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[Comparison of two antimicrobial prophylaxis regimens in biliary tract surgery: a randomized controlled clinical
H Orozco1, J Sifuentes Osornio, E Prado
1Departamento de Infectología, Instituto Nacional de la Nutrición Salvador Zubirán, México, D.F. México.
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.