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

NCT04017468 | Active Not Recruiting Phase 2

• 1 other identifier: 2019-01143
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 7

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 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

Outcome Measures

Primary Outcomes (1)

• Rate of superficial and deep SSIs (according to CDC criteria)

  within 90 days following index surgery

Secondary Outcomes (11)

• Rate of revision surgery due to SSIs

  within 90 days following index surgery

• Rate of vancomycin-resistant bacterial infections in the treatment group

  within 90 days following index surgery

• Rate of vancomycin-related adverse events both locally and systemically

  within 90 days following index surgery

• Rate of wound healing disorders without SSI within

  within 90 days following index surgery

• Rate of wound seromas

  within 90 days following index surgery

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

The powdered vancomycin will be placed subcutaneously over the closed muscle fascia (suprafascially) at the end of the surgery during wound closure.

Drug: Vancomycin

Control Arm

NO INTERVENTION

The control group receiving only a standard preoperative antimicrobial prophylaxis administered intravenously.

Interventions

Vancomycin DRUG

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital Freiburg: collaborator

Study Sites (7)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

University Hostpital Bern, Department of Neurosurgery

Bern, 3010, Switzerland

Location

University Hostpital Bern, Department of orthopaedy

Bern, 3010, Switzerland

Location

Lindenhofspital Bern

Bern, 3012, Switzerland

Location

Spitalzentrum Biel

Biel, 2501, Switzerland

Location

Klinik St. Anna

Lucerne, 6006, Switzerland

Location

University Hospital Zurich, Department of Neurosurgery

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Schar RT, Branca M, Fischer U, Zimmerli S, Soll N. Intrawound vancomycin powder for prevention of surgical site infections after open instrumented posterior spinal fusion (VANCO Trial)-methodology of a randomized, controlled, multicenter study. Trials. 2025 Sep 24;26(1):344. doi: 10.1186/s13063-025-09095-z.

  PMID: 40993807 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Schaer Ralph, MD

  Inselspital Bern, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: October 15, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (7)