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Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Sponsor: Insel Gruppe AG, University Hospital Bern
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2019-10-15
Completion Date
2027-03-31
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Interventions
Vancomycin
Patients randomized into the treatment arm will receive 1-2 g of vancomycin powder (Vancocin® i.v.) which will be administered above the closed muscle fascia (suprafascially) before closing the subcutaneous tissue and skin. The dose of the drug will depend on the length of the skin incision: 1 g for incisions ≤ 20 cm, 2 g for incisions ≥ 20 cm.
Locations (7)
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hostpital Bern, Department of Neurosurgery
Bern, Switzerland
University Hostpital Bern, Department of orthopaedy
Bern, Switzerland
Lindenhofspital Bern
Bern, Switzerland
Spitalzentrum Biel
Biel, Switzerland
Klinik St. Anna
Lucerne, Switzerland
University Hospital Zurich, Department of Neurosurgery
Zurich, Switzerland