Piperacillin versus cefazolin given perioperatively to high-risk patients who undergo open cholecystectomy: a double-blind, randomized trial.

Author(s): Krajden S, Yaman M, Fuksa M, Langer JC, Rowan J, Burul CJ, Wooster DL, Deitel M, Borowy ZJ, Smith LC

Affiliation(s): Department of Microbiology, St. Joseph's Health Centre, Toronto, Ont.

Publication date & source: 1993-06, Can J Surg., 36(3):245-50.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: To study the efficacy, microbiologic features and toxicity of prophylactic cefazolin versus prophylactic piperacillin in high-risk patients who undergo open cholecystectomy. DESIGN: Double-blind randomized trial with follow-up for 6 weeks postoperatively. SETTING: An 850-bed community hospital, located in a major Canadian city. Patients admitted to hospital who satisfied published criteria for being at high-risk for infection after open cholecystectomy were entered into the protocol, and those who satisfied the criteria and provided consent were entered into the study. Eighty-one patients were randomly assigned by computer to receive either piperacillin or cefazolin as the prophylactic agent. INTERVENTIONS: Open cholecystectomy. MAIN OUTCOME: Provides detailed information on the organisms found in the biliary tree in patients with acute cholecystitis, assesses the in-vitro activity of cefazolin versus piperacillin against the isolated organisms, expecting that piperacillin would be much more active against isolated anaerobes and gram-negative bacteria. RESULTS: Bactobilia was documented in 42% of patients in the cefazolin group and 29% of patients in the piperacillin group. Piperacillin was active in vitro against 94% of all isolates versus 56% for cefazolin (p < 0.005, McNemar's test). Adverse effects and toxicities in both the piperacillin and cefazolin group were low and were not serious. CONCLUSIONS: Both piperacillin and cefazolin are safe and effective prophylactic antimicrobials for high-risk patients who undergo open cholecystectomy. However, piperacillin had a much wider spectrum of in-vitro activity against the isolated pathogens, especially Enterococcus sp., Enterobacter cloacae and the anaerobes.