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
Sponsor study identifier
interventional
416
1 country
1
Study Start
December 2, 2023
Actual (reported)Primary Completion
May 2, 2026
Actual (reported)Study Completion
June 2, 2026
Actual (reported)"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."
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2023
Actual (reported)May 2, 2026
Actual (reported)June 2, 2026
Actual (reported)October 4, 2026
Actual (reported)October 8, 2026
Actual (reported)INCIDENCE OF SURGICAL SITE INFECTION (SSI)
The primary outcome is the occurrence of any superficial, deep, or organ/space surgical site infection (SSI) following the index spine surgery. SSI is diagnosed and classified according to the standard criteria set by the Centers for Disease Control and Prevention (CDC).
UP TO 90 DAYS
Depth of Surgical Site Infection (SSI)
UP TO 90 DAYS
Microbiological Profile of Surgical Site Infections
Up to 90 days post-operatively
Patients operated on during the intervention time-clusters received 2 grams of intrawound vancomycin powder applied topically to the deep and subfascial layers prior to wound closure.
Patients operated on during the control time-clusters received standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics.
Application of 2 grams of intrawound vancomycin powder topically to the deep and subfascial layers prior to wound closure.
Standard surgical site preparation and standard wound closure without the application of topical intrawound antibiotics.
Ain Shams University Hospitals.
Cairo, 11511, Egypt
416 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2026
First Posted
October 8, 2026
Study Start
December 2, 2023
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2, 2026
Actual (reported)Study Completion
June 2, 2026
Actual (reported)Last Updated
October 15, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: