A prospective, randomized, double-blind studyof single high dose versus multiple standard dose gentamicin both in combination withmetronidazole for colorectal surgicalprophylaxis

J Hosp Infect. 2000 Oct;46(2):135-40. doi: 10.1053/jhin.2000.0814.

Abstract

Single, high dose regimens of gentamicin plus metronidazole for colorectal surgical prophylaxis have not been adequately studied. Patients received single high dose gentamicin (4.5 mg/kg) plus metroni-dazole (500 mg) preoperatively or multiple standard dose gentamicin (1.5 mg/kg) plus metronidazole (500 mg) preoperatively and every 8h for 24h postoperatively. The deep surgical site infection (SSI) rates were 8.1% (6/74) and 6.9% (5/72) in the single high dose and multiple standard dose groups, respectively (P= 0.94). There was a trend towards fewer superficial SSIs in the single high dose group with infection rates of 18.9% (14/74) vs. 30.6% (22/72) (P= 0.05). Diabetes mellitus (odds ratio = 7.04) and surgery duration of longer than 3h (odds ratio = 5.46) were independent risk factors for the development of SSIs. A subset analysis of prolonged operations found significantly fewer superficial SSIs in the single high dose group than in the multiple standard dose group with rates of 22.2% (6/27) vs. 55% (11/20), respectively (P= 0.021). Single high dose gentamicin plus metronidazole preoperatively was at least as effective as the multiple standard dose regimen and may be more effective for prolonged operations.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / pharmacokinetics
  • Anti-Infective Agents / administration & dosage*
  • Antibiotic Prophylaxis / methods*
  • Colorectal Neoplasms / surgery*
  • Diabetes Complications
  • Double-Blind Method
  • Drug Therapy, Combination / administration & dosage*
  • Female
  • Gentamicins / administration & dosage*
  • Gentamicins / pharmacokinetics
  • Humans
  • Infection Control / methods*
  • Inflammatory Bowel Diseases / surgery*
  • Male
  • Metronidazole / administration & dosage*
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Time Factors
  • Wound Infection / epidemiology
  • Wound Infection / etiology*
  • Wound Infection / prevention & control*

Substances

  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Gentamicins
  • Metronidazole