A prospective, randomized, double-blind studyof single high dose versus multiple standard dose gentamicin both in combination withmetronidazole for colorectal surgicalprophylaxis.
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.
Zelenitsky
S A
SA
Departments of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada. zelenits@ms.umanitoba.ca
Silverman
R E
RE
Duckworth
H
H
Harding
G K
GK
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*
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D005839:Gentamicins; D008795:Metronidazole