Comparative multicenter trial of teicoplanin versus cefazolin for antimicrobial prophylaxis in prosthetic joint implant surgery. Italian Study Group for Antimicrobial Prophylaxis in Orthopedic Surgery.

A randomized multicenter study was carried out in 12 centers in Italy to compare administration of a single dose of teicoplanin (400 mg i.v. bolus at time of anesthesia) versus that of five doses of cefazolin over a 24-h period (2 g at induction of anesthesia and 1 g every 6 h postoperatively, i.v. bolus) as antimicrobial prophylaxis in patients undergoing hip or knee arthroplasty. Of 860 patients enrolled, 427 received teicoplanin and 433 cefazolin. A total of 846 patients (422 teicoplanin and 424 cefazolin) were evaluable for safety and 826 patients for efficacy. Six patients (1.5%) in the teicoplanin group and seven patients (1.7%) in the cefazolin group developed a surgical wound infection during their postoperative hospital stay: this difference was not significant. Proven or suspected infections involving other body systems occurred in 114 patients (57 in each group). Seven hundred ninety-two patients completed a 3-month evaluation and 738 patients a 12-month evaluation: the success rates in evaluable patients at these observation times were 99.2% and 99.7% for teicoplanin and 99.2% and 99.7% for cefazolin, respectively. Adverse events occurred in three (0.7%) teicoplanin patients and nine (2.1%) cefazolin patients (P = 0.083). A single preoperative dose of teicoplanin ensures adequate surgical antisepsis, with results comparable to a standard multiple-dose regimen of cefazolin.

RCT Entities:   Population Interventions Outcomes