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

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: University Hospital Freiburg
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age requiring open instrumented dorsal spinal fusion of at least 1 level (involving two adjacent vertebras and one intervertebral disc)

• Signed informed consent

Exclusion Criteria:

• Preoperative ongoing infectious disease present as judged by primary surgeon (based on lab results and clinical assessment);

• Previous spine surgery at index level within last 90 days;

• Known allergy to vancomycin;

• Percutaneous or transmuscular instrumentation (minimally-invasive surgery) only without lumbar interbody fusion;

• Postoperative radiotherapy of surgical site required (e.g. for tumor)

• Preexisting cochlea damage OR known history of hearing loss;

• Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse;

• Pregnancy or breastfeeding women;

• Participation in other ongoing clinical trials;

• Patients lacking capacity to consent;