CompletedPhase 2

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

Switzerland450 participantsStarted 2019-10-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: within 90 days following index surgery

Trial details

NCT IDNCT04017468

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-10

View on ClinicalTrials.gov More Surgical Site Infection trials