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New rinse aims to cut infection risk in spine surgery

NCT ID NCT07667036

Prevention Sponsor: Universität Luzern 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study tests whether rinsing the surgical wound with a solution called PREVENTIA (polyhexanide and poloxamer) during spinal fusion surgery can reduce bacteria in the wound. About 114 adults having elective spine surgery will be randomly assigned to receive either the special rinse or a standard saltwater rinse. The main goal is to see if the special rinse lowers the number of bacteria found on swabs taken during the operation.

What this could mean

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

Active substance
Polyhexanide-poloxamer solution (PREVENTIA)
What this could lead to
If it works, this could provide a simple way to lower infection risk in spine surgeries, reducing complications and recovery time.
What could go wrong
This is a small, early-phase trial (114 people) testing only bacterial reduction, not actual infection rates. The rinse may not prevent infections in practice, and results may not apply to all spine surgeries.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 114 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 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

Male participants only

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 more than 18 years * Plan to undergo elective spinal fusion surgery (including thoracic and lumbar vertebrae, and sacrum and coccyx) * Informed consent as documented by signature Exclusion Criteria: * Emergency spine surgery * Previous spine fusion surgery * Unable to follow the comply with the study procedure or provide informed consent * Known allergies to any of the products used in the trial * Female gender * Current or recent (last 14 days) antibiotic therapy * Participation in another trial with an antimicrobial substance within the 30 days preceding and during the present trial * Known or suspected drug or alcohol abuse * Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject * Evidence or suspicion of preexisting infection, defined as: Current local infection (or active treatment) involving the spine or adjacent soft tissues (e.g. spondylodiscitis, epidural or paravertebral abscess, cellulitis at the intervention site) diagnosed clinically or by imaging prior to intervention; Active systemic bacterial/fungal infection requiring antimicrobial therapy

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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.

Spine surgery Surgical site infection (SSI) Surgical site infection prevention

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

  • Hirslanden Klinik St. Anna

    Lucerne, 6006, Switzerland

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