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RECRUITING
NCT05157126
PHASE4

Gentamicin Open Tibia Study

Sponsor: University of California, San Francisco

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.

Official title: A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

890

Start Date

2022-09-01

Completion Date

2029-04

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

DRUG

Gentamicin

Liquid gentamicin administered at the open fracture site

DRUG

normal Saline

Normal saline administered at the open fracture site

Locations (1)

Muhimbili Orthopaedic Institute

Dar es Salaam, Tanzania