drugset / Trial / NCT04017468

Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion

NCT04017468

RandomizedParallel-groupSingle-blindPrevention

Summary

Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs In this randomized controlled trial the investigators aim to prospectively investigate the efficacy and safety of suprafascial intrawound vancomycin powder in reducing the rate of SSIs after instrumented spinal fusion surgery. Secondary aims of the study are the incidence of vancomycin-related complications, vancomycin-resistant bacterial infections in the treatment arm as well as the rate of revision surgeries due to SSIs.

Timeline

Start
2019-10-15
Primary completion
2026-09-30
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vancomycin Other / unclassified 1 g Subcutaneous
Comparator Vancomycin Other / unclassified 2 g Subcutaneous

Indications

No indication recorded.