Multicenter prospective randomized phase II study of antimicrobial prophylaxis in low-risk patients undergoing colon surgery

Surg Today. 2010 Oct;40(10):954-7. doi: 10.1007/s00595-009-4176-5. Epub 2010 Sep 25.

Abstract

Purpose: Postoperative antimicrobial therapy is generally administered as standard prophylaxis against postoperative infection, despite a lack of sufficient evidence for its usefulness. This study was a phase II study to evaluate the necessity of postoperative antibiotic prophylaxis in patients undergoing a colectomy.

Methods: Patients received 1 g cefmetazole or flomoxef immediately after anesthetic induction, every 3 h during surgery, and then later once again on the next day. They were randomly assigned to receive either cefmetazole or flomoxef.

Results: Ninety-one patients were enrolled in the study. A surgical site infection (SSI) occurred in 7.7% (7/91) of patients. All cases were superficial incisional infections. When comparing the two drugs, SSI occurred in 8.3% (4/48) of patients treated with cefmetazole and in 7.0% (3/43) treated with flomoxef, showing no significant difference (P > 0.99).

Conclusion: Antimicrobial prophylaxis was well tolerated when used on the day of a colectomy and once again on the next day.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / administration & dosage*
  • Antibiotic Prophylaxis / methods*
  • Cefmetazole / administration & dosage*
  • Cephalosporins / administration & dosage*
  • Colectomy*
  • Colonic Diseases / surgery
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Surgical Wound Infection / epidemiology
  • Surgical Wound Infection / prevention & control*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Cephalosporins
  • Cefmetazole
  • flomoxef