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