Comparison of two schemes of antimicrobial prophylaxis in biliary tract surgery: A randomized clinical trial

Objective. The aim of this study was to analyze the efficacy in prophylaxis during biliary tract and gallbladder surgery with amoxicillin/clavulanate and to compare it with the combination of cephalothin and clindamycin. Design. A randomized nonblinded clinical trial with a blind independent observer. Place. Tertiary-care center. Patient. Forty-two patients were included. All had undergone biliary tract and/or gallbladder surgery. They were divided in two groups: 22 in group A (cephalothin and clindamycin), and 20 in group B(amoxicillin/clavulanate). Interventions. Patients from group A were intravenously treated with three doses of cephalothin (2 g at anesthetic induction and two additional doses of 1 g six-hour intervals), and three of clindamycin (600 mg every six hours). Patients from group B received three doses of amoxicillin/clavulanate (1000/200 mg IV, one during the induction of the anesthesia followed by two more at six-hour intervals). Results. In group A six wound infections were recorded, one of them with secondary bacteremia. In group B we did not record any infection (Fisher p<0.01). One case of phlebitis was recorded in each group. Conclusions. Our results indicate that amoxicillin/clavulanate is useful in the prophylaxis of gallbladder and biliary tract surgery, and more effective than the combination of cephalothin and clindamycin.