Nose swab could stop staph infections after broken leg surgery
NCT ID NCT05763602
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University
Atlanta, Georgia, 30303, United States
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University of Indiana
Indianapolis, Indiana, 46202, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Texas Southwestern
Dallas, Texas, 75235, United States
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University of Utah
Salt Lake City, Utah, 84108, United States
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Washington University
St Louis, Missouri, 63110, United States
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