THE POWER SILVER · 2012-01-23 · 4 In vitroefficacy against virulent pathogens Tegaderm™ Ag...
Transcript of THE POWER SILVER · 2012-01-23 · 4 In vitroefficacy against virulent pathogens Tegaderm™ Ag...
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THE
POWEROFSILVER
A P R O D U C T M O N O G R A P H
3M™ Tegaderm™ Ag MeshDressing with Silver
3M Medicalfrom the 3M Health Care family
3M set out to create a dressing with the proven barrierprotection of antimicrobial ionic silver that is versatile, easyto use and affordable. We surveyed clinicians and identifiedthe following key performance criteria, which are detailed on the facing page.
Health care professionals around the globe already look to 3M for innovative solutions that reduce the risk ofinfection, provide better patient outcomes and reduce health care costs. Now they can look to us for a better choice in silver dressings, too.
Introducing 3M™ Tegaderm™ Ag Mesh Dressing with Silver.
EFFECTIVE VERSATILE EASY TO USE SAFE COST-EFFECTIVE
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Why use 3M™ Tegaderm™ Ag Mesh Dressing with Silver?
TegadermTM Ag Mesh dressing meets the key performance criteria identified by clinicians:
Effective*
Fast-acting microbial 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
Gauze-like material
Conformable
Can be cut, folded or fluffed
Safe
Meets ISO 10993 safety standards
Non-irritating
No to minimal skin or wound staining
Effective up to 7 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.
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Ionic silver works 3 ways to control bacteria
Clinical literature shows silver ions reduce microbial load through multiple mechanisms ofaction. This literature suggests that the risk of microorganisms becoming resistant to ionicsilver is minimized because of silver’s ability to destroy microbes in these ways:1
Tegaderm™ Ag Mesh dressing releasesionic silver rapidly and over time.*Particles of silver sulfate are coated on the surface of cotton fibers in theTegaderm™ Ag Mesh dressing. Whenwound exudate, sterile normal saline,sterile water or liquid hydrogel comes incontact with the dressing, the silversulfate dissolves, releasing silver ions inthe dressing rapidly and over time.
*Based on standard in vitromicrobiological methods.
The silver ions react withthe cell’s DNA, prohibitingreproduction.2
The silver ions bind to thecell wall, causing lysis.7, 8
The silver ions enter thecytoplasm and bind withenzymes that controlrespiration. The enzymes shutdown, suffocating the cell.2, 3, 4, 5, 6
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In vitro efficacy against virulent pathogens
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 ofpathogens 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 7 days. It inhibits the following strains of microbes:10
Aerobic
Acinetobacter sp.Aeromonas hydrophilaAlcaligenes sp.Bacillus cereusBacillus circulansBacillus licheniformisBacillus pumilusBacillus subtilisBurkholderia cepaciaCitrobacter amalonaticusCitrobacter diversusCitrobacter freundiiCitrobacter koseriCorynebacterium minutissimumEnterobacter aerogenesEnterobacter agglomeransEnterobacter cloacaeEnterococcus aviumEnterococcus durans
Enterococcus faecalisEnterococcus faeciumEnterococcus hiraeEnterococcus raffinosusEscherichia coliEscherichia vulnerisKlebsiella ornithinolyticaKlebsiella oxytocaKlebsiella pneumoniaeKlebsiella pneumoniae
subsp. ozaenaeListeria monocytogenesMoraxella (Branhamella) catarrhalisPasteurella aerogenesProteus mirabilisProteus hauseriProteus vulgarisProvidencia alcalifaciensProvidencia rettgeri
Providencia stuartiiPseudomonas aeruginosaPseudomonas alcaligenesPseudomonas fluorescensPseudomonas luteolaPseudomonas stutzeriSalmonella montevideoSalmonella typhimuriumSerratia marcescensStaphylococcus aureus Staphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus lugdunensisStaphylococcus saprophyticusStaphylococcus schleiferiStaphylococcus xylosusStreptococcus mitisStreptococcus pyogenes
Anaerobic
Bacteroides fragilisClostridium clostridioformeClostridium perfringensClostridium ramosumPeptostreptococcus anaerobiusTissierella praeacuta
Yeast and Fungi
Aspergillus fumigatusAspergillus nigerCandida albicansCandida glabrataCandida kruseiCandida tropicalisSaccharomyces cerevisiae
Antibiotic-Resistant(both aerobic and anaerobic)
Enterococcus faecalis (MDR)Enterococcus faecium (VRE)Staphylococcus aureus (MRSA)Staphylococcus epidermidis (MRSE) Stenotrophomonas maltophilia
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Fast-acting against the most challenging pathogens
Pathogens can multiply rapidly in a wound, so quick microbereduction is important to woundmanagement. Based on standardlaboratory time-kill assays,Tegaderm™ Ag Mesh dressingreduced the number ofpathogens—including common,drug-resistant bacteria—rapidlyover 2 hours.11 In statisticalcomparisons, the performance of Tegaderm™ Ag Mesh dressingat 120 minutes was comparableto that of the leading fast-actingsilver dressing, and exceeded the performance of several other silver dressings.12
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Acticoat™ Burn
SilvaSorb™
SilvaSorb®Gel
Silvercel®
Aquacel Ag
Tegaderm™ Ag
Methicillin Resistant Staphylococcus aureus
(MRSA)
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Acticoat™ Burn
SilvaSorb™
SilvaSorb®Gel
Silvercel®
Aquacel Ag
Tegaderm™ Ag
Vancomycin Resistant Enterococcus faecium
(VRE)
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Time (minutes)
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Acticoat™ Burn
SilvaSorb™
SilvaSorb®Gel
Silvercel®
Aquacel Ag
Tegaderm™ Ag
Pseudomonas aeruginosa
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Acticoat™ Burn
SilvaSorb™
SilvaSorb®Gel
Silvercel®
Aquacel Ag
Tegaderm™ Ag
Multidrug Resistant Enterococcus faecalis
(MDR)
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Acticoat™ Burn
SilvaSorb™
SilvaSorb®Gel
Silvercel®
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Tegaderm™ Ag
Methicillin Resistant Staphylococcus epidermidis
(MRSE)
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Acticoat™ Burn
SilvaSorb™
SilvaSorb®Gel
Silvercel®
Aquacel Ag
Tegaderm™ Ag
Candida albicans
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Long-term microbial suppression for added effectiveness
Long-term suppression of wound microbes minimizes pathogen regrowth and possible interference withwound healing.14 Based on an in vitro time-kill assay with longer exposure times, Tegaderm™ Ag Meshdressing demonstrated extended effectiveness with sustained microbial reduction over 14 days. Theperformance was comparable to that of a leading long-lasting silver dressing.13,14
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2 4 6 8 10 12 141 3 5 7 9 11 13
Methicillin Resistant Staphylococcus aureus
(MRSA)
Time (days)
Aquacel Ag
Tegaderm™ Ag
Mic
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(Lo
g10
CF
U)
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2 4 6 8 10 12 141 3 5 7 9 11 13
Vancomycin Resistant Enterococcus faecium
(VRE)
Time (days)
Mic
rob
ialL
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(Lo
g10
CF
U)
Aquacel Ag
Tegaderm™ Ag
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2 4 6 8 10 12 141 3 5 7 9 11 13
Pseudomonas aeruginosa
Time (days)
Mic
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Aquacel Ag
Tegaderm™ Ag0
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2 4 6 8 10 12 141 3 5 7 9 11 13
Bacteroides fragilis
Time (days)
Mic
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Aquacel Ag
Tegaderm™ Ag
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Efficacy in controlling varied wound flora
The following in vitro zone of inhibition studies15 demonstrate the effectiveness of Tegaderm™ Ag Meshdressing in controlling varying populations of bacteria—both from laboratory samples and from woundexudate isolates of patients with non-healing wounds.
In vitro assays with pure microbial cultures
In vitro study with wound exudate isolates
Tegaderm™ Ag Mesh Dressing
Agar
Zone of Inhibition
Staphylococcus epidermidis (MRSE)
Staphylococcus aureus (MRSA)
Pseudomonasaeruginosa
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 sampleis placed on the agar surface. As bacteria on the plate grow, they are inhibited to varying degrees, demonstratingthat the dressing can inhibit the growth of specific microbes.
ConclusionIn vitro studies show Tegaderm™ Ag Mesh dressing has the ability to inhibit growth of bacteria from patients’ wounds.
Aerobic Plate Anaerobic PlatePatient A A male patient presented with a 1 cm by 1 cm ulcer on the leftgreat toe that had been present for about 2 months. There waslittle drainage; no slough, tunneling or undermining.Predominant microorganisms inhibited were Staphylococcusaureus, a Gram-negative rod and a Gram-positive cocci.
Aerobic Plate Anaerobic Plate
Patient B A 52-year-old male presented with a 2.5 cm by 5 cm pressureulcer on the left heel that had been present for about 2 months.There was a moderate amount of purulent drainage, odor,erythema and slough, but no tunneling or undermining.Predominant microorganisms inhibited were two different Gram-negative rods, a Gram-positive cocci, Stenotrophomonasmaltophilia, Staphylococcus cohnii, Escherichia coli, Bacilluspumilus and Staphylococcus aureus.
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Meets ISO standardsTegaderm™ Ag Mesh meets ISO 10993 standards for the following:18
10993-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity10993-5: Tests for Cytotoxicity-In Vitro Methods19
10993-10: Tests for Irritation and Sensitization10993-11: Tests for Systemic Toxicity
A safe and effective form of silverWith Tegaderm™ Ag Mesh dressing, the surfaces of cotton fibers are coated with silver sulfate, one of themost soluble forms of ionic silver. When the dressing is moistened, safe and effective levels of ionic silverare quickly released, forming an effective barrier to reduce pathogens.20 Sulfate molecules naturally occur intissue components. Application of this dressing is not expected to significantly increase the existing level ofsulfates in a wound. There is no information to suggest that sulfite and sulfonamide (sulfa) allergic reactionsare 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 asignificant change in pH.21 When some silver dressings come in contact with saline, the pH of the salineshifts into a caustic alkaline range that may be damaging to healing cells and has been associated withchronic non-healing wounds.21, 22, 23
Non-staining to skin While skin staining is not clinically harmful in and of itself, discoloration may lead to inaccurateassessments. Some silver dressings result in substantial discoloration. Using conventional test methodology,Tegaderm™ Ag Mesh dressing resulted in significantly less skin discoloration.24
The safety you demand and expect from 3M
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Versatile and easy for clinicians to use
Useful for many wound typesTegaderm™ Ag Mesh nonwoven dressing is soft 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.
IndicationsTegaderm™ 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
Trochanter Lower Extremity
Heel Malleolus
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A 62-year-old female presented with a 27-month history of a lower extremity wound resulting from atraumatic laceration with subsequent cellulitis. Medical history was significant for obesity and SystemicLupus Erythematosus with long-term immunosuppressive therapy (corticosteroids and methotrexate). Thepatient 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 agentand non-contact normothermic therapy. Insurance issues necessitated several changes of health careproviders, leading to interruptions in wound care. While the wound bed was viable and wound edges open,the size had been unchanged for 7 months and there was an absence of healthy granulation tissue. Microbialimbalance was suspected as a factor in the wound’s failure to progress.
Tegaderm™ Ag Mesh dressing was applied with an expectation of controlling bioburden. The dressing waseasy to apply and versatile, allowing use with other dressing materials such as a compression wrap. It waswell tolerated by the patient without irritation, discomfort or evidence of staining. Tegaderm™ HydrogelWound Filler was used to moisten the dressing and maintain a moist wound bed. Complete healing occurredover 6 weeks with the Tegaderm™ Ag Mesh dressing helping to create an environment that promoted healing in a recalcitrant wound.
At admission 10/29/04 Tegaderm™ Ag Mesh dressing applied to wound
At 7 daysSignificant improvement noted.
Wound is smaller, granulation tissue evident.
At 6 weeksWound reepithelialized.
Patient case study: Visible wound improvement
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Compatible with many 3M products
From a name you can trust
Tegaderm™ Ag Mesh dressing can be safely used with the following skin and wound care products:
3M™ Tegaderm™ HI & HG Alginate Dressings 3M™ Tegaderm™ Hydrogel Wound Filler3M™ Tegaderm™ + Pad Film Dressing
with Non-Adherent Pad3M™ Tegaderm™ Foam Dressings
3M™ Coban™ Self-Adherent Wrap3M™ Coban™ 2 Layer Compression System3M™ Cavilon™ No Sting Barrier Film3M™ Wound Cleanser
Since inventing incise antimicrobial surgical drapes more than 30 years ago, 3M has been a worldwideleader in developing health care products and services for both providers and consumers. Our health careinnovations span 3M core technologies:
Infection PreventionAttest™ Biological Indicators and IncubatorsAvagard™ Hand Antiseptic with MoisturizersComply™ Sterilization IndicatorsDuraPrep™ Surgical Solution
Face and Surgical MasksIoban™ 2 Antimicrobial Incise DrapesOne-Step Patient PrepSteri-Drape™ Incise DrapesSurgical Clippers
Medical Data ManagementClaim Scrubber SoftwareCodefinder™ SoftwareMedical Necessity SoftwareReimbursement Calculation Software
Porous Materials and MembranesNexcare™ GauzeSteri-Drape™ Surgical Drapes
Pressure-Sensitive and Specialty AdhesivesSteri-Drape™ Surgical DrapesSteri-Strip™ Skin ClosuresSteri-Strip™ S Surgical ClosureTegaderm™ Dressings
NonwovensMicropore™ Surgical TapeNexcare™ Consumer First Aid Products
FilmsHeat-Sealable Polyester Medical Packaging Film Incise Film Tape used in surgical drapes
With every innovation—including3M™ Tegaderm™ Ag Mesh Dressingwith Silver—our health care partners know they can rely on our solid foundation of easy-to-use, high-quality and effective products.
All products listed are trademarks of 3M.
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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 AgentsChemother. 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® DressingAgainst 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.
Acticoat™ Burn Antimicrobial Dressing is a trademark of Smith & Nephew.
Aquacel® Ag Hydrofiber Dressing with Silver is a registered trademark of E.R. Squibb & Sons, L.L.C.
SilvaSorb™ is a trademark of AcryMed, Inc.
Silvercel® is a registered trademark of Johnson & Johnson Corporation.
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For more information, visit our website at www.3M.com/skinhealth, contact your 3M Health Care Representative or call the 3M Health Care Customer Helpline at 1-800-228-3957. These products can be ordered from your local distributor.Outside the United States contact the local 3M subsidiary.