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RECRUITING Phase 4 ClinicalTrials.gov

Gentamicin Open Tibia Study

Sponsor: University of California, San Francisco • ClinicalTrials.gov ID: NCT05157126

Registry updated: 2026-09-10
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Description

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.

Interventions

  • Gentamicin (Drug)
    Liquid gentamicin administered at the open fracture site
  • normal Saline (Drug)
    Normal saline administered at the open fracture site

Eligibility criteria

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

Conditions

Fracture Open Tibia

Locations

  • Muhimbili Orthopaedic Institute — Dar es Salaam, Tanzania
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record