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

NCT05959603 · tracked via the Priya Life Science Israel tracker

Sponsor

Rabin Medical Center

Phase

Phase 3

Started

2020-05-31

Last updated

2024-11-27

Condition(s) studied

Infection

Investigational drug(s) / intervention(s)

Vancomycin →

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center * Ability to understand and sign written informed consent by the patient or legal guardian Exclusion Criteria: * Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment) * Receiving ongoing treatment of antibiotics for other infections * Sensitivity or allergy to vancomycin or cefazolin * Previous spine surgery at the index level within the last 90 days * Postoperative radiotherapy of the surgical site required (e.g. for tumor) * Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse * Undergoing spinal decompression only * Trauma patients * Pregnancy

Primary outcome measure(s)

Incidence of deep spinal infections — One year
According to Center for Disease Control and Prevention (CDC) criteria

Trial sites (1)

Facility	City	Region	Status
Rabin Medical Center	Petah Tikva	Israel	Recruiting

On this site

📄 Vancocin (vancomycin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05959603 on ClinicalTrials.gov ↗ ← All trials in Israel