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Efficacy of Intrawound Vancomycin in Spine Surgery
Sponsor: Ain Shams University
Summary
"This multicenter, prospective, time-cluster randomized controlled trial with blinded endpoint assessment (PROBE design) 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 blinded clinical assessors to minimize bias."
Official title: Title: Efficacy of Intrawound Vancomycin Powder in Reducing Surgical Site Infections in Spine Surgery: A Multicenter, Time-Cluster Randomized Controlled Trial With Blinded Endpoint Assessment
Key Details
Gender
All
Age Range
15 Years - 78 Years
Study Type
INTERVENTIONAL
Enrollment
416
Start Date
2023-12-02
Completion Date
2026-06-02
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
vancomycin
Application of 2 grams of intrawound vancomycin powder topically to the deep and subfascial layers prior to wound closure.
Standard surgical closure
Standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics.
Locations (1)
Ain Shams University Hospitals.
Cairo, Egypt