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A new wash could outsmart spine surgery infections without the seroma risk

NCT ID NCT06439953

Disease control Sponsor: Rhode Island Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Aug 14, 2026

Summary

This trial compares two ways to clean the wound during spinal instrumentation surgery to prevent surgical site infections. One method uses Irrisept, a chlorhexidine-based antiseptic rinse, while the other uses a vancomycin-saline wash, sometimes with added vancomycin powder. The study includes adults undergoing spine surgery for deformity, tumors, degeneration, or trauma, and tracks infection rates, hospital stay length, readmissions, and mortality. The goal is to see if Irrisept can lower infection risk while avoiding the fluid buildup (seroma) that topical vancomycin powder may cause.

What this could mean

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

Active substance
Irrisept (chlorhexidine gluconate solution) irrigation compared with vancomycin-saline irrigation, with or without topical vancomycin powder
What this could lead to
If Irrisept works better, it could reduce deep spine infections after surgery and avoid the seroma risk linked to topical vancomycin powder.
What could go wrong
This is a single-center trial with 200 patients, so results may not apply broadly. Irrisept may not outperform vancomycin, and any irrigation method carries risks like allergic reactions or tissue irritation.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

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: * Age: 18+ years old * Indications: deformity, oncologic, degenerative, trauma * Standard layer-by-layer closure * Locoregional flap-based closure Exclusion Criteria: * Acute/chronic open wounds (spine or non-spine) * On-going non-spinal infection within 30 days of index operation * Concurrent antibiotic use (for spine or non-spine infections) * History of prior spinal infection * Allergy to vancomycin or chlorhexidine * Suspicion for osteomyelitis * Other surgery within 90 days post-operatively fromm index * Concurrent enrollment in other trial

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Conditions

The condition(s) this trial relates to.

Postoperative Complications Surgical Wound Infection

As listed by the trial registrant

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

Index spinal instrumentation Layer-by-layer closure Locoregional flap-based closure Post-op complication Site infection Spinal instrumentation Spine surgery Surgical site infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.