drugset / Trial / NCT03559400

Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

NCT03559400

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

EvaluationDrugModalityDoseRoute
Subject Gentamicin Small molecule 80 mg Other

Indications

No indication recorded.