Clinical Trial

Gentamicin Open Tibia Study

Study acronym: GO-Tibia
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-11-30; most recent amendment 2025-04-07.
Status change: Not Yet Recruiting → Recruiting 2022-09-02
Trial Details
NCT Number NCT05157126
Lead Sponsor University of California, San Francisco
Collaborators: Muhimbili Orthopaedic Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Orthopedic Research and Education Foundation
Conditions Fracture Open Tibia
Enrollment 890 participants
Start Date 2022-09-01
Primary Completion 2028-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2025-04-10