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

NCT04017468 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

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.

Sponsors & Collaborators

  • University Hospital Freiburg

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Schaer Ralph, MD · Inselspital Bern, Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017468 on ClinicalTrials.gov