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

Phase 3

Recruiting

• Conditions: Infection
• Interventions: Drug: Vancomycin

• Registration Number: NCT05959603
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-31
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-07-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: 500 mg vancomycin	Vancomycin	Patients will receive 500 mg of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis
Intervention group: 1 g vancomycin	Vancomycin	Patients will receive one gram of powdered vancomycin to the surgical site in addition to standard of care IV prophylaxis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum vancomycin levels	6 and 12 hours post op and then one test a day until vancomycin levels reach zero	Serum vancomycin levels
Incidence of superficial spinal infections	One year	According to CDC criteria
Individual components of the composite primary outcomes	One year	Deep surgical site infections and superficial surgical site infections separately
Rate of Surgical site infection revisions	30 days	Number of surgical site infection revisions
Number of adverse events	Up to one week post-surgery	Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity
Length of hospitalization	From operation date to discharge (up to 4 weeks) or date of death	Length of hospitalization starting on operation date up to discharge or death
Rate of mortality	One year	Rate of mortality among study participants within one year from operation date
Rate of post-operative seroma	30 days	Rate of post-operative seroma
Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)	Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30	Creatinine, glucose and albumin lab results

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel