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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05157126). StuddyBuddy aggregates publicly available trial information.