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New decolonization method could lower infection risk in spine surgery

NCT ID NCT06633588

Disease control Sponsor: Swiss Paraplegic Research, Nottwil Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This pilot study compares a new decolonization regimen using polyhexanide (nasal gel and body foam) to the standard mupirocin and chlorhexidine treatment for reducing Staphylococcus aureus bacteria before elective spine surgery. The trial includes 24 adults who carry Staph bacteria and are scheduled for spine surgery. The goal is to see if the new approach is feasible, tolerable, and effective at lowering bacterial levels to potentially prevent surgical infections.

What this could mean

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

Active substance
polyhexanide (nasal gel and body foam)
What this could lead to
If effective, this could offer an alternative decolonization method to reduce infection risk before spine surgery.
What could go wrong
This is a small pilot study with only 24 participants, so results may not be conclusive. The new regimen might not work as well as the standard treatment.

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

24 people

The number who actually took part.

Started

May 2025

Finished

Jun 2026

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 over 18 years * Scheduled for elective spinal surgery * Colonized with Staphylococcus aureus * Informed consent provided Exclusion Criteria: * Emergency spine surgery * Methicillin-resistant Staphylococcus aureus (MRSA) or mupirocin-resistant S. aureus * Known allergies to products used in the trial * Pregnant or breastfeeding women * Recent antibiotic therapy (within 14 days) * Known non-compliance, substance abuse, or psychological disorders * Participation in another antimicrobial trial within the last 30 days

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Conditions

The condition(s) this trial relates to.

Asymptomatic Infections staphylococcal infection staphylococcus aureus infection

As listed by the trial registrant

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

Colonization, asymptomatic Staphylococcus aureus

Contacts and locations

Locations

  • Swiss Paraplegic Centre

    Nottwil, Canton of Lucerne, 6207, Switzerland

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