Clinical trial of cefamandole, cefazolin, and cefuroxime for antibiotic prophylaxis in cardiac operations.

A relatively large number of comparative trials of antibiotic prophylaxis in cardiac surgery have been published, many of which have serious design flaws. Despite the large number of studies, no single antibiotic regimen has emerged as clearly superior in preventing postoperative site infections. To determine if a superior regimen could be identified with a study designed to avoid flaws found in previous studies, we undertook a randomized, double-blind clinical trial of three cephalosporins. From March 1987 to February 1990, 2759 adults underwent median sternotomies: 1641 completed study participation, 203 were enrolled but were dropped from the study for protocol violations, and 815 were excluded. The characteristics of all 2759 patients were recorded with respect to case mix and infection risk factors, and the patients were followed-up by the same nurse throughout hospitalization and for 6 weeks after discharge for the assessment of infection outcome status. Of the 1641 participants, 141 (8.6%) had one or more operative site infections: 46 of 549 (8.4%) cefamandole recipients, 46 of 547 (8.4%) cefazolin recipients, and 49 of 545 (9.0%) cefuroxime recipients (p = 0.92). The sites of infection and the depth of tissue involvement were not significantly different across groups. Because no differences in effectiveness in preventing postoperative site infections were demonstrated in a rigorously designed trial, the costs of the drugs, including the costs of their preparation and delivery, may be the only variables by which to choose among these three antibiotic prophylaxis regimens.

RCT Entities:   Population Interventions Outcomes