
time of
surgery.
1) Primary closure
(PC). Wounds
closed with skin
staples and
subcutaneous
tissues not
approximated
(n=23).
Effectiveness
In the E/DPC group 14 patients underwent DPC with 3 wound
infections.
There was a significant association between wound infection and
type of skin closure (E/DPC 3/26 vs. PC 11/23, p=0.013).
For patients not requiring intensive care unit (ICU) care (n=31),
hospital length of stay was not significantly different between the
two groups (E/DPC 7.1+/-3.5 days vs. PC 5.3+/-1.4 days).
2) Evaluation of
delayed primary
closure (E/DPC).
Wounds packed
with gauze and not
manipulated until
post-op day 3. If no
wound drainage,
Costing
For patients not requiring ICU care, hospital charges were similar,
E/DPC $22,258 (range: $10,001-$47,927) vs. PC $26,352 (range:
$5,127-$45,822).
Surgical site infection: full guideline DRAFT (April 2006)
For patients requiring ICU care (n=18), hospital charges were also
not significantly different according to the authors, E/DPC $227,237
(range: $11,281-$1,477,043) vs. PC $78,101 (range: $31,497-
The authors
concluded that a
strategy of DPC
for appropriate
dirty abdominal
wounds four
days after
surgery
produced a
decreased
wound infection
rate compared
with PC without
increasing
length of stay or
cost.
Page 477 of 599
DRAFT FOR CONSULTATION
Colombo
et al. 1997
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=614). Outcomes studied:
hospitalisation period,
postoperative incisional
hernias and complication
rates.
Costing
Only the costs of the
materials used were
included in the analysis. The
price year was not reported.
Women
requiring
surgical
treatment of
gynaecologi
c cancer
utilising a
vertical
midline
incision.
the wound was
approximated the
next day.
Otherwise it was
left open and
dressings changed
(n=26).
1) Continuous nonlocking closure with
looped
polyglyconate
suture (Maxon –
n=308).
2) Interrupted
suturing according
to the SmeadJones technique
with #1 plyglycolic
acid (Dexon – n=
306)
$250,078).
care. It is unclear, which
cost categories were
included under hospital
charges.
Synthesis of costs and benefits
Not applicable.
Effectiveness
Hospitalisation period:
Continuous closure group 7.0+/-3.9 days
Interrupted closure group 6.6+/-3.7 days (0.21).
Incisional hernias:
Continuous closure group 10.4%
Interrupted closure group 14.7% (p=0.14)
Abdominal wound infections:
Continuous closure group 1%
Interrupted closure group 1.6% (p=0.5)
Costing
If the 306 patients enrolled in the interrupted suturing arm had been
closed with continuous technique, $1,845 would have been
generated in savings.
The authors
concluded that
interrupted
closure was not
superior to the
continuous
closure, but the
continuous
closure was
preferable
because it was
more costeffective.
The authors
acknowledged that the
cost analysis lacked any
rigorous and well defined
methodology. The cost
analysis was very limited
and only included the
costs of the suturing
materials.
Synthesis of costs and benefits
Not applicable.
Surgical site infection: full guideline DRAFT (April 2006)
Page 478 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Eldrup et
al. 1981
Cost-consequences analysis
Clinical effectiveness
Randomised controlled trial
(n=137). Outcomes studied:
duration of wound closure,
pain and wound infection.
Patients
undergoing
elective
abdominal &
breast
surgery and
having a
skin incision
between 15
and 35cm
long.
1) Proximate
Stapler PSW35
(n=69).
Effectiveness
Number of patients with wound infections:
Stapler: 3; Suture: 7 (p>0.10)
2) Dermalon 3-0
sutures. Method of
closure was
according to
discretion of
individual surgeon,
but as a rule
continuous suturing
was performed
(n=68).
Number of patients experiencing wound pain:
Stapler: 8; Suture: 0
The authors
concluded that there
were no significant
differences in the rate
of wound infection
between the two
groups, and that the
more painful wounds
after stapling did not
require special
treatment. The
authors also
concluded that the
difference in price
using staples for skin
closure would cancel
out the gain in time.
The authors
concluded that
histoacryl glue was
the ideal tissue
adhesive for surface
cutaneous wound
closure in regards to
safety, reliability,
tensile strength and
cost-effectiveness.
It is unclear if patient
groups were comparable
at analysis. The method of
randomisation was not
reported. The authors
performed a very limited
cost analysis, only
including the costs of
suturing consumables,
with the authors not taking
into account the time
costs associated with
wound closure, which
would bias the results
against stapling.
Costing:
Only the unit costs of closing
devices were included. Price
year not reported.
Median duration of wound closure:
Stapler: 80 seconds
Suture: 242 seconds (p<0.001)
Costing
The cost of ratio between Proximate stapler and Dermalon
suture was 47:1 (i.e. 140 to 3 Danish Kroner).
Synthesis of costs and benefits: Not applicable.
Ellis &
Shaikh
1990
Cost-consequences
analysis.
Clinical effectiveness
Retrospective cohort study
(n=210 procedures).
Outcomes studied: good
wound outcome result, i.e.
adequate tissue bonding in
the postoperative period and
cosmetically the incision
healed normally in regard to
colour, thickness & width,
and complications (wound
infections, tissue toxicity)
Patients
undergoing
cutaneous
incisions in
facial plastic
and
reconstructiv
e surgery.
1) Fibrin glue
(Tisseel – n=23
patients, 32
procedures).
Effectiveness
Good results were obtained in 81% of patients in the fibrin
glue group, and 100% achieved good results in the
histoacryl blue tissue adhesive group.
2) N-butyl-2Cyanoarcylate
(Histoacryl Blue –
n=178 proceudres).
No instances of wound infection, tissue toxicity, poor
cosmetic appearance of the incision, no loss of eyelashes or
formation of milia were encountered.
Costing:
Only unit costs of suturing
consumables were included
in the study. The price year
was not reported.
Costing
Tisseel was found to cost $50 for ½ cc, amount which would
then be used in four upper and lower blepharoplasy incision
closures in one patient, and 1 cc was used in facelift
incisions.
Histoacryl was found to cost approximately $23 per tube and
each tube had enough glue for 16 upper and lower
belpharoplasty incision closures in four patients, and eight
facelift incision closures in four patients.
No statistical analysis was
performed to test if
differences in outcomes
between the two groups
were significant. The
interventions were
performed in different time
periods, so external
factors to the study could
have biased the results.
The health outcome used
would appear to be
subjective. The costing
only included the unit
costs of the wound
closure materials and
does not take into account
relevant costs such as
time costs.
Synthesis of costs and benefits: Not applicable.
Surgical site infection: full guideline DRAFT (April 2006)
Page 479 of 599
DRAFT FOR CONSULTATION
Study
Gennari et
al. 2004
Methods
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=133). Outcomes studied:
duration of wound closure,
cosmetic outcome,
complication rates, patient
satisfaction and application
time.
Population
Patients with
benign
mammary
lesions and
operable
breast
cancer.
Interventions
1) Skin closure with
tissue adhesive (2octylcyanoacrylate
– n= 69).
Results
Effectiveness
Mean duration of wound closure: tissue adhesive 19.9 sec,
suturing 2min 25sec (p<0.001).
2) Standard wound
closure; running
subcuticular 4-0 or
5-0 monofilament
(n=64).
Early follow-up:
At 5-10 days after operation there were no signs of infection,
and the wounds healed without sequelae in both groups.
There were no differences in cosmetic outcomes as rated by
patients or surgeon.
Patients’ satisfaction was higher for tissue adhesives than
for suturing (9.5 vs. 7.45, respectively; p<0.001)
Costing:
Costs included: application
of the skin closure, and
physician and nurse
services. Price year not
reported.
Israelsson
& Wilmo
2000
Cost-consequences
analysis.
Clinical effectiveness
Cohort study with historical
controls (n=816). Outcomes
studied: need of hernia
repair.
Costing
Costs included: anaesthesia
and operation, days in
surgical ward, sick-leave,
and medical examinations.
The price year was 1996.
Six- and 12-month follow-up:
There were similar outcomes between groups on the wound
cosmetic evaluation by both plastic surgeons and patients.
Conclusions
The authors
concluded that tissue
adhesive was faster
than standard wound
closure and offered
several practical
advantages over
suture repair. The
authors also
concluded that tissue
adhesive could
significantly reduce
health care costs.
Comments
The analysis of the clinical
study would appear to
have been conducted on
treatment completers only.
Groups were shown to be
comparable. Doctors were
blinded when assessing.
The method of
randomisation was not
reported. All differences in
outcomes and costs were
tested for statistical
significance.
The authors
concluded that an
alteration to the
suture technique
reduced the rate of
incisional hernia and
the number of hernia
repairs required, and
generated savings.
The authors included all
major cost categories
relevant to the public
payer perspective adopted
in the study. The
outcomes of the study did
not include surgical site
infections. The authors
also performed a limited
sensitivity analysis of their
results. However, the
study was performed over
2 time periods with the
potential that external
factors could have
affected the results.
Costing
The total mean cost per patient was €20.3+/-0.8 for the
tissue adhesive group and €29.3+/-1.4 in the suturing group
(p<0.001).
Patients
operated on
through a
midline
laparotomy
incision.
1) Continuous
suture with suture
length : suture
wound length
(SL:WL) ratio less
than 4 (n=453)
2) Continuous
suture with SL:WL
ratio greater or
equal to 4 (n=408)
Surgical site infection: full guideline DRAFT (April 2006)
Synthesis of costs and benefits: Not applicable.
Effectiveness
Patients requiring a hernia repair:
SL:WL ratio < 4: 14 (3.1%) patients
SL: WL ratio > 4: 6 (1.5%) patients
Costing
The intervention (SL:WL ratio > 4) generated savings of SEK
116 per patient, which extrapolated to the whole of Sweden
yielded annual savings of SEK 2,107,140.
Synthesis of costs and benefits: Not applicable.
Results of the sensitivity analysis showed that an
intervention reducing the risk of hernia repair by 0.016 (as in
present study) was cost-effective if it did not prolong
operations by more than 6min.
Page 480 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Maartense
et al. 2002
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=140). Outcomes studied:
duration of wound closure,
cosmetic results as scored
by patients and doctors, and
wound infections.
Patients
scheduled
for an
elective
laparoscopic
procedure
aged 18
years or
above.
1) OCA –
octylcyanoacrylate
(Dermabond) tissue
adhesive (n=48)
Effectiveness
Median time to close wound:
OCA 33s; poliglecaprone 65s; and papertape 26s (p<0.001).
Wound infections:
OCA 5 patients; poliglecaprone 3 patients; and papertape 2
patients (p=non-significant).
Cosmetic results, as scored by patients, were not
significantly different. However, there were significant
differences in cosmetic results, as scored by surgeons, with
wounds in the OCA group having the best cosmetic
appearance (9.3 in the VAS scale) and those in the
papertape group the worst (6.9; p<0.05).
The authors
concluded that
closure with adhesive
papertape was the
fastest and most costeffective method.
The authors omitted some
relevant costs such as
those relating to treatment
of complications.
However, the authors did
include all the costs of the
interventions themselves
(i.e. unit costs of
consumables and time to
closure). It is unclear
which outcome measure
was the primary outcome
of the study.
Costing
Costs included: costs of
materials used, including
those used as a result of
failures and materials used
for wound dressing; and
costs for use of an operating
room and medical
personnel. Price year not
reported.
2) Adhesive
papertape slips
(Steristrips – n=42)
3) Intracutaneous
closure with
poliglecaprone
(moncryl 4/0)
interrupted sutures
(n=50)
Surgical site infection: full guideline DRAFT (April 2006)
Costing
The median (range) cost per patient was:
OCA: €34.01 (15.33-61.99);
Poliglecaprone: €17.82 (3.32-63.46); and
Adhesive papertape: €8.68 (2.64 -43.60; p<0.001).
Synthesis of costs and benefits
Not applicable.
Page 481 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Matin et
al. 2003
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=92). Outcomes studied:
duration of wound closure,
wound morbidity, and
patient satisfaction.
Adult
patients
scheduled
for elective
laparoscopic
surgery by
three
surgical
specialties
(general
surgery,
gynaecology
and
urology).
1) Closure of
laparoscopic portsite incisions using
octylcyanoacrylate
(OCA –
Dermabond) tissue
adhesives (n=50)
Costing
Costs included: costs of
sutures and time costs
associated with the
operating room. Price year
not reported
Sebesta &
Bishoff
2003
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=59). Outcomes studied:
duration of skin closure,
evidence of infection,
dehiscene, seroma, and
general cosmetic
appearance of the wound.
Costing
Costs included: sutures and
costs. Price year not
reported
Patients
undergoing
laparoscopic
surgery and
needing
trocar sites
to be closed.
Wounds less
than or
equal to 1cm
were
evaluated.
2) Closure of
laparoscopic portsite incisions using
traditional
subcuticular
suturing (n=42)
Results
Conclusions
Comments
Wound infection defined as: not stated
Assessed: 2-3 weeks post op.
Assessor: not stated
The authors
concluded that
closure with
OCA required
significantly less
operative time
and had similar
adverse wound
outcomes and
patient
acceptance
rates than
suturing.
The authors did not reach
the targeted sample size,
determined at 150
patients, to detect a
2.1min difference in
closing time. Despite this
the difference in time to
wound closure was such
that the difference was still
significant. The authors
did not perform
appropriate statistical
analyses to test if
differences in cost
between the two groups
were statistically
significant.
The authors
concluded that
for patients with
laparoscopic
trocar site
wounds of less
than 1cm in
length, wounds
healed faster
when skin was
closed with OCA
than when using
subcuticular
sutures, and the
costs were
lower.
Patient groups were not
shown to be comparable
at baseline. The authors
did not discuss the higher
complication rate in the
OCA group.
Effectiveness
Median time to close wound:
OCA 2.5min vs. 6 min suturing (p<0.001)
Patient acceptance and assessment of scars was not significantly
different.
At a mean follow-up of 17 days, wound infections occurred in 5
and 3 patients in the OCA and suturing group (p=0.99).
Costing
Although the price of OCA was more expensive, savings
associated with less time in operation room outweighed the initial
costs. The authors reported that savings of approximately $65 to
$85 per patient could be generated depending on the amount of
OCA used.
1) OCA –
octylcyanoacrylate
(Dermabond), long
chain cyanocarylate
tissue adhesive
(n=30)
Synthesis of costs and benefits
Not applicable.
Effectiveness
Mean (range) closure time:
OCA 3min 42 sec (2.41-5) and 14min 5sec (8.27-24.43) in the
sutures group (p<0.001).
Wound complications consisted of subcuticular seroma (5 in OCA
group and 2 in suturing group).
2) Subcuticular
suture using either
4-0 vicryl or 4-0
monocryl (n=29).
Costing
The mean cost per patient (range) was:
OCA: $193.32 (130-365)
Suturing: $497 (295-835; p<0.005)
Surgical site infection: full guideline DRAFT (April 2006)
Synthesis of costs and benefits
Not applicable.
Page 482 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Shamiyeh
et al. 2001
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=79). Outcomes studied:
wound dehiscene and
infection, optical satisfaction
of patient and dermatologist.
Patients
requiring
varicose
vein surgery.
1) 5-0 monofilament
sutures (n=28)
Effectiveness
10 days postoperatively there were no significant differences
between the three groups in wound infections and dehiscences
(p>0.05).
There were no significant differences in terms of optical
satisfaction with wound of patient and dermatologist after one
year (p>0.05).
Mean closure time (S.D.)
OCA 1.14min (0.24), sutures 0.64min (0.23) and tape 0.58 (0.27;
p>0.05))
The authors
concluded that
comparing 5-0
monofilament
sutures, tapes
and tissue
adhesive for
skin closure
after
phlebectomy,
there was no
difference in
cosmesis, but
closure with
tape was by far
the cheapest
method.
Only unit costs of wound
closure consumables
appeared to have been
included in the study. The
study appeared to have
been underpowered to
detect any statistically
significant differences
between the two groups.
Costing:
Only unit costs of wound
closure consumables were
included in the study. The
price year was not reported.
2) OCA –
octylcyanoacrylate
tissue adhesive
(n=26)
3) Tape placed
crosswise (n=25)
Costing
The median cost of closure of one incision was $3.24 with OCA,
$0.08 with tape, and $0.23 with sutures.
Synthesis of costs and benefits
Not applicable.
Surgical site infection: full guideline DRAFT (April 2006)
Page 483 of 599
DRAFT FOR CONSULTATION
D18: WOUND DRESSINGS FOR SURGICAL SITES
Clinical Effectiveness
Study
Ajao 1977
RCT
Country:
Nigeria
Funding:
NS
Participants
100 participants
2 groups (50 patients per group)
Inclusion / exclusion criteria: NS
Mean age NS
Interventions
Type of dressings:
One type of (traditionally used) dressing was
applied after the surgery – cotton gauze and an
elastoplast (air-tight and relatively water-tight)
Type of surgery, degree of
contamination and incision site
varied
Group 1: 50 pts
Clean: 37
Contaminated: 13
Co-morbidities:
Malnutrition: 6; Obesity: 6
Description of procedure:
Group 1: Dressing applied post-operatively and
left unopened for 7-10 days; only when there was
a suspicion of infection, wounds were redressed
with aseptic technique
Group 2: wound left exposed and without
dressing from 24 to 36 hours after the incisions
were sutured
Group 2: 50 pts
Clean: 29
Contaminated: 21
Co-morbidities:
Malnutrition: 4; Obesity: 3
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Definition of infection: NS
Outcomes and tools: number of wound infections
Follow up: NS (unclear when the f-u wound assessment happened)
Assessment by: NS
Antibiotics given
Results:
Infection: number of infections (%) according to a type of surgery and
co-morbidities:
Group 1: 50 pts total per group (dressing 7-10 days)
Clean: 5 of 37 pts (13.5%); Contaminated: 9 of 13 pts (62.2%)
Co-morbidities:
Malnutrition: 2 of 6 pts (33.3%); Obesity: 4 of 6 pts (66.7%)
Group 2: 50 pts (no dressing after 24-36 h post-operatively)
Clean: 2 of 29 pts (7%); Contaminated: 7 of 21 pts (33.3%)
Co-morbidities:
Malnutrition: 3 of 4 pts (75%); Obesity: 2 of 3 pts (66.7%)
Scarring, pain, acceptability, ease of removal and costs: not reported
Page 484 of 599
DRAFT FOR CONSULTATION
Study
Chrintz
1989
RCT
Country:
Denmark
Funding:
NS
Cosker
2005
Participants
1325 participants
2 groups (g.1: 633, g.2: 569 pts
analysed)
Inclusion / exclusion criteria: age >
3years
50% male
Type of surgery: herniotomy (423
cases); appendisectomy (157),
Caesarean section (88) and others
Degree of contamination: clean (2/3)
and clean contaminated (1/3), same
ratio in both groups
Incision length: NS
Co-morbidities: NS
Implants used: NS
Inclusion: 300 patients undergoing
hip or knee surgery (emergency or
elective)
Exclusion: No consent, dressing
allergies, closed fracture with
existing blisters
Interventions
Type of dressings:
One type of dressing applied – “sterile dressing”
(no more information provided
Description of procedure
Group 1: sterile dressings applied at the end of
the operation and left until the sutures were
removed
Group 2: sterile dressings applied at the end of
the operation and left for 24 h, then removed and
the area left uncovered
Patients in both groups allowed to shower from
the first post-op day
A: Primapore (n=100)
B: Tegaderm with pad (n=100)
C: Op-site Post-op
Baseline comparability: No – group
C older (no figures given)
Loss to follow-up: Not stated
Outcomes
Definition of infection: “a wound defined as being infected by secretion
of pus from the cicatrix, suture canals, or subcutaneous abscess
Outcomes and tools: number of wound infections
Follow up: “on suture removal”
Assessment by: NS
Antibiotics given: NS
Results:
Infection:
Total number of infections 58 (4.8%): 42 in clean wounds (4.8%), 16
in clean contaminated wounds (4.9%)
Infection:
Group 1: 31 (4.9%);
Group 2: 27 (4.7%)
Surgical intervention needed:
Group 1: 12 (1.9%);
Group 2: 10 (1.8%)
Scarring, pain, acceptability, ease of removal: not evaluated
Wound infection:
A: 5
B: 5
C: 4, NS
Blistering
A: around 23% (read off graph)
B: around 16%
C: around 6% (p<0.001)
Number of dressing changes 2-3 in each group, NS
Serous discharge:
A: 26%
B: 21%
C: 7%
Surgical site infection: full guideline DRAFT (April 2006)
Page 485 of 599
DRAFT FOR CONSULTATION
Study
Gardezi
1983
RCT
Country:
Pakistan
Funding:
NS
Participants
100 participants
2 groups (50 matched pairs, each of
the pair randomly assigned to the
different group)
Inclusion criteria: general surgery
patients
Exclusion: children <12y,
unconscious and unresponsive pts
Mean age range 12-70, most pts 2140
66% % males
Type of surgery: general (most
inguinal herniorrhaphies (14 pairs),
appendisectomies (12 pairs)
Degree of contamination: clean and
clean contaminated
Incision length: NS
Co-morbidities: NS
Implants used: NS
Interventions
Type of dressings:
Group 1:polyurethane membrane (transparent
film)
Group 2: conventional gauze d.
Description of procedure:
Dressings applied after the operation.
Group 1: polyurethane membrane left until
removal of the stitches. Fresh film applied on
discharge which was left until the first visit to the
out-door after a week.
Group 2: conventional gauze d. changed after
48h.
If infection occurred dressings were changed
more frequently.
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Definition of infection:
Outcomes and tools: wound infections, oedema, redness,
haematoma, discharge, skin maceration; patients reaction to the
dressing (simple scale 0, +, ++, +++: comfort of dressing, appearance
of wound)
Follow up: period of f-u and timing of assessments NS
Assessment by: wound observations recorded simultaneously by the
same observer (NS whom)
Antibiotics given: Both members of the group received same
antibiotics for equal duration of time (varied acc to the surgery)
Results
Wound infections
Group 1: 3 pts (2 appendisectomies, 1 inguinal herniorrhaphies)
Group 2: 6 pts (3 appendisectomies, 2 inguinal herniorrhaphies, 1 I/M
nailing femur)
Pain and tenderness:
Group 1: 1 pts
Group 2: 2 pts
Allergic reaction to the adhesive:
Group 1: 2 pts
Group 2: 5 pts
Bullae formation:
Group 1: 1 pts
Group 2: 4 pts
Haematoma:
Group 1: 0 pts
Group 2: 1 pts
Acceptability, ease of removal: not evaluated
Costs: none provided
Page 486 of 599
DRAFT FOR CONSULTATION
Study
Holm 1998
RCT
Country:
Denmark
Funding:
NS
Participants
73 participants
2 groups (36 and 37 patients per
group)
Inclusion / exclusion criteria:
Pts with underlying disorders
excluded (e.g. diabetes, use of syst.
corticosteroids)
Mean age 61.3 y (range 25-90),
groups comparable
Type of surgery: abdominal
Degree of contamination: clean
Incision site ( + length):
Co-morbidities: NS
Implants used: NS
Law 1987
RCT
Country:
UKK
Funding:
NS
170 participants
3 groups (1g: 53, 2g: 59, 3g: 54
patients per group)
Inclusion / exclusion criteria: NS
Type of surgery: elective, inguinal
hernia repair or high saphenous
ligation
Degree of contamination: clean
Incision length: NS
Co-morbidities: NS
Implants used: NS
Interventions
Type of dressings:
1. occlusive hydrocolloid dressing (Comfeel Plus)
removed after 10 days when sutures removed
(n=36)
2. conventional dry gauze dressing (Mepore)
removed after 2 days – control, (n=37)
Description of procedure
At the end of surgery photographs were taken
and dressings applied. Dressings were examined
daily until patient’s discharge, and changed only if
there was an exudate leakage or dressing
slipped. Dressing was discontinued if a clinical
wound infection developed. The gauze dressing
removed 2 days postoperatively (standard local
practice) and occlusive dressing removed 10 days
postoperatively together with suture removal.
Type of dressings:
1. exposed wound (no dressing)
2. dry gauze
3. polyurethane film d. (Opsite)
At wound closure, swabs were taken, wound was
sutured and dressing applied or the theatre gown
pulled down over the exposed wound. Dressing
left intact for 5 days, then the wounds were
assessed. If the wound discharged, the exposed
wound was covered, dressings were changed
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Definition of infection: clinical wound infection diagnosed by pus,
pyrexia, and local tenderness
Outcomes and tools: wound infections, dressing adherence, leakage,
and cosmetic appearance 3 months later
Follow up: daily evaluation till discharge and f-u at 3 months
Assessment by: patients and “independent observers”
Antibiotics given: NS
Results:
Infection: 6 pts developed infection, 5 in Mepore group and 1 in
Comfeel group (ns, p=0.2), and were excluded from the study;
infection was “probably related to dressing”
Scarring: at 3m – ns differences between the groups in scar colour,
elevation, and width
Pain: not assessed
Acceptability: patients comfort and well-being better in occlusive
group (easier bathing and postoperative mobilisation)
Ease of removal: ns differences between patients discomfort at
dressing removal
Adverse events: 9 patients (5 Comfeel g. and 4 Mepore g.) had their
dressing changes due to leakage or loosening (ns differences)
Definition of infection: discharge of purulent material from the wound,
all fluid discharging from the wound underwent bacteriological culture
Outcomes and tools: number of wound infections, quality of scar,
wound discomfort dressing preference (linear analogue scale)
Follow up: 5 days
Assessment by: NS
Antibiotics given: NS
Results
Infection: 1.exposed: 1; 2.dry gauze: 3; 3.polyurethane: 5; between
group differences ns
Scarring: no ss difference is the quality of the final scar
Pain, acceptability, ease of removal: not reported
“No difference in dressing comfort or dressing preference between the
different groups”
Page 487 of 599
DRAFT FOR CONSULTATION
Study
Michie
1994
RCT
Country:
USA
Funding:
Convatec
(manufact
urer of
DuoDERM
)
Participants
28 participants, 40 incisions
2 types of dressing evaluated
(patients served as their own control
- half of the incision randomised to
the first dressing, other half to the
second dressing)
Pts with underlying disorders
excluded (e.g. diabetes, use of syst.
corticosteroids)
Mean age 60 y ± 20.2 (range 1488), 46.4% male
All in good health
Type of surgery:
Elective plastic and reconstructive
surgery
Degree of contamination: clean
Incision site varied (ear and breast
mostly)
Length of incision (per dressing):
mean 21.4 ± 9 mm (range 4.5-46.0)
Co-morbidities: no
Implants used: breast augmentation
(14.3%)
Interventions
Type of dressings:
1. occlusive (DuoDERM)
2. impregnated gauze (Xeroform)
Description of procedure
At the end of surgery, the wound was cleansed
with a physiological saline, photograph taken and
half of the incision covered with the occlusive
dressing, and the other half with the impregnated
gauze dressing
Computer-generated random number table with
blocks of 4 used to determine a position of
dressings
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Definition of infection: NS
Outcomes and tools: incidence of post-operative would infections;
healing time; characteristics of the scar (3-point scale), patient comfort
(standard 10-point VAS), ease of use and removal (3-point scale)
Follow-up: 2-3 days (dressing removal, application of new dressing);
7-10 days (dressing and suture removal), 4 weeks and 7 months postoperatively
Assessment by: surgeon and patient
Antibiotics given: NS (presumable none)
Results:
Infection: No infection at any time point
Scarring: no difference in cosmetic results at 6-7 days f-u, but at 4
weeks occlusive dressing rated ss better by patients and surgeon, no
ss difference at 7 months
Pain: minimal for both dressings except for pain at dressing removal
(low but significantly greater for occlusive dressing)
Acceptability: patients rated occlusive dressing higher then
nonocclusive
Ease of removal: Pain upon removal ss higher for occlusive dressing
(p=0.03)
Surgeons’ assessment at 6-7 days: occlusive dressing judged ss
better for protection of the wound, retention of wound exudates,
facilitation of mobility and personal hygiene
“perfect agreement in patients’ and surgeons’ assessments”
Adverse events: none reported
Page 488 of 599
DRAFT FOR CONSULTATION
Study
Moshakis
1984
RCT
Country:
UK
Funding:
NS
Participants
120 participants
2 groups (g1: 61, g2: 59 pts)
Inclusion / exclusion criteria: NS
Mean age 40 ± 2 y,
100% female
Type of surgery: excision of breast
lump
Degree of contamination: NS (clean)
Incision length: 3.3 ± 0.5 cm
Co-morbidities: NS
Implants used: NS
Interventions
Type of dressings:
Group 1: Tegaderm – polyurethane membrane
Group 2: dry gauze
Description of procedure:
Group 1: Dressing applied after the surgery,
suction drains were tied by the adhesives of the
dressing. To remove suction drain, d. was split
and drain pulled free. Any serous collection under
the dressing was aspired and the puncture
covered by a small piece of transparent dressing
tape.
The dressing left undisturbed until suture removal
(6-8 days)
Group 2: 4-6 dressings (10 x 10 cm) applied to
the wound and secured in place by 4 cm strips of
adhesive tape (Transpore or Elastoplast).
Dressing changed on first pot-operative day and
patients provided with a supply of dressings.
Outcomes and results
Definition of infection: NS
Outcomes and tools: appearance of the wound (presence of
erythema, induration, tenderness, scab formation and serous
discharge; patients comfort and pain; using a scale 1-10 (10 worst)
and wound assessment – very good, reasonable, poor
Infections not specifically assessed
Follow up and assessment by: first post-op day (discharge) – by a
nurse; on suture removal (6-8 days post-op) – by patients and doctor
(senior house officer)
Antibiotics given
Results
Infection: NS
Scarring: assessed in wound classification
Pain, Acceptability: assessed as part of the score
Ease of removal: not assessed
Overall scores (1-no trouble, 10 very troublesome): mean ± SEM
2. by nursing staff (reflects wound appearance, serous or blood
discharge, drain removal)
Group 1(Tegaderm): 1.2 ± 0.08
Group 2 (dry gauze): 5.42 ± 0.44
p<0.001
3. by patients (reflects discomfort and pain)
Group 1(Tegaderm): 1.6 ± 0.19
Group 2 (dry gauze): 5.1 ± 0.36
p<0.001
4. final appearance of the wound by medical staff:
Group 1(Tegaderm): 78% very good
Group 2 (dry gauze): 45% very good, no comparative statistics
presence of erythema, induration, tenderness, scab formation and
serous discharge:
Group 1(Tegaderm): one of the above present in 12.6% patients
Group 2 (dry gauze): one of the above present in 38.2% patients;
no comparative statistics
Surgical site infection: full guideline DRAFT (April 2006)
Page 489 of 599
DRAFT FOR CONSULTATION
Study
Phan 1993
RCT
Country:
Belgium
Funding:
NS
Participants
207 participants
2 groups (g1: 93, g2: 86 pts
evaluated)
Inclusion criteria: head and neck
cancer stage II,III,IV and recurrent
pts
Exclusion: certain types of head and
neck surgery
Mean age 57 y (range 21-84),
155 males, 24 females
both groups compatible
Type of surgery: extensive head and
neck surgery
Degree of contamination: clean
contaminated
Incision length: NS
Implants used: NS
Interventions
Type of dressings:
Group 1: pure vaseline ointment (Qualifar) without
gauze dressing
Group 2: standard gauze dressing
Description of procedure:
Dressings applied at the end of surgery
Group 1: vaseline removed twice daily using
sterile gauze, followed by cleaning of the wound
with alcoholic chlorhexidine solution and
application of new cover of pure vaseline
Group 2: standard gauze dressing changed twice
daily with a similar wound cleaning procedure as
Group 1
Outcomes
Definition of infection: clinically defined infection localised at the
surgical site and presenting with a purulent discharge with a severe
inflammatory reaction (>5cm of erythema and induration);
mucocutaneous fistula also considered to reflect wound infection
Outcomes and tools: wound infections, bacteremia and
bronchopneumonia, need to administer antibiotics post-op
Follow up: wound evaluated within 20 days after surgery
Assessment by: NS
Antibiotics given: all patients given antibiotic prophylaxis (comparable
in both groups, details given in the paper)
Results
Wound infection:
Group 1: 29 pts (31.2%)
Group 2: 21 pts (24.4 %)
Median duration prior to the onset of wound infection (days):
Group 1: 9 days (range 5-15); Group 2: 8 days (range 4-15)
Other infections:
Group 1: 13 pts; Group 2: 17
Antibiotic treatment:
Group 1: 32 pts; Group 2: 32 pts
All differences between the groups ns
Scarring, pain, acceptability, ease of removal: not evaluated
Costs: none provided
Surgical site infection: full guideline DRAFT (April 2006)
Page 490 of 599
DRAFT FOR CONSULTATION
Study
Scott 1982
RCT
Country:
UK
Funding:
NS
Terrill
2000
RCT
Country:
Australia
Funding:
hospital
Participants
291 participants
2 groups (g 1:144 pts – 55
completed, g2: 147 pts – 62
completed)
Inclusion / exclusion criteria: NS
No info about patients provided
Interventions
Type of dressings:
Group 1: wound isolator
Group 2: standard gamma-irradiated adhesive
dressing (no more information provided on the
dressing)
Type of surgery: nailplate fixation of
femoral neck fracture
Degree of contamination: NS
(clean?)
Incision length: NS
Co-morbidities: NS
Implants used: NS
Description of procedure:
Bacteriological monitoring of the patient carried
out before, during and after operation. The
isolators and standard adhesive dressings were
left undisturbed until the 10th post-operative day,
when the stitches were removed. Many patients
pulled off their isolators in early post-op period
and had to be excluded.
108 participants
3 groups (1g:36,2g:35,3g:37
patients)
Inclusion / exclusion criteria:
Mean age 37 y (range 2-82), 68%
male, adults and children
Type of dressings:
1. Jelonet (control) – paraffin-impregnated gauze
2. Adaptic – cellulose acetate fibre d. coated with
a petrolatum emulsion
3. Mepitel – polyamide net dressing impregnated
with silicone gel
Type of surgery: elective clean
incised wounds (55) and traumatic
wounds (53) in hand surgery
Degree of contamination:
Incision site ( + length): hand
(majority on fingers
Co-morbidities: NS
Implants used: NS
Description of procedure:
Surgeons applied chosen dressing in the
operating theatre, and ease of application noted;
the dressing was left intact until the first f-u
appointment (mean 10 days, range 3-18) were
the dressing was assessed by a nurse
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Definition of infection: Classified as minor or major. Minor (superficial)
defined as any redness or discharge in relation to the wound that
showed pus cells and grew microorganisms on culture but resolved
completely without treatment. Major (deep) diagnosed clinically and
bacteriologically, was deep to the fascia and required treatment
(antibiotics, wound drainage, removal of the nail plate)
Outcomes and tools: wound infections (clinical assessment and
culture)
Follow up: up to 10th post-operative day
Assessment by: NS
Antibiotics given: NS
Results:
Infection: major
minor
Group 1: 1
0
(1.8%)
Group 2: 7
5
(21%)
ss, p<0.01
Scarring, pain, acceptability, ease of removal: not assessed
Costs: none provided
Definition of infection: NS
Outcomes and tools: condition of the wound (clean, inflamed or
infected), appearance of the wound, pain experienced at d. removal
(analogue scale 0-10), ease of removal
Follow up: first f-u appointment (mean 10 days, range 3-18)
Assessment by: initial assessment by surgeon, f-u assessment by
nurse, pain by patient
Antibiotics given: NS
Results
Infection: Adaptic and Mepitel groups showed less evidence of wound
inflammation and infection along suture lines. Not reported separately
for incision wounds.
Jelonet: 9 pts (26%) inflammation; 2 (5%) infection
Adaptic: 2 (6%) inflammation; 0 infection (borderline ss difference
compared with Jelonet, p=0.052)
Mepitel: 2 (6%) inflammation; 1 (3%) infection (ns difference
compared with Jelonet, p=0.25)
Page 491 of 599
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Scarring:
No pain on removal:
Jelonet: 51% pts
Adaptic: 75 % (ss difference compared with Jelonet, p<0.01)
Mepitel: 56% (ns difference compared with Jelonet)
Acceptability: not assessed
Ease of removal: reported as very easy in
Jelonet: 57% pts
Adaptic: 88 % (ss difference compared with Jelonet, p<0.05)
Mepitel: 84% (ns difference compared with Jelonet)
Wikblad
1995
RCT
Country:
Sweden
Funding:
NS
250 participants
3 groups (92,77,81 patients per
group)
Inclusion / exclusion criteria: NS
Mean age 64 y (range 38-85), 74%
male
Type of surgery: elective coronary
bypass or valve replacement
Degree of contamination: NS (clean)
Incision site ( + length): NS
Co-morbidities: NS
Implants used; no
Type of dressings:
1. absorbent dressing (control) – conventional
nonocclusive d., 10 x 30 cm)
2. hydrocolloid d. – occlusive d. (DuoDERM,
Convatec/Bristol-Myer Squibb), 3 x 20 cm
3. hydroactive d. – (Cutinova hydro, Beiersdorf
AG, Hamburg)
Definition of infection: NS
Outcomes and tools: wound culture (taken on day 5), photograph
assessment (redness – 3-ponts scale, wound healing – 3 categories,
skin changes) by two blinded raters, pain at removal (3-point scale)
Follow-up: daily assessment by a trained nurse for 5 days after the
surgery, weekly assessment by a patient for 2 weeks, final evaluation
th
by a public health nurse visit at 4 week
Description of procedure:
Dressings applied after operation, examined daily
and changed only if there was a exudates
leakage; dressings left in place for 5 days and
then removed, picture of the wound taken,
patients discharged and instructed to assess the
wound once a week for 2 weeks,
Antibiotics given: 11 patients (due to wound infections)
Results:
Infection: in 11 patients (8 infections in sternum incisions; 5 of 8 found
in the absorbent g.; 3 NS); at 4 weeks 8 wounds infected, 6 of them in
absorbent g.
Wound healing: hydroactive (27% well healed) – significantly worse
when compared with absorbent (57% well healed) or hydrocolloid
(50%); no sign. difference between the absorbent and hydrocolloid
Redness – same pattern as the wound healing
Ease of removal: absorbent d. significantly easier to remove then the
other two
Pain at removal: hydrocolloid (14% reported no pain) and hydroactive
(61% reported no pain) significantly more painful to remove then
absorbent (76% reported no pain)
Adverse events: skin changes (erythema) in 25 pts: 19 in hydroactive
g.; 4 absorbent; 2 hydrocolloid . Blisters – 2 pts in hydroactive g.
Surgical site infection: full guideline DRAFT (April 2006)
Page 492 of 599
DRAFT FOR CONSULTATION
Study
Wynne
2004
RCT
Country:
Australia
Funding:
NS
Participants
737 participants
3 groups (243,267,227 patients per
group)
Inclusion / exclusion criteria:
inclusion consecutive patients
undergoing cardiac surgery who
required a median sternotomy
incision. Exclusion: patients unable
to provide written consent, or were
immunosuppressed or under care of
surgeon who did not want patient to
participate.
Mean age 66 y, 73-78% male
Type of surgery: cardiac surgery
requiring a median sternotomy
incision.
Degree of contamination: NS (clean)
check this
Co-morbidities:
COPD: group 1: 8%, 2: 6%, 3: 10%
Diabetes type II: 1: 37%, 2: 28%, 3:
27%
Renal impairment: 1: 8%, 2: 7%, 3:
5%
Implants used; no
Interventions
Type of dressings:
1. Dry absorbent dressing (Primapore; Smith &
Nephew; control); n=243
2. Hydrocolloid dressing (Duoderm Thin,
Convatec); n=267
3. Hydroactive dressing (Opsite; Smith &
Nephew) n=227
Description of procedure:
Dressings applied after operation, examined daily
for 5 days; follow up by phone or outpatient
department after 4 weeks.
Group 1: dressing removed on day 2 and
cleansed with saline then left exposed; groups 2
and 3: dressings removed on day 5.
In presence of continued exudate, group 1
patients had their dressings replaced by gauze
and tape, groups 2 and 3 had wounds dressed
according to surgeons request.
Outcomes
Definition of infection: according to guidelines of the Centers for
Disease Control and Prevention, and classified as superficial
(involving skin and subcutaneous tissues) or deep (involving muscle,
bone or mediastinum in conjunction with one of: excision of wound
tissue, a positive wound culture finding or treatment with antibiotics.
Outcomes and tools: number of patients with infections (as defined
above), wound healing (assessed using wound approximation and
skin integrity), patient comfort (four VASs 0-10cm used to measure
dressing awareness, movement limitation, comfort with dressing
changes, and overall satisfaction. Patients asked about complications
(pain, tenderness, redness, swelling, discharge or ooze from the
wound and if received antibiotics from their local doctor.
Follow up: measured daily for first 5 days in the surgical ICU then
weekly reports. Median presentation of infection was 38.5 days, range
34-43 days. First f-u appointment median 37 days (range 33 to 47 d)
after day of surgery (through outpatient department or telephone);
86% available
Assessment by: initial assessment by cardiothoracic unit registrar,
then nurse, patient comfort by patient
Antibiotics given: NS
Results
Infection:
1. Total: 6/243; superficial: 1, Deep: 5
2. Total: 6/267; superficial: 5, Deep: 0
3. Total: 9/227; superficial: 4, Deep: 5
Wound healing (at 1-5 days)
Total: 1: 242/243; 2: 266/267; 3: 226/227
Dehisced 1: 0; 2: 1, 3: 0
Postoperative length of stay:
1: 11 (SD 8.8); 2: 10.6 (12.6); 3. 10.1 (6.8)
Patient comfort days 1 to 5:
Patients with dressing awareness. 1: 49/243; 2. 77/267; 3: 80/227
With movement limitation. 1: 30/243; 2. 61/267; 3. 60/227
Discomfort with removal. 1: 142/243; 2: 202/267; 3: 166/227
Dissatisfied. 1: 46/243; 2:75/267; 3: 80/227
On post-op day 2, patients found the Opsite dressing impacted on
their ability to move without feeling limited (p=0.04).
Surgical site infection: full guideline DRAFT (April 2006)
Page 493 of 599
DRAFT FOR CONSULTATION
When a dressing change was required on post-op day 1, patients in
group 2 were more uncomfortable than in the other two groups
(p=0.038).
Despite this, patients in group 2 were more satisfied with their
dressing on post-op days 1 (p=0.027) and 2 (p=0.022)
Scarring not reported
Ease of removal: not reported
Number of patients requiring replacement dressings:
1: 30/243; 2: 134/267; 3: 65/227
Surgical site infection: full guideline DRAFT (April 2006)
Page 494 of 599
DRAFT FOR CONSULTATION
Cost effectiveness
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Terrill 2000
Cost-consequence
analysis.
Clinical effectiveness
Randomised controlled
trial (n=108). Outcomes
studied: surgical wound
infections and
inflammation,
appearance of the
wound, pain
experienced by patient
at removal and ease of
removal.
Patients
undergoing
either elective
or emergency
hand surgery.
1) Jelonet:
paraffinimpregnated
gauze dressings
(n=36)
Effectiveness
Condition of the wound:
Jelonet: 26% inflammation, 5% infection;
Adaptic: 6% inflammation, 0% infection (p=0.052 compared to Jelonet);
Mepitel: 6% inflammation, 3% infection (p=0.25 compared to Jelonet)
2) Adaptic:
cellulose acetate
fibre dressing
coated with a
petrolatum
emulsion (n=35)
No pain at removal:
Jelonet: 51%;
Adaptic: 75% (p<0.01 compared to Jelonet);
Mepilet: 56% (p>0.05 compared to Jelonet).
The authors
recommended that
Adaptic should be
used routinely as the
non-adherent
dressing for incisions
or traumatic wound
on the hand.
The study appeared to
be underpowered to
detect statistically
significant differences in
terms of wound infection
and inflammation. The
costing exercise only
took into account the
unit cost of the dressing,
and did not include the
frequency of dressing
changes nor the labour
costs associated with
dressing change. These
important omissions
could have biased the
authors’ results.
Costing
Undertaken
prospectively.
Costs included: unit
costs of dressings.
3) Mepited:
polyamide net
dressing
impregnated with
silicone gel (n=37)
Dressing removal reported as very easy:
Jelonet: 57%;
Adaptic: 88% (p<0.05 compared to Jelonet);
Mepitel: 84%(p>0.05 compared to Jelonet).
Costing (costs of dressing per sheet)
Jelonet (10x10cm): AU$0.48;
Adaptic (7.6x7.6cm): AU$0.48;
Mepitel (5x7.5cm): AU$5.87.
Synthesis of costs and benefits
Not applicable.
Surgical site infection: full guideline DRAFT (April 2006)
Page 495 of 599
DRAFT FOR CONSULTATION
Study
Methods
Population
Interventions
Results
Conclusions
Comments
Wikblad &
Anderson
1995
Cost-consequence
analysis.
Clinical effectiveness
Randomised controlled
trial (n=250). Outcomes
studied: wound healing
as rated in a three point
scale; positive cultures;
possibility of inspecting
the incision through
dressing; ease and pain
of drain removal;
number of dressing
changes; and patient
ratings.
Patients
undergoing
elective
coronary
bypass or
replacement
surgery.
1) Absorbent
dressings (n=92)
Effectiveness
Wound healing: hydroactive dressings had significantly poorer wound
healing (27% well and 25% partially healed) compared with absorbent
dressings (57% well and 33% partially healed; p<0.0001), and with the
hydrocolloid dressings (50% well healed and 27% partially healed;
p<0.02).
Nurses found it significantly easier to remove absorbent dressings than
hydrocolloid and hydroactive dressings.
Hydroactive and hydrocolloid dressings were significantly more painful
at removal than the absorbent dressings.
Absorbent dressings required the highest number of changes (1.7 per
patient) than the hydrocolloid (1.2 per patient) and hydroactive
dressings (1.2 per patient) (p<0.001).
Four weeks after surgery a total of 8 wounds were found to be infected,
6 of which belonged to the absorbent dressing group.
The authors
concluded that
absorbent dressings
were safe and
comfortable and gave
satisfactory wound
healing.
It is unclear if groups
were comparable at
analysis in terms of preoperative and operative
characteristics. The
authors did not explicitly
take into account the
time costs associated
with dressing changes.
However the authors
reported it took
approximately 3 minutes
of nursing time to
change an absorbent
dressing at a cost of
$0.50. Net of these
costs, the authors
concluded that
absorbent dressings
were still the cheapest.
The authors
concluded that in the
context of no
additional benefit for
the prevention of
wound healing for any
of the three
dressings, dry
absorbent dressings
were the most
comfortable and costeffective products for
sternotomy wounds
following cardiac
surgery.
Groups were shown to
be comparable in
virtually all preoperative
and operative
characteristics. Data
were only collected for
the first 5 postoperative
days. However, it would
have been useful to
continue data collection
until and beyond patient
discharge. To make the
costing exercise more
complete the authors
should have also
examined the time costs
associated with dressing
changes and other
resource use (e.g.
doctor and nurse visits).
2) Hydroactive
wound dressings
(Cutinova
Hydro;Beiersdorf
– n=81)
3) Hydrocolloid
occlusive wound
dressings
(Duoderm;
ConvaTec – n=77)
Costing
Undertaken
prospectively.
Costs included: costs of
dressings.
Wynne et al.
2004
Cost-consequence
analysis.
Clinical effectiveness
Randomised controlled
trial (n=737). Outcomes
studied: surgical wound
infections, patient
comfort as rated by the
visual analogue scale,
exuding wounds,
frequency of dressing
and rate of wound
healing.
Costing
Undertaken
prospectively.
Costs included: costs of
dressings.
Costing
Mean cost per patient: absorbent dressings $0.73; hydrocolloid
dressings $3.60 and hydroactive dressings $3.34.
Patients
undergoing
cardiac
surgery who
required a
medium
sternotomy
incision in a
major
metropolitan
teaching
hospital.
1) Dry absorbent
dressings
(Primapore; Smith
& Nephew –
n=243)
2) Hydroactive
dressings (Opsite;
Smith & Nephew –
n=227)
3) Hydrocolloid
dressings
(Douderm Thin;
ConvaTec - 267)
Surgical site infection: full guideline DRAFT (April 2006)
Synthesis of costs and benefits
Not applicable.
Effectiveness
No significant differences in terms of incidence of surgical wound
infections and wound healing between groups.
Exuding wounds: dry absorbent 6.9%, hydrocolloid 21.3% and
hydroactive 13.8% (p=0.0001).
Patients receiving dry absorbent dressings had significantly less
movement limitation (p=0.002), discomfort with removal (0=0.05) and
dissatisfaction (p=0.008).
Significantly more patients in the dry absorbent group (90%) required a
single dressing than in the hydrocolloid (50%) and hydroactive (71.7%)
groups (p<0.0001)
Costing
Dry absorbent dressings: median cost AU$0.52 (IQR: $0.52 to $0.52).
Hydrocolloid dressings: median cost AU$3.93 (IQR: $3.93 to $7.86).
Hydroactive dressings: median cost AU$1.59 (IQR: $1.59 to $3.18).
Synthesis of costs and benefits
Not applicable.
Page 496 of 599
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D19: CLEAN VERSUS STERILE TECHNIQUES
Clinical Effectiveness
Author
Partcipants
Intervention
Outcomes
Stotts 1997
N=30
Patients underwent abdominal surgical
procedures.
M=15 F=15
Mean Age= 40.6
+13.0 years
Intervention:
Sterile dressing and sterile dressing change technique.
(N=16)
There was no difference in rate of wound healing
(measured by wound volume) between the clean and
sterile groups (U=89.0p<0.49) at the end of the study.
Comparator:
Clean dressing and clean change technique
(N=14)
One subject in each treatment group acquired infection.
USA
One subject in the sterile treatment group had wound
dehisence and therefore not followed-up.
OM:
Primary-Wound healing
Wound infection
Surgical site infection: full guideline DRAFT (April 2006)
Page 497 of 599
DRAFT FOR CONSULTATION
Cost-effectiveness evidence table (Clean vs. sterile)
Study
Stotts et
al.,
1997
Lawson
et al.,
2003
Methods
Cost minimisation
analysis.
Clinical effectiveness
Randomised controlled
trial (pilot study) with 30
patients.
Outcomes studied: rate
of wound healing.
Costing
Undertaken
prospectively.
Costs included: cost of
clean and sterile
supplies (gloves and
dressings). The price
year was not reported.
Costs and quantities
were not reported
separately.
Cost minimisation
analysis.
Clinical effectiveness
Before and after study
based on 2,033 patients
admitted into two acute
care units.
Outcomes studied:
surgical site infections.
Costing
Undertaken
prospectively. Only
material costs were
included. The price year
was not reported. Costs
and quantities were not
reported separately.
Population
Adult patients
with one or more
open wounds
after elective
operations who
were scheduled
for dressing
change within 24
hours of the
operation.
Hospitalised
adult patients
with one or more
open surgical
wounds healing
by secondary
intention who
were receiving
dressing
changes three
times per day
with normal
saline.
Interventions
Intervention
Sterile dressing and sterile
change technique, defined as
the replacement of the wound
dressing with a new one by
means of aseptic technique
with sterile supplies (n=16).
Comparator
Clean dressing and clean
change technique, defined as
the replacement of the wound
dressing with a new dressing
by means of medical asepsis
with clean supplies (n=14).
The dressing material for both
dressing change techniques
was coarse mesh gauze
moistened with sterile normal
saline solution.
Intervention
Sterile dressing change
technique (involving: new
sterile scissors with each
dressing change, sterile gloves
and sterile bowls for large
wounds) (n=1,070).
Comparator
Clean dressing change
technique (involving: use of
same clean scissors with each
dressing change, clean gloves
and no sterile bowl was
needed) (n=963)
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
There was no difference in wound volume at
the end of the study (p=0.49).
Costing
The average cost for each change of
dressing: sterile technique $21.97 + $12.80;
clean technique $12.38 + $5.80 (p<0.05).
Synthesis of costs and benefits
Not applicable.
Conclusions
The authors
concluded that their
results showed no
difference in rates of
healing when both
dressing changes
were compared. They
also showed that
clean dressings and
technique were less
expensive than sterile
dressings and
technique.
Comments
The study was based
on a small sample size
as this was a pilot
study. Groups were
shown to be
comparable in a number
of baseline
characteristics.
However, the study
might not be sufficiently
powered. The mean
follow-up for both
groups was of only 4.2
+ 1.58 days.
Effectiveness
Surgical site infections: Sterile technique
9/1,070 (0.84%); clean technique 8/963
(0.83%) (p=NS).
Costing
Following a change to clean dressing
technique, the surgical units’ supply budget
decreased by $380, which meant mean
savings of approximately $1,520 per year for
the two acute care nursing units involved.
Two nurses timed the dressing techniques
and determined that approximately 10
minutes were needed to perform clean
wound care; whereas, sterile wound care
took approximately 13 minutes to complete.
Synthesis of costs and benefits
Not applicable.
The authors
concluded that using
clean technique when
changing dressings
for surgical wounds
healing by secondary
intention did not
increase wound
infection rates and
saved time and
money.
The number of SSIs
was based on the
documentations of a
positive wound culture.
However, as cultures
may not have been
performed on all
infected wounds, the
number of infections
may be underreported.
The study was not
based on a randomised
controlled trial or
prospective study with
concurrent controls.
Page 498 of 599
DRAFT FOR CONSULTATION
D20: POSTOPERATIVE WOUND CLEANSING
Clinical Effectiveness
Study
Fraser
(1976)
UK
Johnson
(1985)
UK
Participants
100 patients after surgery with or
without drains
Interventions
Patients randomised to bather group and non
bather group
56 patients undergoing abdominoperineal excision of the rectum for
carcinoma
Wounds cleaned with:
Group A: Normal saline
Group B: 1% Povidone- iodine (50ml)
Neus
(2000)
817 patients having surgery for
varicose veins
Group A: wounds showered on day two-water
only
Group B: wounds showered on day two- water
and shower gel
Group C: wounds kept dry for 8-10 days (not
cleansed
Riederer
(1997)
Germany
121 patients after surgery for
inguinal hernia
Group A: 49 patients showered on day 1
Group B: 52 patients who kept wounds dry for 14
days
Voorhees
(1982)
USA
82 patients after surgery with or
without drains
Group A: Showered on 2nd postoperative day
Group B: Not showered
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Wound healing
4/50 in both groups developed infection. All wounds
healed
Results:
Healing- Primary healing when stitches were removed at
approximately 3 weeks:
Group A: 9/28 ; Group B: 19/28
Healing at 3/12:
Group A: 8/28;
Group B: 7/28
Mean number of days in hospital:
Group A: 28 days; Group B: 19 days
Sinus at 6 months:
Group A: 5/28;
Group B: 0/28
Total infection:
Group A: 21/28; Group B: 10/28
Results:
Infection:
Group A: 0/144
Group B: 0/220
Group C: 0/208
Dehiscence:
Group A: 1/144
Group B: 1/220
Group C: 0/208
Results:
One stitch abscess in each group
No wound infections in either group. Feeling of well being
in shower group
Results:
Infection:
Group A: 2/39; Group B: 4/43
Healed
Group A: 37/39; Group B: 39/43
Page 499 of 599
DRAFT FOR CONSULTATION
D21: DRESSINGS AND TOPICAL AGENTS FOR WOUND HEALING BY SECONDARY INTENTION
Clinical Effectiveness
Study
Cannavo
1998
Setting:
Hospital,
Australia
Participants
N=36
Patients with surgical abdominal
wounds (wound breakdown > 3 cm)
Dawson
1992
N=34
Patients with incised and drained
abscesses (Perianal/pilonidal,
breast, other)
Eldrup 1985
(in Danish;
English
abstract)
Setting:
Hospital and
outpatient
clinic,
Denmark
Goode
(1979)
Setting:
Hospital and
outpatient
clinic, United
Kingdom
N=33
Patients with open therapy after
pilonidal cyst excision (clean or
infected).
N=20
Patients with delayed closure for
heavy contamination – infected
wounds (n=10) or surgical wounds
opened and drained because of
abscess (n=10) (appendectomy or
bowel surgery)
Interventions
Group 1: packing (if cavity) or flat alginate dressing
Group 2: gauze dressing (or packing if cavity)
moistened with sodium hypochlorite (0.05%) then
normal saline (0.09%) when wound granulating, plus a
combine dressing pad
Group 3: a combine dressing pad (cotton wool and
gauze).
All groups had secondary dressing of Tegaderm film
applied with 3cm margin. Once exudate low, all groups
had dressing replaced by hydrocolloid dressing.
Group 1: Calcium alginate cavity pack (Kaltostat,
BritCair)
Group 2: Gauze soaked with saline to pack cavity
In both groups the wound was covered with a gauze
pad.
Interventions
Group 1: Silastic foam dressing n=17
Group 2: Gauze with Chloramine n=16
Interventions:
Group 1: dextranomer polysaccharide beads (Debrisan)
Group 2: Eusol and paraffin soaked ribbon gauze.
[Eusol is sodium hypochlorite solution buffered to
normal pH with boric acid]
Each group had twice daily dressings
Surgical site infection: full guideline DRAFT (April 2006)
Outcomes
Healing rate (wound size reduction per day)
Pain
Patient satisfaction
Cost
Outcomes:
Healing (treatment length; mean and range, p<0.05)
Patient satisfaction
Cost
Nursing time
Outcomes:
Healing (time to wound closure, without recurrent
abscess formation – wound was closed when clean, i.e,
resolution of erythema and oedema, absence of pus or
slough at base, and formation of granulation tissue)
Cost
Hospitalisation
Page 500 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes
Guillotreau
1996
N=70
Interventions:
Group 1: Calcium alginate rope
Group 2: packing with gauze soaked in povidone iodine
Outcomes:
Healing (wound surface reduction (p values) and
number of patients with completely filled wound
cavities)
Pain (p=0.0001 in favour of alginate rope)
Ease of use (p=0.011 in favour of alginate rope)
Interventions:
Group 1: silicone foam elastomer + catalyst (Silastic,
Dow Corning Ltd) n=25
Group 2: ribbon gauze soaked in mercuric chloride
antiseptic solution. n=25
Randomised on postoperative day 14
Pain
Cost
Interventions:
Group 1: polyurethane foam containing hydroactive
particles (Cutin ova cavity dressing, Beiersdorf AG)
n=21
Group 2: moist cotton gauze; solution used to moisten
the gauze was not stated. n=22
Group 1: packing of the abscess cavity with honeysoaked gauze
Outcomes:
Healing (time to use of dry dressing and time to
complete epithelisation; rate of healing reported only for
group 1)
(Conference
abstract
only)
Setting:
Hospital,
France.
Macfie 1980
Setting:
hospital and
outpatient
clinic, UK.
Meyer 1997
Setting:
Hospital,
Germany
Okeniyl
2005
Patients with incision and drainage
of pilonidal abscess (infected)
N=50
Patients with open perineal wounds
after abdominal perineal excision of
the rectum
(proctocolectomy or rectal excision,
mainly for rectal carcinoma); majority
of wounds had breakdown following
primary suture
N=43
Deep cavity wounds in patients
following laparotomy or surgical
incision of an abscess (i.e. part
infected)
N=32
Children with 43 pyomyositis
abscesses. Following fresh surgical
incisions and drainage, all
participants had 21-day course of
gentamycin and wounds left to close
spontaneously.
Group 2: packing of the abscess cavity with Eusolsoaked gauze
Outcomes:
Healing (reduction of wound size over 4 weeks)
Pain
Outcomes:
Time until wounds became clean
Time until granulation tissue present
Time to presence and completion of epithelialisation
Length of hospital stay
Wounds randomised.
Surgical site infection: full guideline DRAFT (April 2006)
Page 501 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes
Schmidt
1991
Setting:
Outpatient
clinic, USA.
N=40
Interventions:
Group 1: aloe vera gel (Carrington Dermal wound gel
formulation) was supplemented on traditional treatment.
Group 2: traditional treatment. The wound was debrided
with either a gauze pad or a scalpel as required and
irrigated with high-volume, high pressure irrigations. A
wet-to-dry dressing was applied. This was repeated
every 8 hours until the commencement of granulation,
after which treatment was repeated every 12 hours.
Outcomes:
Healing (time to healing)
Shackelford
2002
Setting:
Department
of Obstetrics
and
Gynaecology
USA. Post
discharge.
N=24
Group 1: topical recombinant human platelet-derived
growth factor BB gel with low bioburben methylcellulose
carrier n=12
Number of treatment days
Total no. of post operative days to wound closure
Wound closure rates
Vigier 1999
N=56
Setting:
Rehabilitation
center,
France
Patients with below knee amputation
because of arterial disease and
initially had an open stump.
Infection hindering socket contact
was an exclusion criterion.
Patients with surgical wounds
requiring healing by secondary
intention after (caesarean delivery or
laparotomy for gynaecological
surgery). All wounds had opened
spontaneously or had been drained
to treat a seroma, haematoma or
wound abscess before referral. i.e.
infected
Patients with separated abdominal
surgical wounds after caesarean
section or benign abdominal
procedures
Group 2: Placebo with different gel of similar physical
characteristics (SurgiLube) n=12
Group 1: plaster cast (supracondylar-type) socket fitted
on the stumps, interposed with a silicone sleeve directly
on the skin and covered with a tubular piece of jersey
sewn up at the stump end.
Group 2: elastic compression bandage, which were only
removed for dressing changes, which was as thin as
possible
Surgical site infection: full guideline DRAFT (April 2006)
Healing
Hospitalisation
Page 502 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes
Walker 1991
N=75
Healing (time to full healing)
Setting:
Hospital and
outpatient
clinic, United
Kingdom.
Patients with open excision of
Pilonidal sinus (n=38) and
abscesses (n=37). Results reported
separately, but not stratified prerandomisation
Young 1982
N=50
Setting:
Hospital and
outpatient
clinic, United
Kingdom
Patients with surgical wounds that
have either broken down or have
been left open postoperatively
(wound breakdown, appendectomy
for gangrenous or perforated
appendix).; i.e., infected wounds
Group 1: silicone foam cavity dressing (Silastic foam)
pilonidal sinus n=17
abscesses n=17
Group 2: Eusol-soaked gauze at half strength. pilonidal
sinus n=21
abscesses n=20
Both groups had initial treatment with Eusol soaked
ribbon gauze at half strength for 48 hours
Group 1: Debrisan plus standard treatment of change of
dressing twice per day.
Group 2: Silastic foam dressing.
All wounds initially treated with gauze for 48 hours.
Surgical site infection: full guideline DRAFT (April 2006)
Healing (time to heal, mean and SEM)
Pain
Complications
Page 503 of 599
DRAFT FOR CONSULTATION
Cost-effectiveness evidence table
Study
Cannavo
et al.,
1998
Methods
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=36).
Outcomes studied: wound
healing rate, pain intensity,
and patient satisfaction.
Population
Patients
from a
gastrointesti
nal surgical
unit with
surgical
abdominal
wound
breakdown.
Costing
Undertaken prospectively.
Costs included: dressings,
material costs and nursing
time expended in completing
the dressing protocol for
each patient. Price year was
1996..
Intervention
Intervention
Calcium alginate
dressing
(Sorbsan –
n=13).
Comparator
Sodium
hypochlorite
solution (0.05%)
solution
moistened gauze
dressing with a
absorbent
dressing
consisting of
cotton wool &
gauze (n=10)
Combine pad
alone (n=13).
Culyer et
al., 1984
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled
(n=50).
Outcomes studied: time and
rate to full epithelialisation,
time and rate to dry
dressing, assessment of
pain, number of inpatient
days, and number of visits
by district nurse.
Patients with
granulating
perineal
wounds
following
abdominoperineal
excision of
the rectum.
Intervention
Silicone foam
elastomer
dressings
(Silastic DowCorning – n=25).
Comparator
Conventional
gauze dressings
(n=25).
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
Healing rates: No statistically significant differences were
observed.
Maximum pain: The difference was 2.6 with the alginate dressing
group (p=0.011) and 2.3 with the combine group. No significant
difference was observed between the sodium hypochlorite group
and the alginate-dressing group (p=0.689).
Satisfaction: the alginate-dressing & the combine group had similar
satisfaction levels. The sodium group experienced less satisfaction
than the alginate-dressing group (p=0.01) and the combine group
(p=0.015) at the conclusion of the first week. The three study
groups had similar results at the last assessment visit.
Costing
Mean total cost per day:
Alginate-dressing: A$15.25+A$1.26
Sodium: A$19.36+A$1.83 (p=0.069 vs. alginate dressing).
Combine dressing: A$14.14+A$1.71 (p=0.636 vs. alginate
dressing).
Synthesis of cost and benefits
None reported.
Effectiveness
Time to dry dressing: foam 47.5 + 3.1 days; gauze 62.6 + 6.3 days
(p<0.05).
Rate to dry dressing: foam 1.24 + 0.15; gauze 1.07 + 0.11
(p<0.02).
Assessment of pain: 4 (16%) patients in the foam group required
analgesia; 15 (60%) patients in the gauze group required
analgesia.
Number of visits by district nurse: foam 14.1+2.4; gauze
46.9+5.8(p<0.001).
Costing
For several cost categories calculations did not permit for an
estimate of the true mean, and hence three estimates of costs
Conclusions
The authors
concluded that
their results
supported the
view that sodium
hypochlorite
dressing
protocols for
surgical wounds
should be
abandoned, as
patients who
received this
protocol
experienced
more pain and
were less
satisfied than the
patients in the
other two groups.
Comments
The sample size of
the study was
small, and hence
the study was not
sufficiently
powered. The study
groups were not
comparable in all
baseline
characteristics.
Three surgical
nurses performed
the blinded
outcome
measurements of
wound size and
pain, however, no
further information
was provided on
how assessors
were blinded.
The authors
concluded that
the relative
cheapness of
foam elastomer
was a fairly
robust result,
even bearing in
mind the
qualification
concerning the
resources
costed.
The effectiveness
trial included the
following problems:
lack of blinding,
and lack of
information on
method of
randomisation. As
reported in the
authors’
conclusions there
were qualifications
regarding the
costing, as several
Page 504 of 599
DRAFT FOR CONSULTATION
Goode et
al., 1979
Costing
Undertaken retrospectively.
Costs included: material
costs, hospitalisation costs,
nursing time in hospital,
district nurse time spent on
travel and patient care,
morbidity costs due to
complications. The price
year was 1982.
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=20).
Outcomes studied: mean
time to wound closure and
number of days in hospital.
were presented: mean estimate (“medium value” where costs
calculations did not permit an estimate of true mean), low estimate
and high estimate.
Total cost per case:
Foam: £70.50/£162.00/£422.00
Gauze: £146.10/£417.60/£984.40
cost categories
were supplemented
by informed
guesses or
obtained for only a
small sub-sample.
Synthesis of cost and benefits
None reported.
Patients who
had
undergone
abdominal
surgery, with
wounds
healing by
secondary
intention.
Intervention
Dextranomer
polysaccharide
beads (Debrisan
– n=10)
Effectiveness
Mean time to wound closure by secondary intention: dextranomer
8.1 days; gauze 11.6 days (p<0.05).
Hospital stay: dextranomer patients had a shorter hospital stay of a
median of 2.2 days
Comparator
Eusol ribbon
gauze (n=10)
Costing:
The cost of Debrisan for the twice daily dressing of a 10cm wound
was £3.40. The high cost was compensated for by the saving in the
total cost of hospital care resulting from the shorter hospital stay.
Costing:
Undertaken prospectively.
Cost of Debrisan for the
twice daily dressing of a
10cm wound. Price year was
not reported.
Surgical site infection: full guideline DRAFT (April 2006)
Synthesis of cost and benefits
None reported.
The authors’
concluded that
Debrisan was
found to be more
effective than
Eusol, and that
the high cost of
Debrisan was
compensated for
by the saving in
the total cost of
hospital care
resulting from the
shorter hospital
stay.
Page 505 of 599
Groups were not
shown to be
comparable in
terms of wound
size. No follow-up
period was
reported. The
partial economic
analysis was based
on a shorter length
of stay in hospital,
which was not
tested for statistical
significance. The
authors did not
provide the costs of
Eusol.
DRAFT FOR CONSULTATION
Study
Moore &
Foster,
2001
Methods
Cost-consequences
analysis.
Clinical effectiveness
Randomised controlled trial
(n=40).
Outcomes studied: pain,
ease of application &
removal, ability to cope with
exudates, patients’
perceptions.
Costing
Undertaken prospectively.
Costs included: dressings,
analgesia, nursing time to
change the dressings, and
hospitalisation.
Price year not reported.
Costs & quantities not
reported separately.
Population
Patients with
acute
surgical
wounds left
to heal by
secondary
intention.
Intervention
Intervention
Modern
hydrofibre
dressing
(Aquacel,
ConvaTec –
n=20).
Comparator
Ribbon gauze
with proflavine
dressing (n=20).
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
Patients in hydrofibre group experienced less pain (p=0.0006), &
nurses found these dressings easier to remove & replace (p=0.01).
More patients in the hydrofibre group were treated as day cases,
while the ribbon gauze dressing needed to be monitored in hospital
(p=0.02).
Costing
The average cost per patient treated:
Hydrofibre group: £295
Ribbon gauze group: £680 (p=0.01)
Average saving: £385 per patient treated.
Synthesis of cost and benefits
None reported.
Conclusions
The authors
concluded that
their study
showed that
using a modern
hydrofibre
dressing in acute
surgical wounds
left to heal by
secondary
intention
improved
patients’ quality
of life and
reduced pain on
dressing change.
Page 506 of 599
Comments
The authors did not
report if groups
were comparable in
terms of initial
wound size or
wound type. It
remained unclear if
the costs of all
patients were
included in the
analysis. Moore &
Foster, 2000 was
not included in the
HTA report
because it had no
measure of healing,
as did Moore &
Foster 2001.
DRAFT FOR CONSULTATION
Study
Walker
et al.,
1991
Methods
Cost minimisation analysis
Clinical effectiveness
Randomised controlled trial
(n=75).
Outcomes studied: time to
full healing, and time to
hospital discharge.
Costing
Undertaken retrospectively.
Costs included: hospital,
community care and
dressing costs. The price
year was 1989/1990. Costs
and quantities were reported
separately.
Population
Patients who
had received
surgery for
either a
pilonidal
sinus or an
abscess.
Intervention
Intervention
Silicone foam
elastomer
dressing
(Silastic, DowCorning – n=41).
Comparator
Half-strength
Eusol soaked
gauze dressing
(n=34)
Surgical site infection: full guideline DRAFT (April 2006)
Results
Effectiveness
Time to full healing:
Sinuses: foam 30.0 days; gauze 33.0 days (p=NS)
Abscess: foam 39.8 days; gauze 39.6 days (p=NS)
Time to hospital discharge:
Sinuses: foam 12.8 days; gauze 15.2 days (p=NS)
Abscess: foam 11.5 days; gauze 14.6 days (p=NS)
Costing
Patients were discharged on average 3 days earlier if treated with
Silastic foam. Even if not statistically significant, this represented
savings of £400 per patient.
Costs saving to the community nursing service could be between
£100 and £200 per patient if treated with Silastic foam.
Each 20g pack of Silastic foam suitable to make one dressing cost
£5.87. While Eusol and ribbon gauze alone were not expensive,
18 daily treatments equated in cost to three Silastic foam changes.
By using Silastic foam, an average total saving of £500 per patient
could be made.
Synthesis of cost and benefits: Not applicable
Conclusions
The authors
concluded that
pilonidal sinus
disease should be
treated by simple
incision and
Silastic foam
dressing,
reducing hospital
stay time and
nursing
expenditure.
Page 507 of 599
Comments
Groups were not
shown to be
comparable and
the study might
have lacked power
to detect significant
differences
between the two
groups. Cost
results were based
on non-significant
time to hospital
discharge.
DRAFT FOR CONSULTATION
Study
Beiersdorf
13
, 2000
(A
submissio
n to NICE
from
Beiersdorf
UK ltd).
Methods
Cost-minimisation
analysis
Clinical effectiveness
Randomised controlled
trial (n=43).
Costing
Undertaken
retrospectively
Costs derived from a case
study of a patient who had
a postoperative wound
infection following
colorectal surgery and a
survey conducted at an
NHS hospital. Costs
included: costs of
dressings and nursing
time per dressing. Price
year 1998-2000.
Population
Patients with
a deep
secondary
healing
wound after
abdominal
surgery.
Intervention
Intervention
Polyurethane
foam containing
hydroactive
particles
(Cutinova,
Beiersdorf).
Comparator
Moist cotton
gauze.
Results
Effectiveness
Cutinova patients experienced more rapid wound healing and less
pain on changing dressings. Based on the survey in the NHS
hospital, it was found that the dressing time per wound was shorter
in the Cutinova group. The Cutinova group was also associated
with fewer dressing changes.
Costing
The potential savings per week from using Cutinova in the four
week trial were:
Week 1: £20.14 (Cutinova £15.39; gauze £35.53)
Week 2: £15.35 (Cutinova £8.88; gauze £24.23)
Week 3: £9.38 (Cutinova £4.41; gauze £13.78)
Week 4: £5.55 (Cutinova £2.24; gauze £7.79)
Sensitivity analyses were performed by varying the costs and
frequency of Cutinova dressings. If the frequency of Cutinova
dressings doubled the savings would almost disappear but not
quite, suggesting the conclusion was robust. If the Cutinova price
trebled the cost advantage was still retained
Synthesis of cost and benefits
Not applicable
Surgical site infection: full guideline DRAFT (April 2006)
Conclusions
The authors
concluded that
their simple
analysis
suggested that
the use of
Cutinova in
preference to
moist gauze in
the dressing of
difficult to heal
surgical wounds
will save NHS
resources and
reduce costs
both by
decreasing the
spend on
disposables and
by reducing the
nursing time
involved in
dressing
changes. The
authors also
concluded that
given the size
and robust
nature of the
result, it was
unlikely that the
overall
conclusion would
change with
further work.
Page 508 of 599
Comments
No statistical
analysis were
reported both for
the effectiveness or
the cost results,
hence differences
could well be nonsignificant. Even
though sensitivity
analyses were
undertaken for the
costing side, none
was undertaken in
the effectiveness
side. No effort was
made to convert all
costs to a single
price year. The
costing was not
undertaken in the
same sample as
that used in the
effectiveness study.
DRAFT FOR CONSULTATION
D22: TOENAIL AVULSION
Clinical Effectiveness
Study
Denning
2003
Setting:
Podiatry
Department
Primary
Care Trust
United
Kingdom
Participants
N=94 patients undergoing 123 surgical
procedures
All patients attending for nail surgery
who did not fall into the exclusion
criteria
Dovison
2001
Setting:
outpatient
clinics,
Australia
N=42
Patients requiring a partial nail avulsion
of the hallux
Interventions
Intervention:
Group 1: Inadine (antiseptic) dressing and secondary dry
dressing
Group 2: Dry dressing
[Inadine is a knitted viscose fabric impregnated with a
polyethylene glycol (PEG) base containing 10%
povidone-iodine].
Group 1: 0/38
Group 2: 2/63
Outcomes
Outcomes:
•
Healing time
•
Infection
Follow up until healing
Interventions:
Group 1. Povidone-iodine with paraffin gauze dressing
n=13
Group 2. Amorphous hydrogel with paraffin gauze n=16
Group 3: Paraffin gauze n=13
Outcomes:
•
Healing (measured with specific clinical
indicators)
•
Infection (measured with specific clinical
indicators)
Follow up until healed
Results:
(Days) Mean time to healing (SD)
Group 1: 40.1 (18.6) n=38
Group 2: 46.7 (23.2) n=63
Infection
Results:
(Days) Mean time to healing (SD)
Group 1: Povidine-iodine= 34.3 (4.8)
Group 2: Amorphous hydrogel= 33.3 (6.0)
Group 3: Paraffin gauze= 34.2 (7.7) days)
Infection
Group 1: 1/13
Group 2: 4/16
Group 3: 1/13
Surgical site infection: full guideline DRAFT (April 2006)
Page 509 of 599
DRAFT FOR CONSULTATION
Study
Participants
Interventions
Outcomes
Foley 1994
N=70
Patients requiring partial or total nail
avulsion
Group 1: Calcium sodium alginate dressing (Kaltostat)
n=35
Group 2: Non adherent dry dressing (Melolin) n=35
Outcomes:
•
Healing by a 9 point criteria list
•
Post operative infection and other complications
•
Patient ratings for comfort, acceptability and
pain.
Follow up: Until healing
Setting: Nail
surgery unit
United
Kingdom
Results:
(Days) Mean time to healing (SD)
Group 1: 25.8 (12.9)
Group 2: 34.4 (15.2)
Infection
Group 1: 1/35
Group 2: o/35
Number of dressing changes
Group 1: 3.6 (1.8)
Group 2: 4.5 (2.2)
Surgical site infection: full guideline DRAFT (April 2006)
Page 510 of 599
DRAFT FOR CONSULTATION
D23:PIN SITE CARE
Clinical Effectiveness
Study
Henry 1996
Population
3 groups
n=30 pts (120 pins, 40 in each
group)
age: 11-18 y
sex: females
surgery: mostly limb lengthening in
the femur or tibia
Pins located on the femur or tibia
Interventions
All groups had crust removal, povidone-iodine
spray and dry gauze dressing.
Group 1: daily cleansing with 0.9% saline with
gauze.
Group 2: daily cleansing with 70% alcohol with
gauze.
Group 3: no solution cleansing.
Duration of pin site care (pins in place): 56 to
244 days (mean 150 days)
Outcomes
Outcomes: Infection rates
Measurement tools: combination of clinical signs and culture counts >
100,000 organisms/gm
Results:
Infection rates:
Group 1: 25% ;
Group 2: 18 %;
Group 3: 8%
Infection rate was 35% higher in femoral sites than tibial ones
92% of positive cultures were S.aureus
W-Dahl
2003
2 groups
n=50 pts (400 pins, 4 pins per
person)
Group 1: 23 pts
Group 2: 27 pts
mean age: 54 y (35-72)
sex: 19 females
Patients undergoing surgery for
gonarthrosis by the hemicallotasis
technique
All patients followed the same pin site care
protocol (crust removal, cleaning with 0.9%
saline)
Group 1: daily pin site care
Group 2: weekly pin site care
All patients given IV antibiotic prophylaxis during
surgery, followed by 14 days of oral use, if any
sign of a pin site infection occurred, additional
antibiotic treatment was started
Duration of pin site care (pins in place): mean 99
days (SD 24)
Group 1: mean 103 (SD 29)
Group 2: mean 95 (SD 18)
After completion of the trial neither of the experimental regimes adopted
Outcomes:
Primary: Infection rates
Secondary: analysis of pain, use of antibiotics
Measurement tools:
Checketts-Otterburns infection classification,
Bacterial cultures at week 1,6,10
Pain assessment on Visual Analogue Scale (VAS)
Results:
No differences between daily and weekly pin site care in frequency of
infection rates, severity of infections, frequency of positive bacterial
cultures (except in week 6, p=0.02), pain and in use of antibiotics or
analgesics.
Mean infection rate:
Group 1: 14 % grade I, 4% grade II; Group 2: 10% grade I, 3% grade II
Use of antibiotics:
Group 1: mean 53 days (SD 22); Group 2: mean 41 days (SD 30)
Surgical site infection: full guideline DRAFT (April 2006)
Page 511 of 599
DRAFT FOR CONSULTATION
D24:TREATMENTS
Clinical Effectiveness
Study
Trial patients
Interventions
Outcome measures
Study: AlWaili 1999
Population: Women with severe acute post
operative wound infection
Eligibility criteria: Women with
bacteriologically confirmed infections, fever,
anorexia and local signs and symptoms
including redness, pain, tenderness, serous
or mucopurulent discharge 5-7 days after
abdominal hysterectomy or caesarean
section
Crude Yemeni honey 12 hourly applications
(n=26; 100% completed)
Primary outcomes: None stated
Secondary outcomes: Daily bacteriological wound
culture, clinical subjective assessment of wound, length
of stay, antibiotic use
Setting:
United Arab
Emirates
Centres:
dns
Years: dns
Sample
size: 50
Study: Kiani
1991
Setting:
USA
Centres: 22
Types of infections: All with bacteriologically
confirmed wound infection
Age: Mean 27.4 years
Baseline comparability: No gross imbalances
noted
Population: Men and women with acute skin
and skin structure infections.
Eligibility criteria: Outpatients and inpatients
with suspected acute skin and skin structure
infections. Excluded if other antibiotic within
72 hours of study start or concomitant
steroids used.
Antiseptics (70% ethanol and povidone-iodine) 12 hourly
applications
(n=24; 100% completed)
Study duration: Up to 31 days
Concomitant treatment: All patients received systemic
antibiotics, flucloxacillin, gentamycin and tobramycin. The
antiseptic group also received amoxicillin.
Azithromycin OD for 5 days (500 mg on day 1, followed
by 250 mg on days 2 to 5)
(n=182; 45.6% completed)
Cephalexin 500 mg BID for 10 days
(n=184; 52.2% completed)
Study duration: 30 days
Years: dns
Sample
size: 366
Types of infections:
Abscess: azithromycin-42%; Cephalexin-45%
Cellulitis: 26% and 26%
Impetigo: 6% and 4%
Infected wound: 6% and 9%
Other skin infections: 7% and 9%
Primary outcome: None stated
Secondary outcomes: Clinical response rated as: cured if
signs and symptoms of infection resolved during the
study with no evidence of infection at day 11; improved if
subsidence of signs and symptoms during the study with
incomplete resolution by day 11; failed if no apparent
clinical response at day 11. Bacteriological response
(elimination of the initial causative pathogen by day 11;
healing of the infection site(s) and the absence of an
appropriate source of sampling for culture). Adverse
events.
Age: Mean 38.6 years; Range 16 to 92 years
Surgical site infection: full guideline DRAFT (April 2006)
Page 512 of 599
DRAFT FOR CONSULTATION
Study
Trial patients
Interventions
Outcome measures
Korpan
1995
Population: Hospitalised patients with postoperative wound infections
Continuous microwave treatment, one 30 minute session
OD for 7 days
(n=71)
Setting:
Ukraine
Eligibility criteria: Patients with purulent
wounds and inflammatory infiltrates after
abdominal surgical operations for
inflammatory diseases of the bile ducts,
gallbladder, pancreas, appendix, as well as
after herniotomy.
Primary outcome: None stated
Outcomes: Wound healing (initial epithelization, wound
clearance, granulation appearance, daily decrease of
wound surface area (estimation was based on wound
surface imaging by means of cellophane film) and
hospital days). Bacterial dissemination of purulent
wounds (determined by the content of microorganisms
per 1 g of tissue). Pain (using standardized
questionnaire, ordinal scale, 3 levels).
Centres: 1
Years: dns
Placebo, one 30 minute session OD for 7 days
(n=70)
Did not report the number completing
Study duration: 15 days
Sample
size: 141
Age: Mean 50.6 years; Range 31 to 83 years
Baseline comparability: no imbalances
reported
Study:
Kraus 1998
Population: Outpatients with infected small
lacerations, abrasions or infected wounds
Eligibility criteria: Patients of any age
presenting with secondarily infected wounds
that could be treated with either intervention;
SIRS total score of at least 8; positive Wright
stain for white blood cells from wound
exudate; laceration or sutured wound could
not have exceeded 10 cm in length with
surrounding erythema no more than 2 cm
from the edge of the lesion; abrasions could
2
not exceed 100 cm in total area with
surrounding erythema no more than 2 cm
from the edge of the abrasion.
Setting:
USA
Centres: 53
(2 trials
pooled)
Years:
August
1994 to
June 1996
Sample
size: 706
Concomitant treatment: Radical surgical cleaning of the
wounds was regularly performed (washed all wounds
with antiseptic solutions, dressed daily, pus-infiltrated
necrotic and non-viable tissue was removed every 2 or 3
days. Received local therapy and symptomatic
treatment.
Mupirocin calcium cream (2% mupirocin) applied to cover
entire wound TID for 10 days
(n=357; 89% completed)
Cephalexin 250 mg oral (capsule or suspension)QID if >
40 kg, 25 mg per kg of body weight per day if ≤ 40 for 10
days
(n=349; 90% completed)
Study duration: 17 to 22 days
Age: Mean 35.2 years; Range 0.03 to 92
years
Baseline comparability: no imbalances
reported
Surgical site infection: full guideline DRAFT (April 2006)
Primary outcome: Clinical response: persistent clinical
success (defined as complete resolution or sustained
improvement of signs and symptoms of infection with no
exudate or pus present in wound and no additional
antibiotics required; clinical recurrence (defined as
reappearance or worsening of the signs and symptoms of
infection that required additional antibiotic therapy);
unable to determine (defined as inability to make a valid
assessment of clinical outcome).
Secondary outcomes: Bacteriologic response: persistent
presumed eradication (defined if symptomatic response
was a success and culture was not clinically indicated);
reinfection (defined as pretherapy pathogen eradicated
but one or more new pathogens appeared during followup period); relapse (defined as initial pathogen eliminated
during therapy but reemerged during follow-up period);
unable to determine (defined as bacteriologic evaluation
could not be made). Patient preference/acceptance.
Safety.
Page 513 of 599
DRAFT FOR CONSULTATION
Study
Trial patients
Interventions
Outcome measures
Liu 1995
Population: Hospitalised Patients with
complicated skin and soft tissue infections
Eligibility criteria: Patients with infected ulcers
or wounds, major abscesses or significant
underlying diseases such as diabetes and
peripheral vascular disease; ≥ 18 years;
postmenopausal ≥ 1 year or negative serum
pregnancy test if female
IV imipenem-cilastatin 500 mg every 6 hours followed by
oral ciprofloxacin 750 mg every 12 hours
(n=15; 100% completed)
Primary outcome: None stated
Secondary outcomes: Response to treatment rated as
cured or improved, no definitions given, bacterial cultures
Setting:
USA
Centres:
Presumed
single
centre
Years: dns
Sample
size: 31
Study:
Mallory
1991
Setting:
USA
Study duration: At least 3 days for response analysis
Types of infections:
Proportions of patients with each infection not
given
Sample
size: 363
Two patients excluded from all results, does not state
which group(s) they belonged to.
Age: At least 18 years
Baseline comparability: dns if there were
baseline imbalances or not
Population: Men and women with acute skin
and skin structure infections.
Eligibility criteria: Male and female patients
presenting with acute skin or skin structure or
wound infections; at least 16 years of age.
Excluded if other antibiotic within 72 hours of
study start
Centres: 25
Years: dns
IV levofloxacin 500 mg every 12 hours, followed by oral
levofloxacin at the same dose
(n=14; 100% completed)
Azithromycin OD for 5 days (500 mg on day 1, followed
by 250 mg on days 2 to 5)
(n=240; 42.5% completed)
Cephalexin 500 mg BID for 10 days
(n=121; 38% completed)
Study duration: 30 days
Types of infections:
Abscess: azithromycin-16%; Cephalexin-12%
Cellulitis: 16% and 32%
Impetigo: 2% and 1.6%
Infected wound: 3% and 2.5%
Other skin infections: 5.4% and 3.3%
Two patients excluded from all results as did not take any
medication and lost to follow-up. Does not state which
group(s) they belonged to.
Primary outcome: None stated
Secondary outcomes: Clinical response (determined by
assessing clinical parameters of fever, pain at infection
site or sites, lymphadenitis, erythema, swelling and
production of exudate): cured if signs and symptoms of
infection resolved during the study with no evidence of
infection at day 11; improved if subsidence of signs and
symptoms during the study but with incomplete resolution
by day 11; failure if no apparent clinical response at day
11.
Bacteriological eradication defined by elimination of initial
causative pathogen by day 11. Adverse events.
Age: Mean 39.7 years; Range 16 to 95 years
Baseline comparability: dns if there were
baseline imbalances or not
Surgical site infection: full guideline DRAFT (April 2006)
Page 514 of 599
DRAFT FOR CONSULTATION
D25: PATIENT VIEWS, EXPERIENCES AND INFORMATION NEEDS
Author
Bradshaw
1999
UK
Study Design
Objective
Cross-sectional
Identify key areas of
concerns for patients
post-op
Setting
Daysurgery
Population
Characteristics
Day-surgery patients
Following 3 mo after op
Age-18-65 years
N=60
Methods
Questionnair
e
Outcome
Measures
OM: key areas
of concerns
following
surgery
Develop a consensus
of advice for post-op
patients
Fitzpatrick
1998
UK
Cross-sectional
Examine patients’
experiences of postoperative pain, fatigue
and wound healing
following varicose vein
and arthroscopy day
surgery
Evaluate satisfaction
with information
received following
discharge
Results
Reviews of a sample of postop leaflets revealed that it is
filled with jargon, can be
imprecise or difficult to read
Patients listed the following
key areas of concern in the
rehab period:
Post-op pain, wound
problems, bathing, stretching
and heavy exercise, return
to work, driving and sex.
Day
surgery
Day surgery patient
N=30
Follow-up 7 days after
op
Age range:18-374years
Male=13 Female=17
Surgical site infection: full guideline DRAFT (April 2006)
Telephone
interview
OM:
Experience of
pain and
wound healing
Satisfaction
with
information
provided
Pts indicated that the
information received were
satisfactory re: wound
healing(93% , and pain
management(97%) on
recovery from surgery.
Pts indicated that information
on duration of recovery
would also be of help.
Comments
Quality Issues
The consensus of advice from
surgeons used a ‘normal’ patient,
i.e not exhibiting problems with
wound healing so that part of the
study was not very revealing.
The development of the
questionnaire was of good quality
as it was developed after two sets
of interviews and was piloted first.
Limited generalisability as patients
selected from a select set of
surgical procedures
Exclusion criteria not stated or
patient characteristics e.g. if any
had suffered from wound
infection
The time period for follow-up was
only 7 days, which may not have
been adequate time to assess
wound healing
Limited generalisability as focus
on only two types of surgery and
interview was conducted over the
telephone.
Pts cited information
leaflets(76%) followed by
nurses(73%) and doctors to
be their sources of
information.
Page 515 of 599
DRAFT FOR CONSULTATION
Author
Persson
1995
Sweden
Study Design
Objective
Randomised
Identify patients’
attitudes to wound care
Setting
University
hospital
Perencevich(
2003)
USA
Case-control
Measured the changes
in physical and mental
health component
scores in cases with
SSI and controls
Hospital
(Inpatient
&
Outpatient)
Whitehouse
2002
USA
Case-Control
Measure impact of SSI
on QoL, length of stay
and costs
University
medical
centre and
community
hospital
Population
Characteristics
N=68 pts randomised
following abdominal
operation with ‘cleancontaminated wounds’
N(excl)=8
Final N(dressing)
Male=15
Female=16
Final N(exposed)
Male=11
Female=19
Cohort N=267
Cases=89
Male=43
Female=46
Age: 55.8+/-14.6
Controls=178
Male=94
Female= 84
Age=57.5+/-13.3
F/up: 8 weeks
Cases & Control
N=59 in each
F/up:1 year
Surgical site infection: full guideline DRAFT (April 2006)
Methods
Visual
analogue
scale
&
questionnaire
Outcome
Measures
I: Dressing
v. exposed
OM: attitude
to method of
wound care
Results
No significant differences
were found between the two
groups re: questions on
thoughts about wound and
post-op pain. (p>.03)
No significant differences
were found between age
groups(<40 v >40), genders.
Comments
Quality Issues
The patients were in the ward
upto 5 days only and were
enrolled consecutively. It is
unclear whether the person who
allocated them into the group, was
the same as the one who
assessed the wounds or
administered the questionnaire.
65% of the ‘dressed’ wounds
group and 87% of the
‘exposed’ group would prefer
the same method for
subsequent operations.
SF-12
OM: HRQoL
QoL:SF-36
scale
OM: QoL
Only 2 incidences of wound
infection were reported.
HRQOL scores indicated
that pts with SSI significant
decline in the mental health
domain of the SF-12(p=.004)
The results indicate that in
comparison to controls, pts
with SSIs have significant
decrease in QoL particulary
in the physical functioning
and role-functioning
domains(p=.014 and p=.02)
Patients were asked to assess
their HRQoL for 4 weeks
preceding the surgery. However,
the data was collected
retrospectively. Although there
was no significant difference
between the cases and control for
the pre-operative scores, it is
unclear how accurate
retrospective assessments are.
The study had a follow-up period
of 1 year which is a possible
reason for the low participation
rate(<80%)
Patients matched on type of op,
surgeon, age+/- 5 years. No
breakdown of ages or gender.
Page 516 of 599
DRAFT FOR CONSULTATION
Author
Aim
Method
Franks
1999
Examines the importance
of quality of life issues in
chronic wound
management
Examines the importance
of consider the physical
and psychological
aspects of wounds when
developing care plans
Explore the meaning of
living with a non-healing
wound
UK
Hack 2003
UK
Neil 2000
USA
Setting
Findings
Conclusions
Review
Population
-
-
Quality of life is low for patients suffering from
chronic wounds
The benefit of a disease specific tool v. generic tool
to assess QoL is discussed. The results indicated
that disease specific tools have better chance of
assessing the impact
Review
-
-
Living with a chronic wound can result in a altered
body image, feeling of rejection, shame or
embarrassment due to the malodour. This can also
result in social withdrawal and inhibition of sexuality.
Semistructured
interviews
N=10
Male-4
Female6
In-patient
hospital
units
Outpatient
wound
healing
clinics
The two main emerging themes were:
-contending with the wound & staying home
The ‘contending with the wound’ theme revealed that
the psychological effects of managing an oozing and
smelling wound can cause distress and
embarrassment. The physical presence of the
wound and how it was ‘noticed’(either by themselves
or a partner) can also be a source of distress.
The impact on QoL due to chronic
wounds may be a better indicator
than clinical endpoints. Disease
specific tools have greater ability to
accurately assess the impact on
QoL. Although disease specific tools
are available for leg ulceration tools
for other types of wounds need to be
considered.
The effect on both patient and carer
must be considered. In order to
improve adherence the patient must
be involved in the generation of the
care plan.
The study provides an account of
everyday lived experience of people
suffering from chronic wounds.
Participants also revealed problems encountered
sleep deprivation and being in pain.
It highlights the need to consider
involving family members or carers in
helping a pt comply with wound
management strategies. Health
professionals should also consider
information needs of carers.
The theme of ‘staying home’ revealed the social
effects of living with a chronic wound. A sense of
isolation is brought on due to changes in daily
activities.
The contribution from partners/carers in the interview
procedure exemplifies their role in contending with
the chronic wound.
Surgical site infection: full guideline DRAFT (April 2006)
Page 517 of 599