COMPARISON OF 2 SCHEMES OF ANTIMICROBIAL PROPHYLAXIS IN BILIARY-TRACTSURGERY - A RANDOMIZED CLINICAL-TRIAL

Objective. The aim of this study was to analyze the efficacy in prophy laxis during biliary tract and gallbladder surgery with amoxicillin/cl avulanate and to compare it with the combination of cephalothin and cl indamycin. Design. A randomized nonblinded clinical trial with a blind independient observer. Place. Tertiary-care center Patients. Forty-tw o patients were included. All had undergone biliary tract and/or gallb ladder surgery. They were divided in two groups: 22 in group A (cephal othin and clindamycin), and 20 in group B (amoxicillin/clavulanate). I nterventions. Patients from group A were intravenously treated with th ree doses of cephalothin (2 g at anesthetic induction and two addition al doses of 1 g at six-hour intervals), and three of clindamycin (600 mg every six hours). Patients from group B received three doses of amo xicillin/clavulanate (1000/200 mg IV, one during the induction of the anesthesia followed by two more at six-hour intervals). Results. In gr oup A six wound infections were recorded, one of them with secondary b acteremia. In group B we did not record any infection (Fisher p<0.01). One case of phlebitis was recorded in each group. Conclusions. Our re sults indicate that amoxicillin/clavulanate is useful in the prophylax is of gallbladder and biliary tract surgery, and more effective than t he combination of cephalothin and clindamycin.