Using vancomycin powder to prevent infections after spine surgery

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

This study is testing if using vancomycin powder during spine surgery can help prevent infections for patients undergoing this type of surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 8 sites (St. Gallen, Saint Gallen and 7 other locations)
• Trial ID: NCT04017468 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of applying suprafascial vancomycin powder during open instrumented spinal fusion surgery to reduce the incidence of surgical site infections (SSIs). Participants will be randomly assigned to receive either the vancomycin treatment or standard care without additional powder. The study aims to assess not only the rate of SSIs but also any potential complications related to vancomycin use, such as antibiotic resistance or the need for revision surgeries. The findings will help inform future larger-scale trials on this intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require open instrumented dorsal spinal fusion involving at least two adjacent vertebrae.

Not a fit: Patients with ongoing infections, known allergies to vancomycin, or those undergoing minimally invasive procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rate of surgical site infections in patients undergoing spinal fusion surgery.

How similar studies have performed: Previous retrospective studies suggest potential benefits of vancomycin in preventing SSIs, but this is one of the few well-designed prospective trials evaluating its efficacy.

Eligibility 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 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;

Where this trial is running

St. Gallen, Saint Gallen and 7 other locations

• Kantonsspital St. Gallen — St. Gallen, Saint Gallen, Switzerland (Recruiting)
• University Hostpital Bern, Department of Neurosurgery — Bern, Switzerland (Recruiting)
• University Hostpital Bern, Department of orthopaedy — Bern, Switzerland (Recruiting)
• Lindenhofspital Bern — Bern, Switzerland (Active_not_recruiting)
• Spitalzentrum Biel — Biel, Switzerland (Recruiting)
• Klinik St. Anna — Luzern, Switzerland (Recruiting)
• Schulthess Klinik — Zürich, Switzerland (Recruiting)
• University Hospital Zurich, Department of Neurosurgery — Zürich, Switzerland (Recruiting)

Study contacts

• Principal investigator: Schaer Ralph, MD — Inselspital Bern, Department of Neurosurgery
• Study coordinator: Ralph Schaer, MD

Conditions Surgical Site Infection