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During June 1985 through October 1986, 292 patients considered to be at high risk for having postoperative complications develop underwent cholecystectomy and were evaluated in a multicenter, randomized, prospective, double-blind study. Risk factors included age greater than 70 years, acute cholecystitis within the previous six months, obstructive jaundice, obesity and diabetes mellitus. One gram of cefamandole was administered intravenously to 144 patients and 148 patients received 1 gram of cefotaxime intravenously 30 minutes prior to skin incision. Culture-proved bactibilia was found in 55 patients and 11 of the patients had choledocholithiasis. Of the risk factors considered to place patients at high risk for postoperative infectious complications, obesity and acute cholecystitis proved to be the more common. However, age greater than 70 years, diabetes mellitus and obstructive jaundice were more significant risk factors predisposing to bactibilia. The most common organisms isolated from the bile and gallbladder intraoperatively were Staphylococcus, Streptococcus and Klebsiella species along with enterococcus, Escherichia coli and diphtheroids. Clinically significant postoperative infections occurred in eight patients, including six patients in the cefamandole group and two patients in the cefotaxime group. Antibiotic concentrations were measured in the serum, muscle, subcutaneous fat, gallbladder and bile, with cefamandole showing statistically significant greater concentrations in bile, gallbladder and muscle tissue. There was no statistical significance between the postoperative infection rates, total period of hospitalization or total hospital charges for each group. Therefore, there is no significant advantage between a single prophylactic dose of cefamandole versus cefotaxime for high-risk patients undergoing biliary tract operation. |
