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Surgical Site Infection: New Solutions to a Continuing Problem

Surgical Site Infection: New Solutions to a Continuing Problem. R. Lawrence Reed, II, MD, FACS, FCCM Professor of Surgery Loyola University Medical Center Director, SICU, Hines VA Medical Center Maywood, IL. Surgical Site Infections (SSI) . Third most common nosocomial infection (14%–16%)

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Surgical Site Infection: New Solutions to a Continuing Problem

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  1. Surgical Site Infection:New Solutions to a Continuing Problem R. Lawrence Reed, II, MD, FACS, FCCM Professor of Surgery Loyola University Medical Center Director, SICU, Hines VA Medical Center Maywood, IL

  2. Surgical Site Infections (SSI) • Third most common nosocomial infection (14%–16%) • Most common nosocomial infection among surgical patients (38%) • 2/3 incisional • 1/3 organs or spaces accessed during surgery • 7.3 additional postoperative days at cost of $3,152 in extra charges Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  3. Colonization vs Contamination – Definitions • Colonization • Bacteria present in a wound with no signs or symptoms of systemic inflammation • Usually less than 105 cfu/mL • Contamination • Transient exposure of a wound to bacteria • Varying concentrations of bacteria possible • Time of exposure suggested to be < 6 hours • SSI prophylaxis best strategy

  4. SSI – Definitions • Infection • Systemic and local signs of inflammation • Bacterial counts ≥ 105 cfu/mL • Purulent versus nonpurulent • LOS effect • Economic effect • Surgical wound infection is SSI LOS=length of stay.

  5. Skin Superficial incisional SSI Subcutaneous tissue Superficial Incisional SSI Infection occurs within 30 days after the operation and involves only skin or subcutaneous tissue of the incision Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  6. Deep soft tissue (fascia & muscle) Deep incisional SSI Deep Incisional SSI Infection occurs within 30 days after the operation if no implant is left in place or within 1 year if implant is in place and the infection appears to be related to the operation and the infection involves the deep soft tissue (e.g., fascia and muscle layers) Superficial incisional SSI Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  7. Organ/space SSI Organ/space Organ/Space SSI Infection occurs within 30 days after the operation if no implant is left in place or within 1 year if implant is in place and the infection appears to be related to the operation and the infection involves any part of the anatomy, other than the incision, which was opened or manipulated during the operation Superficial incisional SSI Deep incisional SSI Mangram AJ et al. Infect Control Hosp Epidemiol.1999;20:250-278.

  8. Duration of surgical scrub Maintain body temp Skin antisepsis Preoperative shaving Duration of operation Antimicrobial prophylaxis Operating room ventilation Inadequate sterilization of instruments SSI – Risk FactorsOperation Factors • Foreign material at surgical site • Surgical drains • Surgical technique • Poor hemostasis • Failure to obliterate dead space • Tissue trauma Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  9. SSI – Risk FactorsPatient Characteristics • Prolonged preoperative stay: surrogate of the severity of illness and comorbid conditions • Preoperative nares colonization with Staphylococcus aureus: significant association • Perioperative transfusion: controversial • Coexistent infections at a remote body site • Altered immune response • Age • Diabetes • HbA1C and SSI • Glucose > 200 mg/dL postoperative period (<48 hours) • Nicotine use: delays primary wound healing • Steroid use: controversial • Malnutrition: no epidemiological association • Obesity: 20% over ideal body weight Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  10. Risk of Infection Bacterial dose Virulence Impaired host resistance

  11. Risk of Infection Bacterial dose Virulence Impaired host resistance

  12. Risk of Surgical Infection Bacterial dose Virulence Bacterial dose Impaired host resistance Risk of Infection Virulence Impaired host resistance

  13. Prophylactic antibiotics indicated Therapeutic antibiotics SSI – Wound Classification • Class 1 = Clean • Class 2 = Clean contaminated • Class 3 = Contaminated • Class 4 = Dirty infected Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  14. SSI – Risk Stratification NNIS Project 3 independent variables associated with SSI risk • Contaminated or dirty/infected woundclassification • ASA > 2 • Length of operation > 75th percentile of the specific operation being performed NNIS=National Nosocomial Infections Surveillance. NNIS. CDC. Am J Infect Control. 2001;29:404-421.

  15. SSI – Wound Class vs NNIS Class Wound Class All NNIS 0 NNIS 1 NNIS 2 NNIS 3 Clean 2.1% 1.0% 2.3% 5.4% N/A Clean contaminated 3.3% 2.1% 4.0% 9.5% N/A Contaminated 6.4% N/A 3.4% 6.8% 13.2% Dirty infected 7.1% N/A 3.1% 8.1% 12.8% All 2.8% 1.5% 2.9% 6.8% 13.0% NNIS. CDC. Am J Infect Control. 2001;29:404-421.

  16. Campaign to PreventAntimicrobial Resistance • Centers for Disease Control and Prevention • National Center for Infectious Diseases • Division of Healthcare Quality Promotion Clinicians hold the solution! • Link to: Campaign to Prevent Antimicrobial Resistance Online • Link to:Federal Action Plan to Combat Antimicrobial Resistance

  17. 12 Steps to Prevent Antimicrobial Resistance AmongSurgical Patients • Step 1 – Prevent SSIs • Monitor and maintain normal glycemia • Maintain normothermia • Perform proper skin preparation using appropriate antiseptic agent and, when necessary, hair removal techniques • Think outside the wound to stop surgical site infections CDC. Available at http://www.cdc.gov/drugresistance/healthcare/surgery/12steps_surgery.htm. Accessed July 16, 2004.

  18. Opportunity to Prevent SSI • An estimated 40%–60% of SSIs are preventable • Overuse, underuse, improper timing, and misuse of antibiotics occurs in 25%–50% of operations Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  19. Preop administration, serum levels adequate throughout procedure with a drug active against expected microorganisms. • High Serum Levels • Preop timing • IV route • Highest dose of drug • During Procedure • Long half-life • Long procedure–redose • Large blood loss–redose • Duration • None after wound closed • 24 hours maximum Principles of Antibiotic Prophylaxis Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  20. Surgical Site Infection (SSI) Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

  21. Surgical Infection Prevention ProjectMedicare Quality Improvement Community Clinical Infectious Diseases 2004 June; 38:1706–15

  22. National Data Collection • State-level baseline description from random sample of 788 cases per state • Data collected from records by two professional clinical data abstraction centers • Abstraction tool for hospitals is available….Is JCAHO compatible

  23. N (%) Number of cases reviewed 39,086 (100) General Exclusions Surgery of interest not performed Infection present pre-operatively Missing antibiotic dates and times Patient on antibiotics prior to admission Patient on antibiotics for more than 24 hours pre-op Other 205 (0.52) 1,817 (4.7) 2 (0.01) 1,461 (3.74) 1,432 (3.66) 36 (0.09) Cases eligible for analysis 34,133 (87.3) Surgical Infection PreventionPreliminary Results

  24. Discontinuation of Antibiotics Patients were excluded from the denominator of this performance measure if there was any documentation of an infection during surgery or in the first 48 hours after surgery.

  25. Most Common Pathogens Associated With Nosocomial Infections (NNIS 1989–1998) Medical & Surgical Combined Relative Percentage by Site of Infection Pathogen All Sites BSI Pneumonia SSI n=235,758 n=50,091 n=64,056n=22,043 Coag-neg Staph 14.3 39.3 2.5 13.5 S aureus 11.4 10.7 16.8 12.6 Enterococci spp. 8.1 10.3 1.9 14.5 P aeruginosa 9.9 3.0 16.1 9.2 Enterobacter spp. 7.3 4.2 10.7 8.8 E coli 7.0 2.9 4.4 7.1 C albicans 6.6 4.9 4.0 4.8 K pneumoniae 4.7 2.9 6.5 3.5 Others 30.7 21.8 37.1 26.0 BSI=bloodstream infection; SSI=surgical site infection. Fridkin SK et al. Clin Chest Med. 1999;20:303-316.

  26. Other 17.3% MSSA 30.9% Klebsiella 5.1% Enterobacter 5.8% S aureus 45.9% E coli 7.0% MRSA ~15% Enterococci 8.2% 10.8% P aeruginosa Predominance of S aureus in Skin and Skin Structure Infections (SSSIs)SENTRY – US and Canada 2000 N=1,404 isolates Rennie RP et al. Diagn Microbiol Infect Dis. 2003;45:287-293.

  27. 57.1% 55.3% Progression of Methicillin Resistant S aureus – United States 13% CDC. MMWR. 1997;46:624-628, 635. (1975 data); Lowy FD. N Engl J Med. 1998;339:520-532. (1987-1997 data); CDC. NNIS System Report, January–November 1998. (1998 data); CDC. NNIS System Report, January 1990–May 1999, issued June 1999. Am J Infect Control. 1999;27:520-532. (1999 data); CDC. NNIS System Report, January 1992–June 2001. Am J Infect Control. 2001;29:404-421. (2000 data); NNIS. CDC. Am J Infect Control. 2003;31:481-498.

  28. Median Hospital Charges 100,000 92,363 90,000 80,000 70,000 60,000 52,971 50,000 40,000 29,455 30,000 20,000 10,000 0 MSSA MRSA Control Impact of MRSA on SSI • N=479 patients • MRSA greater 90-d mortality vs MSSA (adjusted odds ratio, 3.4; 95% CI: 1.5–7.2) • MRSA longer LOS after infection (median additional days=5; P<0.001) • MRSA associated with greater hospital charges (1.19-fold increase in hospital charges, P=0.03) Engemann JJ et al. Clin Infect Dis. 2003;36:592-598.

  29. Vascular SSI • Retrospective review (1993–2000) • Leicester Royal Infirmary, United Kingdom • 172 patients MRSA-positive (4.4% of total) • 75 infected, 97 colonized • Proportion of wound/graft infections caused by MRSA has increased • 4% in 1994, increased to 63% in 2000 • All patients with aortic graft infection died • All patients with infected prosthetic infrainguinal bypass required amputations Nasim A et al. Eur J Vasc Endovasc Surg. 2001;22:211-214.

  30. MRSA in Orthopedic SSI • Prospective study, London, United Kingdom • 12-month study, January through December 2000 • Total of 1,879 patients admitted, 121 screened • 1.6% of total with MRSA infection/colonization • Higher risk for MRSA infection • Hip surgery • Emergency surgery for femoral neck fracture • Presence of wound • MRSA infection – increased hospital LOS (88 vs 11 days) • 41% of positive patients still carried MRSA on discharge Tai CC et al. Int Orthop. 2004;28:32-35.

  31. MRSA in Cardiac Surgery • 3,443 CABG patients, all received antimicrobial prophylaxis • June 1997 through December 2000 • Sternal SSI developed in 122 (3.5%) • 71 (58.2%) were superficial SSI • 51 (41.8%) were deep SSI • Gram-positive cocci were most frequently recovered (81%) • S aureus was the most frequently isolated pathogen (49%) • S aureus bacteremia occurred in 18% and was significantly associated with deep SSI (P=0.002) CABG=coronary artery bypass grafting. Sharma M et al.Infect Control Hosp Epidemiol. 2004;25:468-471.

  32. Survival Rates Impact of MRSA in Cardiac Surgery • Retrospective review (41 patients) • Poststernotomy S aureus mediastinitis • MRSA: 15 patients • MSSA: 26 patients • Logistic regression analysis: MRSA was the only independent risk factor for increased mortality, P=0.04 Mekontso-Dessap A et al. Clin Infect Dis. 2001;32:877-883.

  33. All postoperative S aureus Infections 7.7 P=0.02 Percent of patients with S aureus (%) 4 Mupirocin Placebo Nasal Mupirocin and SSI • 4,030 patients enrolled, 3,864 ITT patients • PRDBPCT, intranasal mupirocin • 891 patients (23.1%) had S aureus in anterior nares • 444 mupirocin, • 447 placebo • S aureus SSI: • 2.3% mupirocin • 2.4% placebo ITT=intent-to-treat; PRDBPCT=prospective, randomized, double-blind placebo-controlled trial. Perl TM et al. N Engl J Med. 2002;346:1871-1877.

  34. Surgical Wound ManagementSSI Prophylaxis in MRSA-Colonized Patient • Must use same principles • Drug choice difference • MRSA drugs • Vancomycin • Quinupristin/dalfopristin* • Linezolid • Daptomycin *Not FDA approved for MRSA.

  35. Vancomycin • Bactericidal glycopeptide • Discovered in 1956 • Produced by Streptococcus orientalis, an actinomycete isolated from soil samples from Indonesia & India • Introduced clinically in 1958 • Quickly overshadowed by less toxic anti-staphylococcal penicillins and cephalosporins • Re-emergence as an important antibiotic in 1980s & 1990s

  36. Historical Yearly Usage of Vancomycin 2001: 1.8 million courses of vancomycin annually in U.S. 30 million doses of vancomycin estimated Kirst HA et al. Antimicrob Agents Chemother. 1998;42:1303-1304; NNIS. Am J Infect Control. 2001;29:404-421.

  37. 12 Steps to Prevent Antimicrobial Resistance AmongSurgical Patients • Step 9. Know when to say “no” to vanco • Vanco should be used to treat known infections, not for routine prophylaxis • Treat staphylococcal infection, not contaminants or colonization • Consider other antimicrobials in treating MRSA CDC. Available at http://www.cdc.gov/drugresistance/healthcare/surgery/12steps_surgery.htm. Accessed July 16, 2004.

  38. Vancomycin Tissue Penetration • 33 open-heart surgery patients, mean vancomycin concentrations after 15 mg/kg IV dose • Below the mean MICs for many strains of staphylococci MIC=minimum inhibitory concentration. Daschner FD et al. J Antimicrob Chemother. 1987;19:359-362.

  39. CNS:<10% Epitheliallining fluid3:18% Lung tissue2:17%–24% Bone5:7%–13% Fat4: 14% Muscle4:9% Sternal Bone1:57%Heart Valve4: 12% Vancomycin Penetration 1. Massias L et al. Antimicrob Agents Chemother. 1992;36:2539-2541; 2. Cruciani M et al. J Antimicrob Chemother. 1996;38:865-869. 3. Lamer C et al. Antimicrob Agents Chemother. 1993;37:281-286; 4. Daschner FD et al. J Antimicrob Chemother. 1987;19:359-362; 5. Graziani AL et al. Antimicrob Agents Chemother. 1988;32:1320-1322.

  40. Quinupristin/Dalfopristin (Synercid®) • Streptogramin class related to macrolide-lincosamides • Quinupristin is a Group B streptogramin • Dalfopristin is a Group A streptogramin • Activity against: • MSSA – potently bactericidal • Streptococcus pneumoniae (including PRSP) – potently bactericidal • MRSA – moderately active • E faecium – moderately active against most E faecium strains • NO activity against E faecalis PRSP=penicillin-resistant Streptococcus pneumoniae. Synercid® IV (quinupristin/dalfopristin for injection) [package insert]. Bristol, Tenn: Monarch Pharmaceuticals, Inc; 2002.

  41. Quinupristin/Dalfopristin (Synercid®) • Central line access used to decrease incidence of infusion-related venous irritation • 3%–30% incidence of severe myalgias and arthralgias • Resistance has already been reported • Bacteriostatic • Does not have indication for pneumonia • Did not perform as well as vancomycin Synercid® IV (quinupristin/dalfopristin for injection) [package insert]. Bristol, Tenn: Monarch Pharmaceuticals, Inc; 2002.

  42. Daptomycin (Cubicin™) • Lipopeptide natural product • Activity in Gram-positive organisms • Distinct mechanism of action • Rapidly bactericidal in vitro and in vivo • No mechanisms of resistance identified • No cross-resistance with other antibiotics • Safety profile similar to comparators • Once-daily IV dosing Cubicin™ (daptomycin for injection) [prescribing information]. Lexington, MA: Cubist Pharmaceuticals; September 2003.

  43. Linezolid (ZYVOX®) • An oxazolidinone: a novel antimicrobial class • 100% oral bioavailability • Equivalent dosing oral/IV • No dose adjustment in renal failure • Bacteriostatic • No cross-resistance with other antibiotics • Reversible thrombocytopenia with prolonged use • Binds selectively to the 50S ribosomal subunit • Inhibits the formation of a functional initiation complex ZYVOX® (linezolid injection, tablets, and oral suspension) [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn, a Pfizer Company; revised June 2004.

  44. Average Steady-State Plasma Linezolid Concentrations After Oral Administration of 400 or 600 mg Twice Daily 600 mg BID 400 mg BID MIC-90 Staph MIC-90 Entero MIC-90 Strep Linezolid concentration (μg/mL) Time After Last Dose (hours) Linezolid Research Update. Denver, Colo: Infectious Diseases Society of America; November 13, 1998.

  45. CNS1:70%* Epitheliallining fluid4:450% Alveolar cells4:15% Saliva2:120% Sweat2:55% Skin Blister Fluid5:100% Bone3:40%–60% Linezolid Penetration 1. Cottagnound et al. J Antimicrob Chemother. 2000;46:981-985; 2. ZYVOX® (linezolid injection, tablets, and oral suspension) [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn, a Pfizer Company; revised 2003; 3. Lovering AM et al. J Antimicrob Chemother. 2002, 50:73-77; 4. Conte JE et al. Antimicrob Agents Chemother. 2002;46:1475-1480; 5. Gee T. Antimicrob Agents Chemother. 2001;45:1843-1846.

  46. Comparison of Tissue Concentrations (% Tissue/Serum) 1. Graziani AL et al. Antimicrob Agents Chemother. 1988;32:1320-1322; 2. Matzke et al. Clin Pharmacokinet. 1986;11:257-282; 3. Albanese J et al. Antimicrob Agents Chemother. 2000;44:1356-1358; 4. Georges H et al. Eur J Clin Microbiol Infect Dis. 1997;16:385-388; 5. Lamer C et al. Antimicrob Agents Chemother. 1993;37:281-286; 6. Daschner FD et al. J Antimicrob Chemother. 1987;20:776-782; 7. Blevins RD et al. Antimicrob Agents Chemother. 1984;25:603-606; 8. Lovering AM et al. J Antimicrob Chemother. 2002;50:73-77; 9. Conte JE et al. Antimicrob Agents Chemother. 2002;46:1475-1480; 10. Gee T et al. Antimicrob Agents Chemother. 2001;45:1843-1846; 11. Gendjar SR et al. 2001 ASN/ISN World Congress of Nephrology; 2001; San Francisco, Calif. Abstract 550865.

  47. Complicated Skin and Soft Tissue Infection (cSSTI) Treatment • Staph most common cause • Staph resistance continues to increase • 57.1% in 2002 • Treatment for MRSA cSSTI prior to 2000 • Vancomycin • Quinupristin/dalfopristin* • New alternatives for treatment of MRSA cSSTI • Linezolid • Daptomycin *Not FDA approved for MRSA. NNIS. CDC. Am J Infect Control. 2003;31:481-498.

  48. Quinupristin/Dalfopristin† (Q/D) Efficacy • Design: 2 randomized, open-label, controlled clinical trials in cSSSI • Study 1: Q/D (7.5 mg/kg q12h IV) vs oxacillin (2 g q6h IV)* • Study 2: Q/D (7.5 mg/kg q12h IV) vs cefazolin (1 g q8h IV)* Efficacy in the Clinically Evaluable Population† *Vancomycin 1 g q12h IV could be substituted if the pathogen was suspected or confirmed methicillin-resistant Staphylococcus or the patient was allergic to penicillin, cephalosporins, or carbapenems. †Patients cured or improved. ‡Results are combined from the 2 clinical trials. Statistical conclusions could not be reached due to the small number of patients in the subsets. †Not FDA approved for MRSA. Synercid® IV (quinupristin/dalfopristin for injection) [package insert]. Bristol, Tenn: Monarch Pharmaceuticals, Inc; 2002.

  49. Quinupristin/Dalfopristin† (Q/D) Efficacy • Design: 2 randomized, open-label, controlled clinical trials in cSSSI Summary of Clinical and Microbiologic Results* *Results are combined from the 2 clinical trials. †Patients cured or improved in the clinically evaluable population. ‡Overall and by-pathogen bacteriologic eradication rates in the microbiologically evaluable population. cSSSIs=complicated skin and skin structure infections. Nichols RL et al. J Antimicrob Chemother. 1999;44:263-273. †Not FDA approved for MRSA.

  50. If MSSA, vancomycin could be switched to oxacillin/nafcillin/flucloxacillin (IV only) 1–2 g q6h or dicloxacillin (oral) 500 mg q6h 4- to 14-day treatment duration Linezolid vs Vancomycin for cSSTI Presumed or Known to Be Caused by MRSA • Study design:Open-label, randomized, comparator-controlled, multicenter, multinational clinical study • Population: 1,200 hospitalized adult patients with cSSTI • Treatment arms: Vancomycin (IV only) 1 g every 12 hours Linezolid (oral or IV) 600 mg every 12 hours OR Weigelt JA et al. Infectious Diseases Society of America, 2003, poster 314. San Diego, CA.

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