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NCT Number: NCT05959603

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

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.

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Key information

Conditions

Infection Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rabin Medical Center

Petah Tikva, Israel

Location status: Recruiting

Location contact

Belaynesh Keren Melke, BSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

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.

Primary outcomes

  1. Incidence of deep spinal infections

    Time frame: One year

    According to Center for Disease Control and Prevention (CDC) criteria

Secondary outcomes

  1. Incidence of superficial spinal infections

    Time frame: One year

    According to CDC criteria

  2. Individual components of the composite primary outcomes

    Time frame: One year

    Deep surgical site infections and superficial surgical site infections separately

  3. Rate of Surgical site infection revisions

    Time frame: 30 days

    Number of surgical site infection revisions

  4. Number of adverse events

    Time frame: Up to one week post-surgery

    Number of adverse events Including rash, acute kidney injury (according to RIFLE criteria, see appendix), ototoxicity

  5. Length of hospitalization

    Time frame: 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

  6. Rate of mortality

    Time frame: One year

    Rate of mortality among study participants within one year from operation date

  7. Rate of post-operative seroma

    Time frame: 30 days

    Rate of post-operative seroma

  8. Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl)

    Time frame: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30

    Creatinine, glucose and albumin lab results

  9. Serum vancomycin levels

    Time frame: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero

    Serum vancomycin levels

Study contacts

Contact information is provided by the study sponsor or research team.

Eyal Itshayek, MD

CONTACT

[email protected]

+972-50-8946921

Shani Berkowitz, Msc

CONTACT

[email protected]

+972528620737

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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