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Index ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. ® Ciba Corporation Inc *Trademark © ETHICON, INC. 2008 All Rights Reserved
What Are SSIs? ,[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Nichols RL.  Emerg Infect Dis.  2001;7:220-224.  World Health Organization. 2002;1-50. © ETHICON, INC. 2008 All Rights Reserved
SSI-causing Pathogens and Frequencies 0% 5% 10% 15% 20% 25% S taphylococcus aureus CNS Enterococci Escherichia   coli Pseudomonas aeruginosa Enterobacter spp Infections (%) Gram positive Gram negative Confidential. For Internal Use Only. CNS=coagulase-negative  Staphylococcus . National Nosocomial Infections Surveillance System. www.cdc.gov. Mangram AJ et al.  Am J Infect Control.  1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
CDC Surgical Wound Categories Confidential. For Internal Use Only. CDC=Centers for Disease Control and Prevention. Mangram AJ et al.  Am J Infect Control.  1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved  Class I/Clean Uninfected wound in which no inflammation is encountered and respiratory, alimentary, genital, or uninfected urinary tract is not entered.  Class II/Clean-contaminated Operative wound in which respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination.  Class III/Contaminated Open, fresh, accidental wounds.  Class IV/  Dirty-infected Old traumatic wounds with retained devitalized tissue  and those that involve existing clinical infection or perforated viscera.
Factors in Bacterial Colonization  Leading to SSIs ,[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Hebert CK et al.  Clin Orthop .  1996;331:140-145. Fletcher N et al.  J Bone Joint Surg Am . 2007;89:1605-1618. Mangram AJ et al.  Am J Infect Control . 1999;27:97-134. Fry DE.  Medscape Surgery . 2003. © ETHICON, INC. 2008 All Rights Reserved
SSI Risk Factors – Patient Related ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Sumnicht RW.  Med Bull US Army Eur.  1958;15:51-56. Mangram AJ et al.  Am J Infect Control.  1999;27:97-134.  Fry DE.  Medscape Surgery.  2003. © ETHICON, INC. 2008 All Rights Reserved
SSI Risk Factors – Procedures/Techniques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Mangram AJ et al.  Am J Infect Control.  1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
SSI Risk Factors – Procedures/Techniques Cont’d ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Nguyen D et al.  Infect Cont Hosp Epidemiol.  2001;22:485-492. Mangram AJ et al.  Am J Infect Control.  1999;27:97-134.  Fry DE.  Medscape Surgery.  2003. © ETHICON, INC. 2008 All Rights Reserved
SSI Postoperative Issues ,[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Mangram AJ et al.  Am   J Infect Control.  1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
Objective: Control Microbiologic Risk Personnel Patient Factors Surgical Site Tools Operating Room Confidential. For Internal Use Only. © ETHICON, INC. 2008 All Rights Reserved
Independent Factors  Associated With Increased SSI Risk ,[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Mangram AJ et al.  Am J Infect Control . 1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
SSI Rates in Various Surgical Procedures ,[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. CABG=coronary artery bypass graft. Gabriel SE et al.  N Engl J Med.  1997;336:677-682. Hollenbeak CS et al.  Chest . 2000;118:397-402. Gaynes RP et al.  Clin Infect Dis . 2001;33(suppl 2):S69-S77. © ETHICON, INC. 2008 All Rights Reserved
Additional Factors Affecting SSI Rates ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Dose of Bacterial Contamination    Virulence Resistance of the Host Patient Risk of SSI = Confidential. For Internal Use Only. Mangram AJ et al.  Am   J Infect Control.  1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
The Risks of Biofilm ,[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Donlan RM.  Emerg Infect   Dis . 2001;7:277-281. Edmiston CE et al.  J Am Coll Surg.  2006;203:481-489. Mangram AJ et al.  Am   J Infect Control.  1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
Consequences & Costs Associated With SSIs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Bratzler DW et al.  Am J Surg.  2005;189:395-404. Bratzler DW et al.  Clin Infect Dis.  2006;43:322-330. Urban JA.  Surg Infect (Larchmt).  2006;7(suppl 1):S19-S22. Kovach TL.  Infect Cont Today . June 1, 2005. © ETHICON, INC. 2008 All Rights Reserved
Additional Costs Associated With SSIs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Urban JA.  Surg Infect (Larchmt).  2006;7(suppl 1):S19-S22. © ETHICON, INC. 2008 All Rights Reserved
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Nichols RL.  Emerg Infect Dis.  2001;7:220-224. © ETHICON, INC. 2008 All Rights Reserved
IRGACARE ®  MP (triclosan) Properties ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. USP=United States Pharmacopeia. Zurita R et al.  Macromol Biosci.  2006;6:58-69. Ming X et al.  Surg Infect (Larchmt).  2007;8:201-207. Ming X et al.  Surg Infect (Larchmt).  2008;9:451-457. Barbolt TA.  Surg Infect (Larchmt).  2002;3(suppl 1):S45-S53. ® Ciba Corporation Inc © ETHICON, INC. 2008 All Rights Reserved
IRGACARE ®  MP (triclosan): Mode of Action ,[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Zurita R et al.  Macromol Biosci.  2006;6:58-69. ® Ciba Corporation Inc © ETHICON, INC. 2008 All Rights Reserved
Why IRGACARE ®  MP (triclosan)? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Storch M et al.  Surg Infect (Larchmt).  2002;3(suppl 1):S65-S77. ® Ciba Corporation Inc © ETHICON, INC. 2008 All Rights Reserved
IRGACARE ®  MP (triclosan): Pharmacokinetics ,[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Barbolt TA.  Surg Infect (Larchmt).  2002;3(suppl 1):S45-S53. ® Ciba Corporation Inc © ETHICON, INC. 2008 All Rights Reserved
IRGACARE ®  MP (triclosan) and Microbial Resistance ,[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Ming X et al.  Surg Infect (Larchmt).  2007;8:209-213. Barbolt TA.  Surg Infect (Larchmt).  2002;3(suppl 1):S45-S53. Ford HR et al.  Surg Infect   (Larchmt).  2005;6:313-321. ® Ciba Corporation Inc © ETHICON, INC. 2008 All Rights Reserved
Triclosan-Coated Sutures for the Reduction of Sternal Wound Infections: Economic Considerations ,[object Object],Confidential. For Internal Use Only. © ETHICON, INC. 2008 All Rights Reserved
Results ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Fleck T et al.  Ann Thorac Surg . 2007;84:232-236. *Trademark © ETHICON, INC. 2008 All Rights Reserved
Antimicrobial Suture Wound Closure for Cerebrospinal Fluid Shunt Surgery: a Prospective, Double-blinded, Randomized Controlled Trial Rozzelle CJ, Leonardo J, Li V.  J Neurosurg Pediatrics.  2008;2:111-117. Confidential. For Internal Use Only. © ETHICON, INC. 2008 All Rights Reserved
Results and Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Confidential. For Internal Use Only. Rozzelle CJ et al.  J Neurosurg Pediatrics . 2008;2:111-117. © ETHICON, INC. 2008 All Rights Reserved
[object Object],[object Object]
Results and Conclusions ,[object Object],[object Object],[object Object],[object Object]

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Toronto ethicon lecture jan 2010

  • 1.
  • 2.
  • 3. SSI-causing Pathogens and Frequencies 0% 5% 10% 15% 20% 25% S taphylococcus aureus CNS Enterococci Escherichia coli Pseudomonas aeruginosa Enterobacter spp Infections (%) Gram positive Gram negative Confidential. For Internal Use Only. CNS=coagulase-negative Staphylococcus . National Nosocomial Infections Surveillance System. www.cdc.gov. Mangram AJ et al. Am J Infect Control. 1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved
  • 4. CDC Surgical Wound Categories Confidential. For Internal Use Only. CDC=Centers for Disease Control and Prevention. Mangram AJ et al. Am J Infect Control. 1999;27:97-134. © ETHICON, INC. 2008 All Rights Reserved Class I/Clean Uninfected wound in which no inflammation is encountered and respiratory, alimentary, genital, or uninfected urinary tract is not entered. Class II/Clean-contaminated Operative wound in which respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Class III/Contaminated Open, fresh, accidental wounds. Class IV/ Dirty-infected Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10. Objective: Control Microbiologic Risk Personnel Patient Factors Surgical Site Tools Operating Room Confidential. For Internal Use Only. © ETHICON, INC. 2008 All Rights Reserved
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25. Antimicrobial Suture Wound Closure for Cerebrospinal Fluid Shunt Surgery: a Prospective, Double-blinded, Randomized Controlled Trial Rozzelle CJ, Leonardo J, Li V. J Neurosurg Pediatrics. 2008;2:111-117. Confidential. For Internal Use Only. © ETHICON, INC. 2008 All Rights Reserved
  • 26.
  • 27.
  • 28.

Hinweis der Redaktion

  1. Note: Topics to be covered in this deck: Surgical Site Infections (SSIs) Plus SUTURES, including IRGACARE ® MP (triclosan) Integrity Selling Strategy Summary and Key Follow-ups
  2. Note: This is a reminder of the common pathogens implicated in surgical site infections, or SSIs Gram-positive organisms are the most common pathogens, specifically staphylococci ( Staphylococcus aureus and coagulase-negative Staphylococcu s [CNS]), and enterococci. Keep in mind that the incidence of methicillin-resistant Staphylococcus aureus (MRSA) is on the rise Gram-negatives, another type of bacteria, include Escherichia coli , and Pseudomonas and Enterobacter species. The incidence of gram-negative resistance is also on the rise
  3. Note: The Centers for Disease Control and Prevention, or CDC, classifies surgical wounds into 4 categories: Class I/Clean Class II/Clean-contaminated Class III/Contaminated Class IV/Dirty-infected
  4. Note: There are a number of factors that contribute to bacterial colonization that can lead to surgical site infections
  5. Note: These SSI risk factors are patient related
  6. Note: These are surgical factors that contribute to SSI risk
  7. Note: During surgery, these factors can contribute to SSI risk
  8. Note: Because SSIs can occur days after surgery, certain postoperative issues are important to consider Discuss targeting the ICU or PA/Residents to determine who changes dressings. A lot of times the resident changes the dressings in the ICU and do not change gloves, which can lead to cross-examination
  9. Note: Many factors play a role in the wound closure environment: the operating room, tools used to close the wound, personnel using aseptic technique, and patient factors (eg, other disease states, the extent of the surgical procedure, and level of immune system function)
  10. Note: There are some additional factors that affect SSI risk
  11. Note: SSIs are a major source of postoperative complications and can result in increased mortality for patients
  12. Note: One factor increasing this trend is the prevalence of patients with comorbidities These patient populations include patients who are immunocompromised (HIV, organ transplants), elderly, in renal failure, or have diabetes, as well as other patient populations
  13. Note: When microorganisms like bacteria attach themselves to the surface of an implanted medical device like a suture, they form biofilms that make themselves highly resistant to antimicrobial treatment and extremely difficult to remove from the surface of the device
  14. Note: SSIs are a deviation from the optimal or “standard” postoperative course When calculating costs related to SSIs, it is important to take into account both direct and indirect costs
  15. Note: Direct and indirect costs of SSIs include decreased patient satisfaction and increased litigation
  16. Note: Sum up the serious and growing problem
  17. Note: IRGACARE ® MP (triclosan) is a biocidal agent used in all Plus SUTURES products IRGACARE MP is a high-purity material that meets United States Pharmacopeia specifications for triclosan and contributes minimally to the background exposure to toxic residues It has demonstrated antibacterial efficacy and a long history of safety. IRGACARE MP is active against the most common pathogens implicated in SSIs, including S aureus , S epidermidis , and others IRGACARE MP is also a great candidate for incorporation into sutures because of its compatibility with suture processing
  18. Note: The mode of action of triclosan is widely unknown The triclosan used in Plus SUTURES is the highly purified form, IRGACARE ® MP Recent studies have shown that it acts as a competitive inhibitor of an essential enzyme in fatty acid synthesis: enoyl-acyl carrier protein reductase
  19. Note: IRGACARE ® MP (triclosan) withstands manufacturing processes, is cost-effective, and has excellent physical and functional properties Coated polyglactin 910 sutures with triclosan appeared to exhibit no difference from traditional polyglactin 910 sutures with respect to tactile smoothness, dry tie-down, and wet tie-down
  20. Note: IRGACARE ® MP (triclosan) has favorable pharmacokinetic properties. It is well absorbed (50% – 100%) by the gastrointestinal tract and well distributed in the body It binds to serum albumin and is present as the sulfate and/or glucuronide conjugate, depending on exposure There is no indication that triclosan accumulates in plasma over time, nor is it stored after single or repeated exposure
  21. Note: IRGACARE ® MP (triclosan) has favorable pharmacokinetic properties. It is well absorbed (50% – 100%) by the gastrointestinal tract and well distributed in the body It binds to serum albumin and is present as the sulfate and/or glucuronide conjugate, depending on exposure There is no indication that triclosan accumulates in plasma over time, nor is it stored after single or repeated exposure
  22. Note: These results support the suggestion that the use of antimicrobial sutures for cerebrospinal fluid shunt surgery wound closure is safe, effective, and may be associated with a reduced risk of postoperative shunt infection