Using Vancomycin Powder to Prevent Infections After Spinal Surgery
Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial
This study is testing if adding Vancomycin powder to standard antibiotics can help prevent infections after spinal surgery for patients undergoing posterior spinal fusion.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 363 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT05959603 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of standard antibiotic treatment with the addition of intra-wound Vancomycin powder in preventing surgical site infections following spinal surgery. Patients undergoing posterior spinal fusion at the Rabin Medical Center will be enrolled and receive either the standard treatment or the additional Vancomycin. The study aims to identify the optimal dosage of Vancomycin while all participants will also receive routine intravenous antibiotic prophylaxis. The goal is to determine if the use of Vancomycin can significantly reduce wound-related complications.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for posterior spinal fusion surgery at the Rabin Medical Center who can provide informed consent.
Not a fit: Patients with ongoing infections, severe renal insufficiency, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rates of surgical site infections, improving recovery outcomes for patients undergoing spinal surgery.
How similar studies have performed: Other studies have shown promising results with the use of topical antibiotics in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Petah Tikva
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Eyal Itshayek, MD — Rabin Medical Center
- Study coordinator: Eyal Itshayek, MD
- Email: eyal.itshayek@gmail.com
- Phone: +972-50-8946921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.