Antibiotic powder on broken legs: can it stop deadly infections?
NCT ID NCT05157126
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Open tibia fractures break the skin and expose bone, which lets bacteria in and leads to infections that can cause disability. Researchers in Tanzania are testing whether applying the antibiotic gentamicin directly to the wound during surgery prevents infection better than saline. The trial enrolls adults with these fractures and compares infection rates over the following year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gentamicin, an antibiotic applied directly to the open fracture wound
- What this could lead to
- If local gentamicin lowers infection risk, it could become a cheap, widely usable way to prevent complications from open tibia fractures in both low- and high-income countries.
- What could go wrong
- Open fractures are contaminated and complex, so a single antibiotic applied at the wound may not prevent all infections. The trial runs in one country, and results may not apply everywhere.
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 890 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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Apr 2029
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 old * Open tibial shaft fracture meeting the following criteria: 1. Orthopaed Trauma Association (OTA) Type 42 2. Primarily closable wound 3. Gustilo-Anderson (GA) Type I, II, or IIIA Exclusion Criteria: * Time from injury to presentation \> 48 hours * Time from injury to surgery \> 7 days * Aminoglycoside allergy * GA IIIB or IIIC open fractures * Bilateral open tibial fractures * Severe brain (GCS\<12) or spinal cord injury * Severe vascular injury * Severe burns (\>10% Total Body Surface Area (TBSA) or \>5% TBSA with full thickness or circumferential injury) * Pathologic fracture * History of active limb infection, ipsilaterally * Unlikely to complete follow-up
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Muhimbili Orthopaedic Institute
RECRUITINGDar es Salaam, Tanzania