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Pierluigi Viale Clinica di Malattie Infettive Università degli Studi di Udine

2° Infectivology today Paestum 18-20 maggio 2006. Etiopatogenesi e profilassi dell’infezione post-operatoria. Pierluigi Viale Clinica di Malattie Infettive Università degli Studi di Udine. Impact of SSI’s. Prevention of SSI’s. Perioperative antimicrobial prevention measures

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Pierluigi Viale Clinica di Malattie Infettive Università degli Studi di Udine

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  1. 2° Infectivology today Paestum 18-20 maggio 2006 Etiopatogenesi e profilassi dell’infezione post-operatoria Pierluigi Viale Clinica di Malattie Infettive Università degli Studi di Udine

  2. Impact of SSI’s

  3. Prevention of SSI’s • Perioperative antimicrobial prevention measures • Maintain normal blood sugar levels • Hyper-oxygenation • Maintain normal body temperature • Hair removal immediately prior to operation using electric clippers • Hand washing • Good surgical technique • Control of host-related risk factors • Antibiotics

  4. NRC Wound Classification • Clean Surgical Procedures •  atb prophylaxis not indicated * • Clean Contimated Procedures •  prophylaxis indicated • Contaminated Procedures •  therapy indicated • Dirty Procedures •  therapy indicated • * Two well recognized ATB indications for such clean operations are: • 1. Any intravascular prosthetic material or prosthetic joint will be inserted • 2. Any operation in which an incisional or organ space SSI would pose catastrophic risk • Cardiac surgery • Neurosurgical Operations • Prosthetic arterial grafts • Revascularization of lower extremity

  5. Surgical Antimicrobial Prophylaxis Surgical AMP refers to a very brief course of an antimicrobial agent initiated just before an operation begins. AMP is not an attempt to sterilize tissues, but a critically timed adjunct used to reduce the microbial burden of intra-operative contamination to a level that cannot overwhelm host defenses.

  6. + DRUG RESISTANCE THE EQUATION OF THE INFECTIOUS RISK BACTERIAL LOAD x VIRULENCE = INFECTIOUS RISK = INFECTIOUS RISK HOST IMMUNITY HOST IMMUNITY + ANTIBIOTICS Every Operation is an Experiment in Bacteriology …

  7. THE FIVE MAIN TOPIC OF SURGICAL ANTIBIOTIC PROPHYAXIS INDICATION • INDICATION • TIMING OF ADMINISTRATION • TIME OF ADMINISTRATION (single vs multiple dose) • DRUG CHOICE • DRUG DOSAGE

  8. Antibiotic prophylaxis in orthopedics. An epidemiological survey in Italy J Chemother 2000; 12 (supppl 2):28-38 136,312 procedures  24.4% arthroscopy  57.1% prophylaxis

  9. Risk factors for wound infection : multivariate analysis Surgical site infection after groin hernia repair British J Surgery 2004; 91: 105–111 Site: Scotland Sample : 2665 pts Follow up: 30 days Method: on call n. Infections : 140 Infection rate: 5.3 % ATB prophylaxis: 4.2% NO prophylaxis 7.6% P = 0·002

  10. The role of antibiotic prophylaxis on wound infection after mesh hernia repair under local anesthesia on an ambulatory basisHernia 2004;8:20-2 Randomized choice : CEFAZOLIN single dose (50 pts) vs PLACEBO (49 pts) Infection rates : CEFAZOLIN 0 PLACEBO 8.1% P = .059

  11. A prospective randomized trial of prophylactic antibiotics in elective laparoscopic cholecystectomySurg Endosc 2003; 17:1716-8 Randomized choice : CEFOTAXIME 2 g single dose (49 pts) vs PLACEBO (43 pts) Follow up: 30 days Infection rates : CEFOTAXIME 2.04% PLACEBO 2.32%

  12. PIPERACILLIN TO PREVENT CHOLANGITIS AFTER ERCP. A RANDOMIZED, CONTROLLED TRIAL Ann Intern Med 1996; 125:442-7 PIPERACILLIN (single dose) vs PLACEBO 551 consecutive pts enrolled atb placebo ACUTE CHOLANGITIS RATE 6% 4.4% RR 0.73 (95% CI 0.36-1.51)

  13. Biliary tract infections: a guide to drug treatment Drugs 1999; 57: 81-91 “ antibacterial prophylaxis before ERCP should be reserved for patients with obstructive jaundice, since the risk of infectious complications seems to be strongly associated with this clinical condition… … failure to achieve a full biliary drainage is the most important factor predicting bacteremia, and antimicrobial treatment should be prolonged until the bile duct is obstructed”

  14. Antibiotic Prophylaxis After Endoscopic Therapy Prevents Rebleeding in Acute Variceal Hemorrhage: A Randomized Trial Hepatology 2004;39:746–753 Actuarial probability of remaining free of rebleeding P .0029

  15. THE FIVE MAIN TOPIC OF SURGICAL ANTIBIOTIC PROPHYAXIS • INDICATION • TIMING OF ADMINISTRATION • TIME OF ADMINISTRATION (single vs multiple dose) • DRUG CHOICE • DRUG DOSAGE

  16. PROCEDURA CHIRURGICA Popolazione batterica UFC/mL colonizzazione INFEZIONE contaminazione TEMPO 2 -6 ore 3 -5 giorni CINETICA di CRESCITA BATTERICA dopo CONTAMINAZIONE INTRA-OPERATORIA

  17. ANTIBIOTICO (mg/L) PROCEDURA CHIRURGICA Pop. Batterica conc. Sieriche dell’antibiotico conc. dell’antib. in trombi, ematomi, coaguli MIC UFC/mL TEMPO SOMMINISTRAZIONE ANTIBIOTICO BASI TEORICHE della PROFILASSI CHIRURGICA Popolazione batterica e concentrazione dell’antibiotico in siero, trombi, ematomi e coaguli

  18. TIMING Incisione cutanea 100 Siero Interstizio tessuti 10 C>MIC per tutto l’intervento Periodo vulnerabile MIC 1 Troppo precoce Timing corretto Troppo tardiva

  19. TIMING INCIDENCE OF INFECTIONS • > 2 h pre-incision 3,8% • < 2 h pre-incision 0,6% • < 3 h post-incision 1,5% • > 3 h post-incision 3,3% The timing of prophylactic administration of antibiotics and the risk of surgical-wound infection. Classen DC et Al, N Engl J Med 1992

  20. BASI TEORICHE della PROFILASSI CHIRURGICA ANTIBIOTICO (mg/L) Pop. Batterica conc. Sieriche dell’antibiotico conc. dell’antib. in trombi, ematomi, coaguli PROCEDURA CHIRURGICA MIC UFC/mL UFC/mL TEMPO 1^ SOMMINISTRAZIONE ANTIBIOTICO 2^ SOMMINISTRAZIONE ANTIBIOTICO

  21. Intraoperative Redosing of Cefazolin and Risk for Surgical Site Infection in Cardiac Surgery Zanetti et al, Emerging Infectious Diseases 2001

  22. FARMACOCINETICA DEGLI ANTIBIOTICI IMPIEGATI IN PROFILASSI CHIRURGICA

  23. THE FIVE MAIN TOPIC OF SURGICAL ANTIBIOTIC PROPHYAXIS • INDICATION • TIMING OF ADMINISTRATION • TIME OF ADMINISTRATION (single vs multiple dose) • DRUG CHOICE • DRUG DOSAGE

  24. Ideal Prophylactic Agent • Excellent in vitro activity vs Staphylococci and Streptococci • Relatively long serum half-life • Good tissue penetration • Relatively non-toxic and well handling • Inexpensive • With low ability to collateral damage (selective pressure)

  25. SURGICAL-SITE INFECTION RATES AND RISK FACTOR ANALYSIS IN CORONARY ARTERY BYPASS GRAFT SURGERY Infect Control Hosp Epidemiol 2004;25:472-476 4,474 patients undergoing CABG surgery aggregate SSI rate : 7.8 infections per 100 procedures ( CI 95 7.0–8.5) Mixed flora 13 No growth 8 S. aureus 56% 18 Enterobacteriaceae 5 CoNS

  26. S. aureus colonization and disease Intranasal Mupirocin to prevent post-operative S. aureus infections Perl et al, N Engl J Med, 2002 Randomized, double-blind, placebo controlled trial 3864 patients included in the ITT analysis (891 S. aureus carriers) 7,7 p = .002 Mupirocin 4 Placebo 2,4 2,3 overall S. aureus carriers

  27. Base-case analysis: clinical outcomes and costs for a hypothetical cohort of 10,000 patients undergoing coronary artery bypass graft surgery Zanetti et al, Emerging Infectious Diseases 2001

  28. Clinical, microbiological, and economic benefit of a change in antibiotic prophylaxis for cardiac surgery. Spelman D et al, Infect Control Hosp Epidemiol 2002;23:402 from CEFAZOLIN to … VANCOMYCIN + RIFAMPICIN 10.5 (95% CI 8.2-13.3) 4.9 (95% CI 3.2-7.1) infections per 100 procedures CEF VANCO+RIFA An estimated $576,655 (Australian) was saved between two 12-month periods

  29. Glycopeptides Are No More Effective than b-Lactam Agents for Prevention ofSurgical Site Infection after Cardiac Surgery: A Meta-analysis Clin Infect Dis 2004; 38:1357–63 Summary of the risk of surgical site infection (SSI) after receipt of glycopeptide or b-lactam prophylaxis for the outcome of SSIs cefazolin Glycopeptide

  30. THE FIVE MAIN TOPIC OF SURGICAL ANTIBIOTIC PROPHYAXIS • INDICATION • TIMING OF ADMINISTRATION • TIME OF ADMINISTRATION (single vs multiple dose) • DRUG CHOICE • DRUG DOSAGE

  31. Pharmacokinetic-pharmacodynamic aspects of antimicrobial prophylaxis with teicoplanin in patients undergoing major vascular surgery Pea F, Furlanut M, Stellini R, Signorini L,Pavan F, Giulini SM, Viale P, Carosi G, Int J Antimicrob Ag, 2005 Type of study: prospective two-arms Goal: assessing plasma exposure to teicoplanin with two different prophylactic regimens [Group A (n = 23), 800 mg pre-operatively vs Group B (n = 24), 400 mg pre-operatively plus two doses of 200 mg 24 h apart)] Setting: patients undergoing major vascular surgery. Pts N: 47

  32. 800 mg 400 mg Pharmacokinetic-pharmacodynamic aspects of antimicrobial prophylaxis with teicoplanin in patients undergoing major vascular surgery Pea F, Furlanut M, Stellini R, Signorini L,Pavan F, Giulini SM, Viale P, Carosi G, Int J Antimicrob Ag, 2005 30 20 10 r = 0.32 8 7 6 5 Teicoplanin concentration (mg/L) 4 3 r = 0.56 2 1 2 3 4 5 6 7 8 9 Time of wound closure (h)

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