[Comparison of two antimicrobial prophylaxis regimens in biliary tract surgery: a randomized controlled 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.


METHODS
A randomized nonblinded clinical trial with a blind independent observer.


METHODS
Tertiary-care center.


METHODS
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).


METHODS
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.
Orozco
H
H
Departamento de Infectología, Instituto Nacional de la Nutrición Salvador Zubirán, México, D.F. México.
Sifuentes Osornio
J
J
Prado
E
E
Takahashi
T
T
López Graniel
C M
CM
Anaya
E
E
Canto
J
J
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use; D001652:Bile Ducts / Q000601:surgery; D002512:Cephalothin / Q000008:administration & dosage / Q000627:therapeutic use; D002763:Cholecystectomy; D019818:Clavulanic Acid; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000627:therapeutic use; D002981:Clindamycin / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011292:Premedication; D016037:Single-Blind Method; D013530:Surgical Wound Infection / Q000517:prevention & control*; D016896:Treatment Outcome
D002969:Clavulanic Acids; D019818:Clavulanic Acid; D002981:Clindamycin; D000658:Amoxicillin; D002512:Cephalothin
Comparación de dos esquemas de profilaxis antimicrobiana en cirugía de vías biliares: un ensayo clínico controlado por sorteo.