Actively Recruiting

Phase 3
Age: 18Years - 90Years
All Genders
NCT05959603

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

Led by Rabin Medical Center · Updated on 2024-11-27

363

Participants Needed

1

Research Sites

339 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Preoperative ongoing infectious disease as judged by the primary surgeon
  • Receiving ongoing antibiotic treatment for other infections
  • Allergy or sensitivity to vancomycin or cefazolin
  • Previous spine surgery at the same level within the last 90 days
  • Need for postoperative radiotherapy at the surgical site
  • Stage 4 chronic kidney disease with glomerular filtration rate 15-30 ml/min or worse
  • Undergoing spinal decompression only
  • Trauma patients
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Rabin Medical Center

Petah Tikva, Israel

Actively Recruiting

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Research Team

E

Eyal Itshayek, MD

CONTACT

S

Shani Berkowitz, Msc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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