COMPARISON OF SINGLE-DOSE CEFOTETAN AND MULTIDOSE CEFOXITIN AS INTRAVENOUS PROPHYLAXIS IN ELECTIVE, OPEN BILIARY-TRACT SURGERY - A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY

Objective: To compare the safety, tolerance and prophylactic effective ness of a single 2-g dose of cefotetan with a standard prophylactic re gimen of cefoxitin in reducing the incidence of postoperative infectio ns after elective, open biliary tract surgery. Design: Multicentre, do uble-blind, randomized comparative study with a 4-week follow-up. Sett ing: Five Canadian university centres. Participants: One hundred and e leven patients scheduled to undergo elective, open biliary tract surge ry. Interventions: The patients were randomly assigned to receive eith er cefotetan or cefoxitin in a ratio of 2:1; 76 patients received cefo tetan and 35 received cefoxitin. Main Outcome Measures: Wound infectio n as defined by the Centers for Disease Control and Prevention and by clinical evaluation, adverse events and laboratory parameters. Results : Two incisional wound infections were reported by patients in the cef otetan group, for an overall infection rate of 1.8% (2 of 111). No sig nificant differences were found in the failure rate or in any other in dicator of efficacy. The incidence of adverse events for cefotetan (12 .6%) was not statistically different from that for cefoxitin (10.4%), and none of the 16 adverse events in the cefotetan group and 5 in the cefoxitin group was serious or severe. Only one event (rash) was possi bly related to the study drugs. Several hematologic and biochemical pa rameters were found to be normal preoperatively and abnormal postopera tively, but no relation was found between these variations and the stu dy drugs. These changes were mainly attributable to the operation. Con clusion: Cefotetan was found to be effective and comparable to cefoxit in, both in safety and in reducing the incidence of infection after el ective, open biliary tract surgery.