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Can a sprinkle of antibiotic powder stop spine surgery infections?

NCT ID NCT04017468

Prevention Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether placing vancomycin powder under the skin before closing a spinal fusion incision can reduce surgical site infections, which occur in up to 12% of such surgeries. Adults undergoing open spinal fusion will be randomly assigned to receive either the standard care or the antibiotic powder. The study will track infection rates, complications, and the need for follow-up surgeries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vancomycin powder applied above the muscle layer before wound closure
What this could lead to
If effective, this simple, low-cost approach could significantly reduce painful and costly infections after spinal fusion surgery, improving recovery and reducing hospital stays.
What could go wrong
This is a Phase 2 trial, so results are uncertain. Risks include potential allergic reactions, development of vancomycin-resistant bacteria, or no significant benefit over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

450 people

The number who actually took part.

Started

Oct 2019

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Surgical site infection

Contacts and locations

Locations

  • Kantonsspital St. Gallen

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

  • Klinik St. Anna

    Lucerne, 6006, Switzerland

  • Lindenhofspital Bern

    Bern, 3012, Switzerland

  • Spitalzentrum Biel

    Biel, 2501, Switzerland

  • University Hospital Zurich, Department of Neurosurgery

    Zurich, 8091, Switzerland

  • University Hostpital Bern, Department of Neurosurgery

    Bern, 3010, Switzerland

  • University Hostpital Bern, Department of orthopaedy

    Bern, 3010, Switzerland

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