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A randomized controlled trial of perioperative rifampin/trimethoprim in cerebrospinal fluid shunt surgery
B C Walters1, L Goumnerova, H J Hoffman
1Division of Neurosurgery, Sunnybrook Health Science Centre, Toronto, Ontario, Canada.
Insights
Perioperative rifampin-trimethoprim prophylaxis showed a trend toward reducing cerebrospinal fluid (CSF) shunt infection rates, though the study was stopped early. Further research is needed to confirm its effectiveness in preventing shunt infections.
Area of Science:
- Neurosurgery
- Infectious Diseases
- Clinical Trials
Background:
- Cerebrospinal fluid (CSF) shunts are crucial for managing hydrocephalus.
- Shunt infections pose significant risks, leading to complications and further procedures.
- Preventive antibiotic strategies are essential to reduce shunt infection rates.
Purpose of the Study:
- To evaluate the efficacy of perioperative rifampin-trimethoprim as prophylaxis against CSF shunt infections.
- To compare infection rates between patients receiving antibiotics and those receiving a placebo.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 243 patients undergoing 300 CSF shunting procedures.
- Patients were stratified based on shunt insertion type (first vs. revision) and presence of meningo-myeloceles.
- Follow-up was conducted for a minimum of 2 years.
Main Results:
- The infection rate was 12% in the rifampin-trimethoprim group versus 19% in the placebo group.
- Surgical procedure infection rates were 9% for antibiotic treatment and 15% for placebo.
- The study was terminated early due to observed infection rates exceeding acceptable levels, despite not reaching statistical significance.
Conclusions:
- Perioperative rifampin-trimethoprim demonstrated a potential benefit in reducing CSF shunt infections.
- Although not statistically significant due to early termination, the trend suggested a protective effect.
- Methodological challenges in studying CSF shunt infection prevention were highlighted.
Abstract:
A randomized, double-blind, placebo-controlled trial of perioperative rifampin-trimethoprim was undertaken at the Hospital for Sick Children from March 1984 to October 1987, in which 243 patients undergoing 300 cerebrospinal fluid (CSF) shunting procedures were randomized into groups including treatment with rifampin/trimethoprim and placebo, and then followed for a minimum of 2 years. Patients were stratified prior to randomization into those with and those without meningo-myeloceles having first insertions of their shunts, and those having revisions. Patients could be entered into the study more than once, but always received the same treatment regimen once allocation had taken place. Among the patients receiving antibiotics there was an infection rate of 12%, versus 19% among patients receiving placebo. Among the surgical procedures, the rates were 9% and 15%, respectively. Because these rates of infection were a substantial increase over the rate of 7.5% overall for the few years prior to implementation of the study, and well over any acceptable rate of infection, the study was stopped before statistical significance was reached. However, had the study continued, and the proportions of patients becoming infected remained constant, we would have been able to achieve a statistically significant difference in rates of infection, and therefore demonstrate a benefit of rifampin/trimethoprim as prophylaxis against shunt infection. Methodological problems encountered in this and other studies of prevention of CSF shunt infection will be discussed.