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
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