drugset / Trial / NCT03559400
Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania
Completed
100 enrolled
University of California, San Francisco
Muhimbili Orthopaedic Institute · collabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial 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
- 2019-11-19
- Primary completion
- 2021-09-15
- Completion
- 2021-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gentamicin | Small molecule | 80 mg | Other |
Indications
No indication recorded.