Randomized clinical trial of intra-operative antimicrobial prophylaxis of infection after neurosurgical procedures

J Hosp Infect. 1986 Nov;8(3):283-95. doi: 10.1016/0195-6701(86)90125-8.

Abstract

A randomized, placebo-controlled, double-blind and sequentially analysed clinical trial to determine the efficacy of intra-operative parenteral gentamicin and vancomycin (with streptomycin in the irrigating solution) in preventing infection at the operative site following neurosurgical procedures is described. Patients receiving prophylaxis had a significantly (P = 0.046) lower operative site infection rate (2/71 = 2.8%) than those receiving placebo (9/77 = 11.7%). This difference was most apparent during an epidemic, the source of which was not evident. Moreover, a total of 13 infections (two operative site, five pneumonia and six urinary tract) occurred among 12 patients receiving prophylaxis, whereas there was a total of 31 infections (nine operative site, nine pneumonia, 10 urinary tract and three septicaemia) among 24 patients receiving placebo. A smaller quantity of antimicrobial drugs was administered postoperatively to patients receiving prophylaxis (3.96 'antibiotic-days' per patient) than to those receiving placebo (6.87 'antibiotic-days' per patient).

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Anti-Bacterial Agents / therapeutic use*
  • Bacterial Infections / prevention & control*
  • Cerebrospinal Fluid Shunts
  • Clinical Trials as Topic
  • Double-Blind Method
  • Female
  • Gentamicins / therapeutic use
  • Humans
  • Intraoperative Period
  • Male
  • Meningitis / prevention & control
  • Neurosurgery*
  • Pneumonia / prevention & control
  • Postoperative Complications / prevention & control*
  • Random Allocation
  • Sepsis / prevention & control
  • Surgical Wound Infection / prevention & control
  • Urinary Tract Infections / prevention & control
  • Vancomycin / therapeutic use

Substances

  • Anti-Bacterial Agents
  • Gentamicins
  • Vancomycin