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ACTIVE NOT RECRUITING
NCT04017468
PHASE2

Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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

Interventions

DRUG

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