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. PATIENTS: 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 at 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.
RCT Entities:
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. PATIENTS: 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 at 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.
Authors: H Orozco; J Sifuentes-Osornio; C Chan; H Medina-Franco; F Vargas-Vorackova; E Prado; J Arch Journal: J Gastrointest Surg Date: 2000 Nov-Dec Impact factor: 3.452