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Index
• Understanding SSIs• Causes
• Risk factors
• Cost and consequences
IRGACARE® MP (triclosan)
Clinical study review
1Confidential. For Internal Use Only.
® Ciba Corporation Inc
*Trademark
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What Are SSIs?
•SSIs are infections associated with surgical procedures and are a major source of postoperative illness
•These infections are responsible for approximately one quarter of all nosocomial infections and affect 1.4 million people worldwide at any time
•SSIs result in longer hospitalization, increased patient mortality and higher costs for healthcare providers and payers
2Confidential. For Internal Use Only.
Nichols RL. Emerg Infect Dis. 2001;7:220-224.
World Health Organization. 2002;1-50.
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SSI-causing Pathogens and Frequencies
0%
5%
10%
15%
20%
25%
Staphylococcusaureus
CNS Enterococci Escherichia coli
Pseudomonasaeruginosa
Enterobacterspp
Infe
ctio
ns (
%) Gram positive
Gram negative
3Confidential. 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.
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CDC Surgical Wound Categories
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.
4Confidential. For Internal Use Only.
CDC=Centers for Disease Control and Prevention.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
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Factors in Bacterial Colonization Leading to SSIs
•Patient-related•Procedure/Techniques•Postoperative• Implants
5Confidential. 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.
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SSI Risk Factors – Patient Related
• Advanced age
• Malnutrition
• Obesity
• Diabetes mellitus
• History of smoking
• Distant infection
• Steroid therapy
• Chronic inflammation
• Open wounds
• Radiation
• Immunosuppressed
• Length of preoperative stay
6Confidential. 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.
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SSI Risk Factors – Procedures/Techniques
• Duration of operation• Duration of surgical scrub• Preoperative shaving,
skin preparation• Inadequate OR ventilation• Inadequate sterilization of
instruments• Surgical technique
• Poor hemostasis• Failure to obliterate dead
space• Tissue trauma• Skin antisepsis• Antimicrobial prophylaxis• Surgical drains
7Confidential. For Internal Use Only.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
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SSI Risk Factors – Procedures/Techniques Cont’d•Length of preoperative hospital stay• Insufficient preoperative preparation•Personal hygiene, hair removal, skin disinfection• Insufficient antibiotic therapy• Intraoperative hypothermia• Intraoperative hypoxemia• Intraoperative hypotension
8Confidential. 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.
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SSI Postoperative Issues
• Incision care•Sterile dressing•Dressing changes (use of sterile technique, aseptic precautions)
•Discharge planning•Home incision care
9Confidential. For Internal Use Only.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.
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Objective: Control Microbiologic Risk
Personnel
Patient Factors
Surgical SiteSurgical Site
Too
lsO
perating R
oom
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Independent Factors Associated With Increased SSI Risk
•Abdominal operation•Operation lasting >2 hours•Surgical site with wound classification of either contaminated or dirty-infected•All wounds are contaminated; the level of contamination determines the severity or presence of an infection
•Operation performed on patient having ≥3 discharge diagnoses
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Mangram AJ et al. Am J Infect Control. 1999;27:97-134.© ETHICON, INC. 2008 All Rights Reserved
© ETHICON, INC. 2007
SSI Rates in Various Surgical Procedures
•Plastic (breast implantations 1964–1991); N=749 women; 2.5%
•Cardiovascular (CABG 1996–1998); N=1,519 procedures; 2.7%
•Orthopedic (1992–1993); N=11,309 hospitalized orthopedic patients; 1.1%– 2.2%
•Gastric (1992–1998); N=1,184 moderate to high-risk procedures; 11%
12Confidential. 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.
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Additional Factors Affecting SSI Rates
• Growing problems
-Emergence of resistant organisms
-More debilitated, elderly, immunocompromised patients; comorbid disease
-Organ transplants
-Prosthetic implants
• The risk of SSI can be generally defined as the amount of bacterial contamination at the site of the infection combined with the virulence, or degree of pathogenicity, of the bacteria in relation to the immune system resistance of the patient
Dose of Bacterial Contamination Virulence
Resistance of the Host Patient
Risk of SSI=
13Confidential. For Internal Use Only.
Mangram AJ et al. Am J Infect Control. 1999;27:97-134.© ETHICON, INC. 2008 All Rights Reserved
© ETHICON, INC. 2007
The Risks of Biofilm
• Biofilm is created when microorganisms like bacteria attach themselves to living or nonliving surfaces in internal or external environments
• For instance, postoperative bacteria may contaminate the tissue in a surgical wound as well as the suture material itself
• Furthermore, the bacteria develop extracellular polymers that promote greater adhesion and resistance to antimicrobial treatment
14Confidential. 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
© ETHICON, INC. 2007
Consequences & Costs Associated With SSIs
• Increased length of hospital stay (7–10 days), cost, and mortality (doubled)
• 60% more likely to spend time in the intensive care unit
• 5 times more likely to be readmitted to the hospital
• Cost ranges from $400 for superficial incisional SSI to >$30,000 for sternal wound or other serious infection
• Indirect costs (patient, family) are rarely considered• Loss of productivity, functional capacity
• Nearly 90,000 people die annually from healthcare-acquired infections (HAIs). SSIs are the most common HAI among surgical patients
• More people die from HAIs than AIDS, motor vehicle accidents, and breast cancer combined
15Confidential. 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.
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Additional Costs Associated With SSIs
• Indirect costs• Lost productivity (patient, family)• Temporary or permanent impairment of physical/mental function
• Decreased patient satisfaction• Decreased referrals• Increased litigation
• Direct costs• Prolonged hospitalization, readmission
• Outpatient and emergency care visits
• Additional surgical procedures• Incision and drainage• Staged reimplantation
• Prolonged antibiotic therapy• Increased use of ancillary services
• Home health visits• Radiology, laboratory
• Drug costs• Durable medical equipment
16Confidential. For Internal Use Only.
Urban JA. Surg Infect (Larchmt). 2006;7(suppl 1):S19-S22.© ETHICON, INC. 2008 All Rights Reserved
© ETHICON, INC. 2007
Summary• The major pathogens that lead to SSIs are:
• Staphylococcus aureus• Staphylococcus epidermidis• Methicillin-resistant Staphylococcus aureus (MRSA)• Methicillin-resistant Staphylococcus epidermidis (MRSE)
• Staphylococcus aureus is a major pathogen that leads to surgical site infection• There are 4 classes of surgical wound categories• Comprehensive infection-control protocols include dozens of preoperative,
intraoperative, and postoperative components
• SSIs are costly to hospitals and patients: $400 – $30,000• Medicare is restricting the payment of hospital-acquired conditions• SSIs are costly in terms of longer hospitalization and increased mortality for
patients, and higher costs for hospitals
17Confidential. For Internal Use Only.
Nichols RL. Emerg Infect Dis. 2001;7:220-224.© ETHICON, INC. 2008 All Rights Reserved
© ETHICON, INC. 2007
IRGACARE® MP (triclosan) Properties
• IRGACARE MP• 2,4,4′-tri-chloro-2′-hydroxydiphenyl ether
• High-purity material that meets USP specifications for triclosan, with minimal residue content
• IRGACARE MP is safe• Biocompatible, nontoxic
• Consumer products
• IRGACARE MP is effective• Active against methicillin-sensitive and methicillin-resistant S aureus and S epidermidis (most common for device infections)
• Active against Escherichia coli and Klebsiella pneumoniae
• IRGACARE MP is compatible with suture processing• Maintains excellent suture properties
18Confidential. 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.
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IRGACARE® MP (triclosan): Mode of Action
•Chlorinated phenolic biocide—a “phenol” with multitargeted biocidal mechanisms•Actions widely unknown•Nonspecific effects on cell membrane activities and cell membrane integrity
•Blocks active site of the enoyl-acyl carrier protein reductase—an essential enzyme in fatty acid synthesis—building cellular components and reproduction
19Confidential. For Internal Use Only.
Zurita R et al. Macromol Biosci. 2006;6:58-69.
® Ciba Corporation Inc
© ETHICON, INC. 2008 All Rights Reserved
© ETHICON, INC. 2007
Why IRGACARE® MP (triclosan)?
•Able to withstand the manufacturing process•Cost-effective•Effective, safe, and compatible•Performance/function properties
•Handling•Absorption profile, breaking-strength retention
20Confidential. For Internal Use Only.
Storch M et al. Surg Infect (Larchmt). 2002;3(suppl 1):S65-S77.
® Ciba Corporation Inc
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IRGACARE® MP (triclosan): Pharmacokinetics
•Well absorbed after oral administration•Well distributed in the body•Rapidly metabolized in liver to the glucuronide/sulfate conjugate•T½=10 to 13 hours
•Excreted through kidneys
21Confidential. For Internal Use Only.
Barbolt TA. Surg Infect (Larchmt). 2002;3(suppl 1):S45-S53.
® Ciba Corporation Inc
© ETHICON, INC. 2008 All Rights Reserved
© ETHICON, INC. 2007
IRGACARE® MP (triclosan) and Microbial Resistance
• IRGACARE MP is very effective against S aureus, S epidermidis, and E coli, which are the 3 most important bacteria related to SSIs
• There is no connection between the use of IRGACARE MP and significant antibiotic resistance
• The use of IRGACARE MP may lead to the overall reduction of the antibiotic burden•Decreases the risk of SSIs and the resulting application of stronger antibiotics against SSIs
•The use of IRGACARE MP is not associated with increased bacterial
virulence that raises the antibiotic burden
22Confidential. 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.
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Triclosan-Coated Sutures for the Reduction of Sternal Wound Infections: Economic Considerations
Fleck T, Moidl R, Blacky A, et al. Ann Thorac Surg. 2007;84:232-236.
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Results• Total patients enrolled 479
•103 closed with Coated VICRYL* Plus Antibacterial (polyglactin 910) Suture
•376 closed with non-coated sutures• Reported a cost of infection of $11,200
•“24 patients had superficial infections (n=10) or deep (n=14) sternal wound infections”
• “In the triclosan group, no wound infection or dehiscence was observed during hospital stay and follow-up visits”
• This information concerns a use that has not been cleared by the FDA (Infection Reduction Claim)
24
Fleck T et al. Ann Thorac Surg. 2007;84:232-236.
*Trademark
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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.
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Results and Conclusions
•Total patients enrolled = 61•Total procedures performed = 84
•Over 21 months
•Shunt infection rate•2 (4.3%) infections in 46 procedures for study group•8 (21%) infections in 38 procedures for control group (P=0.038)
•This information concerns a use that has not been cleared by the FDA (Infection Reduction Claim)
26Confidential. For Internal Use Only.
Rozzelle CJ et al. J Neurosurg Pediatrics. 2008;2:111-117.
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Antibiotic coating of abdominal closure sutures and wound infection
Dr Justinger (Germany) from department of General, Visceral, Vascular and Pediatric Surgery
© ETHICON, INC. 2007
Results and Conclusions
• Objective: Dr Justinger compared the use of Coated VICRYL* Plus Antibacterial (polyglactin 910) Suture with PDS*II (polydioxanone) Suture (loop suture) for the closure of midline laparotomy to evaluate the reduction in wound infections.
• Patients: 2088 operations between October 2004 and September 2006
• Procedures: Abdominal wall closure (midline incision)• Findings: with PDS Suture (loop suture) for abdominal wall
closure, 10.8% of patients with wound infections were detected. The number of patients with infections using Coated VICRYL Plus Suture decreased to 4.9% despite no changes in protocols of patient care.
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