drugset / Trial / NCT05157126
Gentamicin Open Tibia Study
Phase 4
Recruiting
890 enrolled
University of California, San Francisco
Muhimbili Orthopaedic Institute · collabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collabOrthopedic Research and Education Foundation · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2022-09-01
- Primary completion
- 2028-04
- Completion
- 2029-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gentamicin | Small molecule | 80 mg | Other |
Indications
No indication recorded.