Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07866157
PHASE3

Efficacy of Intrawound Vancomycin in Spine Surgery

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Official title: Efficacy of Intrawound Vancomycin Powder in Preventing Surgical Site Infections in Spine Surgery: A Prospective, Quasi-Randomized Comparative Study

Key Details

Gender

All

Age Range

18 Years - 78 Years

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2023-12-02

Completion Date

2026-06-02

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DRUG

vancomycin

Application of 2 grams of intrawound vancomycin powder topically to the deep and subfascial layers prior to wound closure.

PROCEDURE

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