drugset / Trial / NCT04017468
Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Phase 2
Active not recruiting
450 enrolled
Insel Gruppe AG, University Hospital Bern
University Hospital Freiburg · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs In this randomized controlled trial the investigators aim to prospectively investigate the efficacy and safety of suprafascial intrawound vancomycin powder in reducing the rate of SSIs after instrumented spinal fusion surgery. Secondary aims of the study are the incidence of vancomycin-related complications, vancomycin-resistant bacterial infections in the treatment arm as well as the rate of revision surgeries due to SSIs.
Timeline
- Start
- 2019-10-15
- Primary completion
- 2026-09-30
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vancomycin | Other / unclassified | 1 g | Subcutaneous |
| Comparator | Vancomycin | Other / unclassified | 2 g | Subcutaneous |
Indications
No indication recorded.