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NCT05157126
Gentamicin Open Tibia Study
Conditions: Fracture Open Tibia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 890
Sponsor: University of California, San Francisco
Location: Muhimbili Orthopaedic Institute Dar es Salaam
Summary
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.
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\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
Source: ClinicalTrials.gov (NCT05157126). StuddyBuddy aggregates publicly available trial information.