Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery
Recruiting
Phase 3
Interventional Study
Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 363 (estimated)
- Sponsor
- Rabin Medical Center · Other
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About This Trial
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 V…
Trial Locations
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Eligibility 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 a…
Contacts