NCT05959603

Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery

Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.

Conditions

• Infection

Interventions

Type	Name	Description
DRUG	Vancomycin	Powdered vancomycin will be locally administered once during surgery. The vancomycin will be placed in the surgical bed at several layers: around the hardware and before muscle apposition and above the fascia. This is done before the closure of the muscular fascia and skin by the neurosurgeon. The vancomycin will not be mixed in the bone graft.

Timeline

• Start date: 2020-05-31
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-07-25
• Last updated: 2024-11-27

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study