The Science of a “Seal” for
PICC Line Management:
An Alternative Hemostatic Agent That
Keeps Sites Dry and Intact
Lauren Blough, RN, BS, CRNI;
Kathy Hinson, RN, MN, MBA, MPH; Louis M. Guzzi, MD, FCCM
Disclosures
Lauren Blough, RN, BS, CRNI has the following
disclosures:
• Lauren provides paid consulting services to Biolife,
LLC, product manufacturer
• Biolife LCC is providing payment for
author/presenter’s travel and lodging expenses
There is corporate support for this session. Biolife’s
financial support has made this session possible.
Introduction
The Venous Access Services (VAS) team of
Florida Hospital identified an alternative
hemostatic agent for PICC line management
to improve patient outcomes and achieve
time and financial savings.
Background
Prior to study, the VAS team was:
 Using a gauze wick on every PICC
site to control bleeding
 Using oxidized cellulose gauze in
approximately 20% of cases (for
problematic bleeding)
 Changing dressings at 48 hours
Prior to study - Soiled dressing at
insertion site.
CDC Guidelines
Guidelines for the Prevention
of Intravascular CatheterRelated Infections
Replace catheter-site dressing if the
dressing becomes damp, loosened, or
visibly soiled (146,210). Category IB
Current Study of CHG Sponge
Chlorhexidine-Impregnated Sponges and Less
Frequent Dressing Changes
Jean-François Timsit, MD, PhD (March 2009)
 Decreased the risk of major CRBSIs by 60%
 “However, unscheduled dressing changes
for soiling and leakage were common.”
(40-50% unplanned)
Make it Easy!
“Prevention of CRBSI: Make it easy
to do the right thing and make it
hard to do the wrong thing.”
Faisal Masud M.D., FCCP
Medical Director,
Cardiovascular Intensive Care Unit
Methodist DeBakey Heart Center
Multiple, unplanned dressing changes are not “easy”.
How We Got Started
 August 2007
– ED presented to our product committee
– Approved for use in ED for un-sutureable wounds
 VAS saw the potential for PICC on insertion
 Approved for an evaluation
 Prior to this BioSeal had only been used on line removals: JVIR
study*
Powder
Time to Hemostasis
following Venous
Access Procedures
1.93 min
Control
3.96 min
Time Saved
2.0 min
*Wang, D.S., Chu, L.F. , et al. 2008. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial,
Venous, and Arteriovenous Dialysis Access Procedures. Journal of Vascular and Interventional Radiology
How We Got Started
 Education began to the VAS team at FH
Orlando
 Product reps trained and precepted EVERY
PICC nurse on VAS team with three clinical
applications- 26 nurses at the time
Purpose of Study
To assess the ability of an alternative
hemostatic agent to achieve hemostasis
for PICC line insertions and to eliminate
the 48 hour dressing change.
What is BioSeal CVC?
A topical powder made of a
hydrophilic polymer and a
potassium ferrate.
BioSeal CVC Powder
The powder’s mechanism of
action forms an occlusive
seal to protect an access site
and keep it dry and intact.
Colorized scanning electron microscopy
The Seal
The seal created by the
powder allows “nothing in,
nothing out”.
 Keeps microbial nutrients from
getting out
 Prevents microbes from
getting in
 Minimizes unscheduled
dressing changes meaning less
exposure to potential microbes
Seal
Extra
powder
SEM photography of a 5 Fr.
Catheter. Note the occlusive seal
that has formed around the line.
The Seal
Above the Seal
1. Bacteria full of water and salts come in
contact with the powder on the top side of
the seal (H2O & Ca++, Na+, K+)
2. The bacteria dries.
3. The moisture pulled from the bacteria contain
salts. The cations of these salts are exchanged
for H+ (acidic), creating a low pH environment
(~2) above the seal.
Desiccation + Low pH (~ 2) = Microbial Barrier
Below the Seal
The powder floats on the blood – it doesn’t
penetrate the seal. This results in a neutral pH below
the seal.
5 Fr catheter
The Powder as a Microbial Barrier
Microbial Strike-Through (Barrier) Test Results*
7-days Incubation
S. aureus MRSA ATCC 33591a
S. epidermidis MRSE ATCC 51625
E. faecalis VRE ATCC
51575 a
S. aureus ATCC 6538
b
P. aureginosa ATCC 9027
E. coli ATCC 8739
b
b
C. albicans ATCC 10231
A. ATCC 16404
a
b
b
Test Sample
Control
NG
G
NG
G
NG
G
NG
G
NG
G
NG
G
NG
G
NG
G
7-Day with Daily Rechallenge Test Results*
MRSA ATCC 33591
VRE ATCC 51575
MRSE ATCC 51625
Sample
Control
Sample
Control
Sample
Control
2.1 x 106
2.2 x 106
3.4 x 106
3.1 x 106
1.7 x 106
1.8 x 106
After 24 hours
After 48 hours
>5.3
>5.3
NR
NR
>5.5
>5.5
NR
NR
>5.2
>5.2
NR
NR
After 72 hours
>5.3
NR
>5.5
NR
>5.2
NR
After 96 hours
>5.3
0.2
>5.5
NR
>5.2
0.3
After 120 hours
>5.3
0.3
>5.5
NR
>5.2
0.3
After 144 hours
>5.3
NR
>5.5
NR
>5.2
0.4
After 168 hours
>5.3
NR
>5.5
NR
>5.2
NR
CFU at Initial
Contact
Log Reduction
* Data not evaluated by the Food and Drug Administration.
BioSeal vs. CHG Products
BioSeal CVC
CHG Products
 Engineers the human error  In disc form, can be applied
out of the process –
incorrectly
applying powder and
 In gel and disc form, absorbs
dressing site at insertion
fluid which dampen dressing
keeps sites dry and intact
requiring a dressing change
for 7 days.
 Studies show that
 Eliminates 48 dressing
unscheduled dressing
change and unplanned
changes are required 40-50%
dressing changes.
of the time due to reaching
 Cost-effective; can replace
maximum absorption levels
hemostats and infection
control products
Study Methods
Type of study
 Observational Study
 Convenient Sample
During a 39-day period, BIOSEAL CVC™ Powder was evaluated for all PICC
line insertions (418) and for occasional bleeding at dressing changes or
line discontinuations.
Following product application, staff completed written evaluations to:
 Rate the efficacy of the powder as compared to the controls, gauze
and oxidized cellulose gauze
 Record time to hemostasis
A post-hoc assessment of potential complications such as infections,
bleed through, skin-impressions or rash due to product use was also
conducted.
Major Outcomes
 98% of respondents considered the powder effective
for controlling PICC line access site bleeding
Product Effectively Stops Bleeding
Rating and No. of Responses
(scale 1-6, 1=poor, 6=excellent)
44%
Rating
5
38%
12%
# of responses
4%
3
1
0
50
100
150
200
# of Responses
 The powder effectively stopped bleeding in ≤ 2 minutes
in 94% of applications.
Major Outcomes
 ~40% reduction in Catheter-related
Bloodstream Infections (CRBSIs) according to
a post-hoc review of documentation
 No site infections or other complications
 Skin integrity was ‘pristine’.
 Reduced cost:
- Powder vs. cellulose gauze
- Reduced frequency of dressing changes
- Reduced time at the bedside with
troubleshooting bleeding and oozing PICC line
sites
Major Outcomes
 79% of patients evaluated had high PT/INR
levels at the time of powder use
– Effective hemostasis
 Patient acuity did not change the effectiveness
of the seal
– 85% of insertions are in upper level/ICU patients
Conclusions
 Results demonstrated an overwhelming user-preference
for the powder relative to the gauze control standard of
care.
 The product was considered to be effective in controlling
PICC line access site bleeding. There was no difference in
efficacy based on patient demographics or concomitant
drug therapies.
 Extended post trial use of the product demonstrated the
complete elimination of the 48-hour dressing change and
a significant decrease in CRBSIs.
Implications for Practice
Florida Hospital has eliminated the 48-hour
dressing change and added BioSeal CVC
Powder to PICC line insertion protocol and
now perform initial dressing change at 7 days.
In addition to a decrease in CRBSIs, the
hospital has realized efficiencies through:
 Decreased nursing time
 Cost savings (fewer dressing kits)
 Perceived patient comfort (fewer site
manipulations and complications).
Insertion site with BioSeal CVC Powder
Dry/intact dressing – 0-7 days
Implications for Practice
Procedural Cost Analysis
Cost/Benefit Analysis
Nursing Cost Per Hour
Hours per work shift
# dressing changes per Hour
Average # dressing changes per work shift
Nursing cost for dressing change
Surgicel
BioSeal
$43.17
Savings
$43.17
12
2
24
$21.59
$21.59
Average cost of dressing change kit
$4.77
$4.77
Total Cost of Nursing time per Hour
$26.36
$26.36
$58.00
$20.00
20%
100%
Total Cost if Bleeding Complications:
$11.60
$20.00
Cost of Dressing Change after 24 Hours
$26.36
0
Total Cost of Patient Care
$64.32
$46.36
500
500
$32,160.00
$23,180.00
$8,980.00
$385,920.00
$278,160.00
$107,760.00
If Bleeding Complications:
Cost of additional products:
% of time additional products use:
# of PICCS/Month
Cost Per Month
Cost Per Year
-$8.40
$17.96
Implications for Practice
Next Steps for Florida Hospital:
 Air Embolism Prevention: use the powder on all
central line removals, not PICC (implemented
March 2010)
 Place on all central line insertions in addition to
PICC
Publication of Study
 Study was one of four podium
presentations selected for the at
Association of Vascular Access
(AVA) Annual Conference,
September 2009
 Also presented in poster format at
the same conference
 Published in the Journal of the
Association of Vascular Access
(JAVA), Summer 2010, 15:2, 66-73.
Powder Application
 Application training is key
 Use of the PCD
Forms a ‘pill’, edges as deep as
the center
 Powder properties, flow out
 Leave the PCD in place, cover
with dressing
Application and Removal
 Removal
– Naturally falls off at approx. 7 days
– Can be removed with NS
 Line Removal and ‘THE TUG’
– One of the ‘ah-ha’ moments
– Seal that exists around the line in the skin tract
Questions?