Status:
ACTIVE_NOT_RECRUITING
Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University Hospital Freiburg
Conditions:
Surgical Site Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
Background: Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs. Numerous retrospective studies suggest the us...
Eligibility Criteria
Inclusion
- 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
- 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 NOT clearly associated with age-related hearing impairment (presbycusis);
- 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;
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04017468
Start Date
October 15 2019
End Date
March 31 2027
Last Update
July 9 2025
Active Locations (7)
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1
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
2
University Hostpital Bern, Department of Neurosurgery
Bern, Switzerland, 3010
3
University Hostpital Bern, Department of orthopaedy
Bern, Switzerland, 3010
4
Lindenhofspital Bern
Bern, Switzerland, 3012