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Gentamicin Open Tibia Study

RecruitingPhase 4Ages 18 Years - anyAllUniversity of California, San Francisco
NCT05157126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This study aims to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

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📋 Eligibility rules (as published)
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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What it tests

  • Gentamicin
  • normal Saline
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Where

1 site
Muhimbili Orthopaedic Institute
Dar es Salaam, Tanzania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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