title: A prospective, randomized, double-blind studyof single high dose versus multiple standard dose gentamicin both in combination withmetronidazole for colorectal surgicalprophylaxis.
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.
authors.affiliation: Departments of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada. zelenits@ms.umanitoba.ca
authors.forename: S A
authors.initials: SA
authors.lastname: Zelenitsky
authors.forename: R E
authors.initials: RE
authors.lastname: Silverman
authors.forename: H
authors.initials: H
authors.lastname: Duckworth
authors.forename: G K
authors.initials: GK
authors.lastname: Harding
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D015179:Colorectal Neoplasms / Q000601:surgery*; D048909:Diabetes Complications; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000008:administration & dosage*; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D017053:Infection Control / Q000379:methods*; D015212:Inflammatory Bowel Diseases / Q000601:surgery*; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D014946:Wound Infection / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D005839:Gentamicins; D008795:Metronidazole