3M Tegaderm Ag Mesh Dressing with Silver Product Profile

3M™ Tegaderm™ Ag Mesh Dressing with Silver
Product Profile
Tegaderm Ag Mesh
™
Dressing with Silver
Delivering the
Power of Silver
3M set out to create a dressing with the proven barrier
protection of antimicrobial ionic silver that is versatile,
easy-to-use and affordable. We surveyed clinicians and
identified the following key performance criteria, which
are detailed on the facing page.
EFFECTIVE
SAFE
EASY-TO-USE
VERSATILE
COST-EFFECTIVE
Health care professionals around the globe already look
to 3M for innovative solutions that reduce the risk of
infection, provide better patient outcomes and reduce
health care costs. Now they can look to us for a better
choice in silver dressings, too.
3M™ Tegaderm™ Ag Mesh Dressing with Silver.
Why use 3M™ Tegaderm™ Ag Mesh Dressing with Silver?
TegadermTM Ag Mesh Dressing meets the key performance criteria identified by clinicians:
Effective*
Fast-acting antimicrobial load reduction
Long-term antimicrobial barrier
Effective against a wide range of microbes, including antibiotic-resistant bacteria (MRSA and VRE)
Effective against yeast and fungi
Versatile
May be used as a primary dressing
May be used with absorbent wound fillers
May be used in undermined and tunneled wounds
Compatible with other 3M advanced wound care products
Multiple sizes
Easy-to-Use
Porous
Conformable
Can be cut, folded or fluffed
Safe
Non-irritating
No to minimal skin or wound staining
Effective up to seven days
Safe to use with sterile normal saline, sterile water and liquid hydrogels
Cost-Effective
Value priced
Versatility reduces number of silver products needed
*Based on standard in vitro microbiological methods.
1
Ionic silver works three ways to control bacteria
Clinical literature shows silver ions reduce microbial load through multiple mechanisms of action. This literature
suggests that the risk of microorganisms becoming resistant to ionic silver is minimized because of silver’s ability
to destroy microbes in these ways:1
The silver ions react with
the cell’s DNA, prohibiting
reproduction.2
3M™ Tegaderm™ Ag Mesh Dressing
releases ionic silver rapidly and over time.*
Particles of silver sulfate are coated
on the surface of cotton fibres in the
Tegaderm™ Ag Mesh Dressing.
When wound exudate, sterile normal saline,
sterile water or liquid hydrogel comes into contact with
the dressing, the silver sulfate dissolves, releasing
silver ions in the dressing rapidly and over time.
*Based on standard in vitro microbiological methods.
2
The silver ions enter the
cytoplasm and bind with enzymes that
control respiration. The enzymes shut
down, suffocating the cell.2,3,4,5,6
The silver ions bind to the cell
wall, causing lysis.7,8
In vitro efficacy against virulent pathogens
3M™ Tegaderm™ Ag Mesh Dressing contains silver sulfate, one of the most soluble forms of ionic silver.9
When moistened, antimicrobial silver ions are released in the dressing to begin reducing the number of pathogens
within minutes – including many of the most virulent bacteria, such as MRSA and VRE. Tegaderm™ Ag Mesh Dressing
continues to provide sustained antimicrobial barrier control over seven days.
It inhibits the following strains of microbes:10
Aerobic
Acinetobacter sp.
Aeromonas hydrophila
Alcaligenes sp.
Bacillus cereus
Bacillus circulans
Bacillus licheniformis
Bacillus pumilus
Bacillus subtilis
Burkholderia cepacia
Citrobacter amalonaticus
Citrobacter diversus
Citrobacter freundii
Citrobacter koseri
Corynebacterium minutissimum
Enterobacter aerogenes
Enterobacter agglomerans
Enterobacter cloacae
Enterococcus avium
Enterococcus durans
Enterococcus faecalis
Enterococcus faecium
Enterococcus hirae
Enterococcus raffinosus
Escherichia coli
Escherichia vulneris
Klebsiella ornithinolytica
Klebsiella oxytoca
Klebsiella pneumoniae
Klebsiella pneumoniae
subsp. ozaenae
Listeria monocytogenes
Moraxella (Branhamella)
catarrhalis
Pasteurella aerogenes
Proteus mirabilis
Proteus hauseri
Proteus vulgaris
Providencia alcalifaciens
Providencia rettgeri
Anaerobic
Yeast and Fungi
Providencia stuartii
Pseudomonas aeruginosa
Pseudomonas alcaligenes
Pseudomonas fluorescens
Pseudomonas luteola
Pseudomonas stutzeri
Salmonella montevideo
Salmonella typhimurium
Serratia marcescens
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus lugdunensis
Staphylococcus saprophyticus
Staphylococcus schleiferi
Staphylococcus xylosus
Streptococcus mitis
Streptococcus pyogenes
Antibiotic-Resistant
(both aerobic and anaerobic)
Bacteroides fragilis
Clostridium clostridioforme
Clostridium perfringens
Clostridium ramosum
Peptostreptococcus anaerobius
Tissierella praeacuta
Aspergillus fumigatus
Aspergillus niger
Candida albicans
Candida glabrata
Candida krusei
Candida tropicalis
Saccharomyces cerevisiae
Enterococcus faecalis (MDR)
Enterococcus faecium (VRE)
Staphylococcus aureus (MRSA)
Staphylococcus epidermidis (MRSE)
Stenotrophomonas maltophilia
3
Fast-acting against the most challenging pathogens
Methicillin Resistant
Staphylococcus aureus
(MRSA)
9
8
7
6
(Log10 CFU)
Microbial Load
Pathogens can multiply rapidly in
a wound, so quick microbe
reduction is important to wound
management. Based on standard
laboratory time-kill assays,
3M™ Tegaderm™ Ag Mesh Dressing
reduced the number of pathogens
– including common, drug-resistant
bacteria – rapidly over two hours.11
In statistical comparisons,
the performance of Tegaderm™
Ag Mesh Dressing at 120 minutes
was comparable to that of the
leading fast-acting silver dressing,
and exceeded the performance of
several other silver dressings.12
5
Aquacel ®Ag
4
Silvercel®
3
SilvaSorb® Gel
2
SilvaSorb®
1
0
Acticoat™ Burn
20
40
60
80
100
120
3M™ Tegaderm™
Ag Mesh Dressing
Time (minutes)
Vancomycin Resistant
Enterococcus faecium
(VRE)
9
8
7
(Log10 CFU)
Microbial Load
6
5
Silvercel®
4
SilvaSorb® Gel
3
Aquacel®Ag
2
SilvaSorb®
1
0
20
40
60
80
Time (minutes)
4
100
120
3M™ Tegaderm™
Ag Mesh Dressing
Acticoat™ Burn
Methicillin Resistant
Pseudomonas aeruginosa
Staphylococcus epidermidis
9
8
8
7
7
6
6
Silvercel®
4
SilvaSorb® Gel
3
Aquacel®Ag
2
SilvaSorb®
1
0
20
40
60
80
100
120
3M™ Tegaderm™
Ag Mesh Dressing
Acticoat™ Burn
(Log10 CFU)
5
Microbial Load
(Log10 CFU)
Microbial Load
(MRSE)
9
5
Aquacel®Ag
4
Silvercel®
3
SilvaSorb®
2
SilvaSorb® Gel
3M™ Tegaderm™
Ag Mesh Dressing
Acticoat™ Burn
1
0
20
Time (minutes)
40
60
80
100
120
Time (minutes)
Multidrug Resistant
Candida albicans
Enterococcus faecalis
9
9
8
8
7
7
6
6
Silvercel®
4
SilvaSorb Gel
®
3
SilvaSorb®
2
Aquacel®Ag
1
0
Acticoat™ Burn
20
40
60
80
Time (minutes)
100
120
3M™ Tegaderm™
Ag Mesh Dressing
(Log10 CFU)
5
Microbial Load
(Log10 CFU)
Microbial Load
(MDR)
5
Silvercel®
4
SilvaSorb® Gel
3
SilvaSorb®
2
Aquacel®Ag
1
0
3M™ Tegaderm™
Ag Mesh Dressing
Acticoat™ Burn
20
40
60
80
100
120
Time (minutes)
5
Long-term microbial suppression for added effectiveness
Long-term suppression of wound microbes minimizes pathogen regrowth and possible interference with wound
healing.14 Based on an in vitro time-kill assay with longer exposure times, 3M™ Tegaderm™ Ag Mesh Dressing
demonstrated extended effectiveness with sustained microbial reduction over 14 days. The performance was
comparable to that of a leading long-lasting silver dressing.13,14
Methicillin Resistant
Vancomycin Resistant
Staphylococcus aureus
Enterococcus faecium
(VRE)
8
7
7
6
6
Microbial Load
5
4
(Log10 CFU)
(Log10 CFU)
Microbial Load
(MRSA)
8
3
2
1
0
Aquacel® Ag
1
2
3
4
5
6
7
8
9
10 11 12 13 14
3M™ Tegaderm™ Ag
Mesh Dressing
5
4
3
2
1
0
Aquacel® Ag
1
2
3
4
5
6
Time (days)
7
6
6
4
3
2
Aquacel Ag
®
2
3
4
5
6
7
8
9
10 11 12 13 14
Time (days)
6
3M™ Tegaderm™ Ag
Mesh Dressing
(Log10 CFU)
5
Microbial Load
(Log10 CFU)
Microbial Load
8
7
1
9
10 11 12 13 14
3M™ Tegaderm™ Ag
Mesh Dressing
Bacteroides fragilis
8
0
8
Time (days)
Pseudomonas aeruginosa
1
7
5
4
3
2
1
0
Aquacel® Ag
1
2
3
4
5
6
7
8
9
10 11 12 13 14
Time (days)
3M™ Tegaderm™ Ag
Mesh Dressing
Efficacy in controlling varied wound flora
The following in vitro zone of inhibition studies15 demonstrate the effectiveness of 3M™ Tegaderm™ Ag Mesh Dressing in
controlling varying populations of bacteria – both from laboratory samples and from wound exudate isolates of patients with
non-healing wounds.
In vitro assays with pure microbial cultures
Agar
TegadermTM Ag Mesh Dressing
Zone of Inhibition
Staphylococcus aureus
(MRSA)
Staphylococcus
epidermidis (MRSE)
Pseudomonas
aeruginosa
Using in vitro assays (a modification to the Kirby-Bauer disk diffusion antibiotic susceptibility test16,17), Tegaderm™ Ag Mesh Dressing demonstrated a 17 mm to 21 mm
zone of inhibition for three of the most common pathogens, as shown above. In these assays, an agar plate is uniformly inoculated with a test organism and a dressing
sample is placed on the agar surface. As bacteria on the plate grow, they are inhibited to varying degrees, demonstrating that the dressing can inhibit the growth of specific
microbes.
In vitro study with wound exudate isolates
PATIENT A
A male patient presented with a 1 cm by 1 cm ulcer on the left
great toe that had been present for about two months. There
was little drainage; no slough, tunneling or undermining.
Predominant microorganisms inhibited were Staphylococcus
aureus, a Gram-negative rod and a Gram-positive cocci.
Aerobic Plate
Anaerobic Plate
Aerobic Plate
Anaerobic Plate
PATIENT B
A 52-year-old male presented with a 2.5 cm by 5 cm pressure
ulcer on the left heel that had been present for about two
months. There was a moderate amount of purulent drainage,
odour, erythema and slough, but no tunneling or undermining.
Predominant microorganisms inhibited were two different
Gram-negative rods, a Gram-positive cocci, Stenotrophomonas
maltophilia, Staphylococcus cohnii, Escherichia coli,
Baccillus pumilus and Staphylococcus aureus.
Conclusion
In vitro studies show Tegaderm™ Ag Mesh Dressing has the ability to inhibit growth of bacteria from patients’ wounds.
7
The safety you demand and expect from 3M
Meets ISO standards
3M™ Tegaderm™ Ag Mesh Dressing meets ISO 10993 standards for the following:18
10993-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
10993-5: Tests for Cytotoxicity – In Vitro Methods19
10993-10: Tests for Irritation and Sensitization
10993-11: Tests for Systemic Toxicity
A safe and effective form of silver
With Tegaderm™ Ag Mesh Dressing, the surfaces of cotton fibres are coated with silver sulfate, one of
the most soluble forms of ionic silver. When the dressing is moistened, safe and effective levels of ionic
silver are quickly released, forming an effective barrier to reduce pathogens.20 Sulfate molecules naturally occur in tissue
components. Application of this dressing is not expected to significantly increase the existing level of sulfates in a wound.
There is no information to suggest that sulfite and sulfonamide (sulfa) allergic reactions
are caused by sulfate molecules.
Safe to use with sterile normal saline
Sterile normal saline may be used to moisten Tegaderm™ Ag Mesh Dressing, because it does not cause a
significant change in pH.21 When some silver dressings come in contact with saline, the pH of the saline
shifts into a caustic alkaline range that may be damaging to healing cells and has been associated with chronic
non-healing wounds.21, 22, 23
Non-staining to skin
While skin staining is not clinically harmful in and of itself, discolouration may lead to inaccurate
assessments. Some silver dressings result in substantial discolouration. Using conventional test methodology,
Tegaderm™ Ag Mesh Dressing resulted in significantly less skin discolouration.24
8
Versatile and easy for clinicians to use
Useful for many wound types
3M™ Tegaderm™ Ag Mesh Dressing is soft, non-woven and conformable. It may be used as a primary dressing over
superficial wounds or packed into wound cavities, tunnels or undermined areas. It also can be used with absorbent
wound fillers. The mesh dressing is easy to cut, allowing it to be customized to each wound bed.
Trochanter
Lower Extremity
Heel
Malleolus
Indications
Tegaderm™ Ag Mesh Dressing is indicated for use as a primary dressing on a variety of wounds, including:
• Ulcers (pressure, venous, arterial and neuropathic [diabetic])
• Open surgical wounds
• Trauma wounds
• Superficial partial thickness burns (second degree)
• Abrasions
9
Patient case study: Visible wound improvement
A 62-year-old female presented with a 27-month history of a lower extremity wound resulting from a traumatic
laceration with subsequent cellulitis. Medical history was significant for obesity and Systemic Lupus Erythematosus
with long-term immunosuppressive therapy (corticosteroids and methotrexate). The patient also had a past history
of total knee arthroplasty and there was concern for infection of the implant.
A variety of topical modalities had been attempted, including an antimicrobial enzymatic debriding agent and
non-contact normothermic therapy. Insurance issues necessitated several changes of health care providers,
leading to interruptions in wound care. While the wound bed was viable and wound edges open, the size had been
unchanged for seven months and there was an absence of healthy granulation tissue. Microbial imbalance was
suspected as a factor in the wound’s failure to progress.
3M™ Tegaderm™ Ag Mesh Dressing was applied with an expectation of controlling bioburden. The dressing was easy
to apply and versatile, allowing use with other dressing materials such as a compression wrap. It was well tolerated
by the patient without irritation, discomfort or evidence of staining. 3M™ Tegaderm™ Hydrogel Wound Filler was
used to moisten the dressing and maintain a moist wound bed. Complete healing occurred over six weeks with the
Tegaderm™ Ag Mesh Dressing helping to create an environment that promoted healing in a recalcitrant wound.
10
At admission 10/29/04
Tegaderm™ Ag Mesh Dressing applied to wound
At 7 days
Significant improvement noted.
Wound is smaller, granulation tissue evident.
At 6 weeks
Compatible with many 3M products
3M™ Tegaderm™ Ag Mesh Dressing can be safely used with the following skin and wound care products:
3M™ Tegaderm™ Absorbent Clear Acrylic Dressing
3M™ Tegaderm™ High Integrity Alginate Dressing
3M™ Tegaderm™ High Gelling Alginate Dressing
3M™ Tegaderm™ Hydrogel Wound Filler
3M™ Tegaderm™ +Pad Film Dressing with Non-Adherent Pad
3M™ Tegaderm™ Foam Dressing (nonadhesive)
3M™ Tegaderm™ High Performance Foam Adhesive Dressing
3M™ Coban™ Self-Adherent Wrap
3M™ Coban™ 2 Layer Compression System
3M™ Coban™ 2 Layer Lite Compression System
3M™ Cavilon™ No Sting Barrier Film
11
References
1. Percival SL, Bowler PG, Russell D. Bacterial resistance to silver in wound care. J Hosp Infect. 2005; May; 60(1):1-7. Review.
2. A.D. Russell and W.B. Hugo. Antimicrobial activity and action of silver, Prog Med Chem. 1994; 31:351-370.
3. P. Kaur, M. Saxena and D.V. Vadehra. Plasmid mediated resistance to silver ions in Escherichia coli, Ind J Med Res. 1985; 82:122-126.
4. J.J. Hostynek, R.S. Hinz, C.R. Lorence, M. Price and R.H. Guy. Metals and the skin, Crit Rev Toxicol. 1993; 23:171-235.
5. W.J.A. Schreurs and H. Rosenberg. Effect of silver ions on transport and retention of phosphate by Escherichia coli, J Bacteriol. 1982; 152:7-13.
6. P.D. Bragg and D.J. Rainnie. The effect of silver ions on the respiratory chain of E. coli, Can J Microbiol. 1974; 20:883-889.
7. J.L. Clement and P.S. Jarrett. Antibacterial silver, Met Based Drugs. 1994; 1:467-482.
8. P. Dibrov, J. Dzioba, K.K. Gosink and C. Hase. Chemiosmotic mechanism of antimicrobial activity of Ag+ in Vibrio cholerae, Antimicrob Agents Chemother. 2002; 8:2668-2670.
9. CRC Handbook of Chemistry and Physics, 86th ed. Taylor & Francis; 2005-06:4.44-97.
10. Data on file at 3M.
11. ASTM E2315.03: Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure, Book of Standards: 11.05.
12. Data on file at 3M.
13. Data on file at 3M.
14. Bowler, P. G. MPhil; Jones, S. A. BSc; Walker, M. PhD; Parsons, D. PhD. Microbicidal Properties of a Silver-Containing Hydrofiber® Dressing Against a Variety of Burn Wound Pathogens, Jour of Burn Care and Rehabilitation. M/A 2004; 25(2):192-196.
15. Data on file at 3M.
16. Manual of Clinical Microbiology; 7th ed. ASM Press; 1999:1536-1539.
17. National Committee for Clinical Laboratory Standards; Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow
Aerobically; 1997.
18. International Standards Organization, ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and testing.
19. International Standards Organization, ISO 10993-5:1999: Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.
20. Data on file at 3M.
21. Data on file at 3M.
22. Worth AP, Cronin MT. The use of pH measurements to predict the potential of chemicals to cause acute dermal and ocular toxicity. Toxicology. 2001 Dec 14; 169(2):119-31.
23. Parsons, D. et al. Silver Antimicrobial Dressings in Wound Management: A Comparison of Antibacterial, Physical, and Chemical Characteristics. Wounds: A Compendium of Animal Research and Practice. 2005: 17(8); 222-232.
24. Data on file at 3M.
12
Delivering the
Power of Silver
Acticoat™ Burn Antimicrobial Dressing is a registered trademark of T.J. Smith & Nephew Corporation.
Aquacel® Ag Hydrofiber® Dressing with Silver is a registered trademark of ConvaTec Inc., a division of E.R. Squibb & Sons, L.L.C.
SilvaSorb® is a registered trademark of AcryMed Inc.
Silvercel® is a registered trademark of Systagenix Wound Management Ltd.
All other trade names referenced are the service marks, trademarks, or registered trademarks of their respective companies.
For more information, contact your 3M Skin & Wound Care Representative or call the 3M Health Care Customer Helpline
at 1 800 364-3577. These products can be ordered from your local distributor.
Skin & Wound Care Division
3M Canada Company
P.O. Box 5757
London, Ontario N6A 4T1
Canada
1 800-364-3577
www.3M.com/HealthCare
3M Health Care
3M Center Building 275-4W-02
St. Paul, MN 55144-1000
U.S.A.
Please recycle. Printed in Canada.
© 2011, 3M. All rights reserved.
3M, Cavilon, Coban and Tegaderm are trademarks of 3M.
Used under license in Canada.
1103-00809E