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Nose swab could stop staph infections after broken leg surgery

NCT ID NCT05763602

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether putting povidone iodine ointment inside the nose before surgery can lower the risk of surgical site infections, especially from staph bacteria, in people having surgery for severe leg, ankle, or foot fractures. About 2000 adults will receive the nose treatment before their operation. The goal is to see if this simple step reduces deep infections and helps patients heal better.

What this could mean

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

Active substance
povidone iodine ointment applied inside the nose
What this could lead to
If it works, this simple, low-cost nose treatment could become a standard way to prevent serious infections after leg fracture surgery.
What could go wrong
This is a single trial with 2000 participants, and results may not apply to all surgeries or patients. The treatment might not reduce infections enough to be worthwhile.

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 2,000 people

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

Started

Sep 2022

Expected to finish

May 2026

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 of age. * Is undergoing one or more procedures to address the included fractures listed below for one or more (at least one) HELEF at high-risk for SSI: * Open tibia fractures * Open femur fractures * Open or closed tibial plateau fractures * Open or closed tibial pilon fractures * Open or closed calcaneus fractures * Open or closed talus fractures * Open or closed foot fractures of any bone EXCEPT the toes * Open fibula fractures * Open rotational ankle fractures (malleoli) * Open or closed leg fractures associated with compartment syndrome * Examples of included procedures: * Excisional debridement of open fracture, femur and/or tibia * Intramedullary nail, tibia (open injury) * Intramedullary nail, femur (open injury) * Open reduction Pilon/Plafond fracture * Open reduction tibial plateau fracture * Open reduction calcaneal fracture * Open reduction Lisfranc/metatarsal associated with crush injury * Open reduction talus * External fixation, lower extremity tibia or femur associated with open fracture or compartment syndrome * Fasciotomy, lower extremity for compartment syndrome related to femur, tibia, or foot fracture * Lower extremity amputation related to HELEF Exclusion Criteria: * Documented or verbalized sensitivity or allergy to iodine or iodine-based contrast. * Known pregnancy in women. * Active bacterial infection at the HELEF site. * Incarcerated persons. * Persons who cannot follow up at the participating site (e.g., people who are homeless at the time of the injury or people with intellectual challenges who lack the social support for follow up visits). * Patients with facial fractures or other conditions that preclude nasal swabbing. * Patients who do not speak English or Spanish.

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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.

Contacts and locations

Locations

  • Emory University

    Atlanta, Georgia, 30303, United States

  • University of Indiana

    Indianapolis, Indiana, 46202, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Texas Southwestern

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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