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Gore Antimicrobial Technology and Medical Device Infections.

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Presentation on theme: "Gore Antimicrobial Technology and Medical Device Infections."— Presentation transcript:

1 Gore Antimicrobial Technology and Medical Device Infections

2 Outline Infections and Medical Devices –Incidence and Impact –Role of Biofilms Gores Antimicrobial Technology –What is It? –How Does it Work? –Safety and Efficacy

3 Infections and Medical Devices

4 Hospital-Acquired Infections United States Nearly 2 million nosocomial infections per year 1,2 –~90,000 deaths –>70% of the causal bacteria are resistant Patients with drug-resistant infections 1 –Longer hospital stays –Treatment with drugs that may be less effective, more toxic, and/or more expensive Nearly $11 billion annually 2 1.Campaign to prevent antimicrobial resistance in healthcare settings. Centers for Disease Control and Prevention web site. Available at Accessed September 12, Schierholz JM, Beuth J. Implant infections: a haven for opportunistic bacteria. Journal of Hospital Infection 2001;49:87-93.

5 Surgical Site Infections United States ~700,000 surgical site infections per year 1 ~$1.6 billion added hospital charges annually 2 One study 2 : Outcome Control (n=193) MSSA (n=165) MRSA (n=121) Death (number)41125 Hospital stay (days)51423 Cost (median)$29,455$52,791$92,363 1.Nathens AB, Dellinger EP. Surgical site infections. Current Treatment Options in Infectious Diseases 2000;2: Engemann JJ, Carmeli Y, Cosgrove SE, et al. Adverse clinical and economic outcomes attributable to methicillin resistance among patients with Staphylococcus aureus surgical site infection. Clinical Infectious Diseases 2003;36: MRSA = methicillin-resistant S. aureus; MSSA = methicillin-susceptible S. aureus

6 MRSA Prevalence 1,2 –Precipitous rise –43% of hospital S. aureus infections –28% of surgical site infections Problems 1,2 –Generally multi-drug resistant –MRSA only susceptible to vancomycin grew from 23% to 56% in 10 years –Resistance to vancomycin has emerged 1.Kuehnert MJ, Hill HA, Kupronis BA, Tokars JI, Solomon SL, Jernigan DB. Methicillin-resistant–Staphylococcus aureus hospitalizations, United States. Emerging Infectious Diseases [serial online] 2005;11(6). Available at: Accessed September 12, Fry DE. Complicated skin and skin structure infections caused by hospital- and community-acquired MRSA: What surgeons need to know [CME course on the Internet]. Available at: disclaimer_html.display?ip_mode =secure&ip_company_code=CMEZPHY&ip_test_id=8297&ip_cookie= Accessed August 19, 2005.

7 Medical Device Infections 1-6% of implanted medical devices become infected 1 –Account for ~45% of nosocomial infections 2 Ventral Hernia Repair 3 –Open 7-18% –Laparoscopic 0-2% Timeframe –Short term – within first 10 days –Long term – up to several years post op 1.Gristina AG, Naylor P, Myrvik Q. Infections form biomaterials and implants: a race for the surface. Medical Progress Through Technology 1998;4: Stamm WE. Infections related to medical devices. Annals of Internal Medicine 1978;89: Carbonell AM, Matthews BD, Dreau D, et al. The susceptibility of prosthetic biomaterials to infection. Surgical Endoscopy 2005;19:

8 Consequences of Device Infections Increased –Pain and discomfort –Hospital stay –Healing/recovery time –Cost –Morbidity –Mortality May require additional surgery to remove device Infected polypropylene mesh seven months post operatively.

9 Pathogenesis of Infection A Race for the Surface 1,2 Bacteria introduced primarily at time of implant or in the immediate post-op period –Patients own skin flora –Pre-existing infection at distant site –Hospital environment –Surgical staff –Supporting therapy (IV, etc.) Bacteria adhere to and colonize device –Bacteria can produce their own protective biofilm –Bacteria evade conventional antibiotic therapy and patients immune response 1.Gristina AG, Naylor P, Myrvik Q. Infections from biomaterials and implants: a race for the surface. Medical Progress Through Technology 1998;4: Deysine M. Pathophysiology, prevention, and management of prosthetic infections in hernia surgery. Surgical Clinics of North America 1998;78(6):

10 I just cant go with the flow anymore. Ive been thinking about joining a biofilm. Bacteria Want to Be in Biofilms Center for Biofilm Engineering, Montana State University

11 Biofilms

12 What Are Biofilms and Why Are They Important? Biofilm –Bacteria in a self-excreted slimy substance adhered to a surface 1 Bacteria in biofilms 2 –No longer planktonic –Act as a community –Often multiple species Estimated 65% of human infections involve biofilms 3 –Provide protection from hosts immune response –Can require 1000x antibiotic concentration to kill versus planktonic 2 1.Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science 1999;284: What being in a biofilm means to bacteria. The Center for Biofilm Engineering at Montana State University Web Site. Available at: Accessed September 26, Cvitkovitch DG, Li Y-H, Ellen RP. Quorum sensing and biofilm formation in Streptococcal infections. Journal of Clinical Investigation 2003;112:

13 Necrotic Cellular DebrisBacteria Within Debris Biofilms Can Be Difficult to Detect Culture –Short culture times may lead to false negatives Histology –Bacteria can be hidden in biofilm

14 Biofilm Formation Center for Biofilm Engineering, Montana State University

15 Biofilm Formation Center for Biofilm Engineering, Montana State University

16 Plaque is a Biofilm

17 Biofilm on ePTFE RBC Bacteria (cocci) Biofilm (slime) Bruce Wagner, W.L. Gore & Associates, Inc. ePTFE

18 Olson ME, Ruseka I, Costerton JW. Colonization of n-butyl-2-cyanoacrylate tissue adhesive by Staphylococcus epidermidis. Journal of Biomedical Materials Research 1988;22: hours 4 hours 24 hours Biofilm Formation 8 hours

19 Betsey Pitts, Center for Biofilm Engineering, Montana State University 3-D Imaging of Biofilm

20 Clinical Impact of Biofilms Two main infection scenarios –Short term – within 10 days –Long term – up to several years post op Treatment progression –Broad spectrum and/or specific antibiotics –Wound does not heal and is culture negative –Device is removed

21 The Challenge Protect the device from colonization at time of implant.

22 Gores Solution Device coating as first line of defense against bacterial colonization –Resist bacterial adherence –Effective against a broad spectrum of bacteria Local rather than systemic exposure –Small amounts of agents –Protect device, not treat surrounding tissue Agents not typically used to treat infections –Does not affect choice of local or systemic antibiotics –Minimal tendency toward resistance

23 Gores Antimicrobial Technology

24 What is it? –Synergistic combination of two antimicrobial agents, silver and chlorhexidine Silver –Binds with and destroys bacterial cell proteins, causing loss of normal biological function Chlorhexidine –Permeates bacterial cell wall causing disruption and leakage of the cell contents

25 What Does Antimicrobial Technology Do? Inhibits bacterial colonization of, and resists initial biofilm formation on, the device for up to 14 days post implantation.

26 Safety and Efficacy of Antimicrobial Technology

27 Safety of Gores Antimicrobial Technology Clinical Experience Short-term study 1 –37 patients; controlled, randomized –PLUS products do not appear to produce any adverse systemic or clinical effects after hernia repair Almost 10 years and over 150,000 implants –To date no confirmed reports of hypersensitivity 1.DeBord JR, Bauer JJ, Grischkan DM, LeBlanc KA, Smoot Jr. RT, Voeller GR, Weiland LH. Short-term study on the safety of antimicrobial-agent- impregnated ePTFE patches for hernia repair. Hernia 1999;3:

28 In-Vitro Efficacy of Gores Antimicrobial Technology Zone of inhibition bioassays Substantial antimicrobial activity against gram-positive and gram-negative organisms –Staphylococcus aureus –Escherichia coli –Pseudomonas aeruginosa –Klebsiella pneumoniae –Staphylococcus epidermidis –Candida albicans –Methicillin-resistant Staphylococcus aureus (MRSA) –Vancomycin-resitant enterococcus faecalis –Group A Streptococcus –Acinetobacter baummanii

29 In-Vivo Efficacy of Gores Antimicrobial Technology Rabbit model 10 days post-inoculation with S. aureus Non-antimicrobial Technology Antimicrobial Technology Colonization of the implant surface and interstices. (H&E stain; 20x magnification) Protection of the implant surface and interstices from colonization. (H&E stain; 20x magnification)

30 Susceptibility to MRSA Adherence AG Harrell, American Hernia Society Meeting, Feb –Compared MRSA adherence to various types of meshes using an in-vitro model Methods –Inoculated with 10 8 MRSA in tryptic soy broth –Incubated for 1 hour at 37 o C –Washed and counted CFU in wash and broth –SEM of meshes Products tested –GORE DUALMESH ® PLUS Biomaterial –GORE DUALMESH ® Biomaterial –Bard ® Mesh –Bard ® COMPOSIX ® E/X Mesh –PROCEED Surgical Mesh –PARIETEX ® COMPOSITE Mesh –TiMESH Mesh-Implant –ULTRAPRO Mesh –VYPRO Mesh Harrell AG. Prosthetic mesh biomaterial susceptibility to methicillin resistant Staphylococcus aureus adherence in an in-vitro model. Abstract presented at Hernia Repair American Hernia Society. San Diego, CA. Feb 9-12, Page 94. Abstract 36F.

31 Results of MRSA Adherence GORE DUALMESH ® PLUS Biomaterial Harrell AG. Prosthetic mesh biomaterial susceptibility to methicillin resistant Staphylococcus aureus adherence in an in-vitro model. Abstract presented at Hernia Repair American Hernia Society. San Diego, CA. Feb 9-12, Page 94. Abstract 36F.

32 Susceptibility to MRSA Adherence GORE DUALMESH ® PLUS Biomaterial –No detectable MRSA in the broth or the pooled wash samples –SEM confirmed bacterial adherence to all other mesh types –Only mesh type in the nine tested that demonstrated a bactericidal property Harrell AG. Prosthetic mesh biomaterial susceptibility to methicillin resistant Staphylococcus aureus adherence in an in-vitro model. Abstract presented at Hernia Repair American Hernia Society. San Diego, CA. Feb 9-12, Page 94. Abstract 36F.

33 Mesh Susceptibility to Infection AM Carbonell et al, Surg Endosc 2005 –Determine the susceptibility of mesh to S. aureus infection in a rat model Methods –Created 2 cm 2 hernia defect and sutured mesh to it –Inoculated each mesh with 10 8 penicillin-sensitive S. aureus –5 day incubation –Harvested biomaterials sterilely, washed, cultured, counted CFU Meshes tested –GORE DUALMESH ® PLUS Biomaterial –GORE DUALMESH ® Biomaterial –Bard ® Mesh –Bard ® COMPOSIX ® Mesh –SEPRAMESH Biosurgical Composite –SURGISIS ® Soft Tissue Graft –ALLODERM ® Regenerative Tissue Matrix Carbonell AM, Matthews BD, Dreau D, et al. The susceptibility of prosthetic biomaterials to infection. Surgical Endoscopy 2005;19:

34 Mesh Susceptibility to Infection Carbonell AM, Matthews BD, Dreau D, et al. The susceptibility of prosthetic biomaterials to infection. Surgical Endoscopy 2005;19: Significant Values: 1) DM+ < DM, M, X, SM, S, A, P (p=0.05). 2) SM < A (p=0.05). 3) P < A (p=0.05) Log 10 Values for Wash Count GORE DUALMESH ® PLUS Biomaterial

35 Mesh Susceptibility to Infection Carbonell AM, Matthews BD, Dreau D, et al. The susceptibility of prosthetic biomaterials to infection. Surgical Endoscopy 2005;19: Log 10 Values for Broth Count Significant Values: 1) DM+ < DM, M, X, SM, S, A, and P (p=0.05). 2) P < DM, M, X, SM, S, and A (p=0.05). GORE DUALMESH ® PLUS Biomaterial

36 Mesh Susceptibility to Infection GORE DUALMESH ® PLUS Biomaterial –Was the least susceptible to infection –Able to kill all the inoculated bacteria in a live-animal study of mesh infection Silver/chlorhexidine meshes –May be the prosthetics of choice to minimize occurrence of mesh infection Carbonell AM, Matthews BD, Dreau D, et al. The susceptibility of prosthetic biomaterials to infection. Surgical Endoscopy 2005;19:

37 Clinical Experience with Gores Antimicrobial Technology Laparoscopic Ventral Hernia Repair KA LeBlanc, MD, MBA, FACS 1 –The use of GORE DUALMESH ® PLUS Biomaterial appears to anecdotally decrease the rate of infections. We have not encountered a postoperative infection when this prosthesis was used. AM Carbonell et al. 2 –268 laparoscopic ventral hernia repairs using ePTFE –Two mesh infections, neither of which occurred with GORE DUALMESH ® PLUS Biomaterial 1.LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications–how to avoid and handle. Hernia 2004;8(4): Carbonell AM, Matthews BD, Dreau D, et al. The susceptibility of prosthetic biomaterials to infection. Surgical Endoscopy 2005;19:

38 Summary Medical Device Infections –Increase morbidity, mortality, cost, etc. –Biofilm formation makes diagnosis and treatment difficult –The best treatment is prevention Gores Antimicrobial Technology –Inhibits bacterial colonization for up to 14 days post implantation –Currently available in devices used for soft tissue repair

39 Considerations Do NOT alter usual practice of pre-, peri-, or post-operative administration of local or systemic antibiotics NOT recommended for contaminated fields NOT for treatment of infection NOT for patients with hypersensitivity to chlorhexidine or silver NOT for pre-term and neonatal populations Product(s) listed may not be available in all markets pending regulatory clearance. GORE, DUALMESH ®, DUALMESH ® PLUS, and designs are trademarks of W. L. Gore & Associates. ALLODERM ® is a trademark of LifeCell Corporation. BARD ®, MARLEX ®, and COMPOSIX ® are trademarks of C. R. Bard, Inc. PARIETEX ® is a trademark of Sofradim Production, Inc. PROCEED ®, ULTRAPRO ®, and VYPRO are trademarks of Ethicon, Inc. SEPRAMESH ® is a trademark of Genzyme Corporation. SURGISIS ® is a trademark of Cook Biotech, Inc. TIMESH ® is a trademark of Medtronic, Inc. © 2007 W. L. Gore & Associates, Inc. AJ1857-EN3 MAY 2007 W. L. Gore & Associates, Inc. Flagstaff, AZ goremedical.com CONTRAINDICATIONS: Patients with hypersensitivity to chlorhexidine or silver; reconstruction of cardiovascular defects; reconstruction of central nervous system or peripheral nervous system defects; pre-term and neonatal populations. WARNINGS: Use with caution in patients with methemoglobinopathy or related disorders. When used as a temporary external bridging device, use measures to avoid contamination; the entire device should be removed as early as clinically feasible, not to exceed 45 days after placement. When unintentional exposure occurs, treat to avoid contamination or device removal may be necessary. Improper positioning of the smooth non-textured surface adjacent to fascial or subcutaneous tissue will result in minimal tissue attachment. POSSIBLE ADVERSE REACTIONS: Contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma and recurrence.


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