drugset / Trial / NCT07866157

Efficacy of Intrawound Vancomycin in Spine Surgery

NCT07866157 ↗

Phase 3 Completed 416 enrolled Ain Shams University
Non-randomizedParallel-groupSingle-blindPrevention

Summary

This prospective, quasi-randomized, comparative study evaluated the efficacy of intrawound vancomycin powder (2 g) in preventing surgical site infections (SSI) following spine surgeries. The study included 416 patients who were allocated using alternating monthly time-clusters (25 months) to receive either standard care with topical vancomycin or standard care alone (control). The primary endpoint, the incidence of 90-day SSI, was evaluated by a blinded assessor to minimize bias.

Timeline

Start
2023-12-02
Primary completion
2026-05-02
Completion
2026-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 2 g Topical