Randomized Controlled Trial of Local Gentamicin Versus Saline to Prevent Infection in Open Tibia Fractures

What this Trial Is About

Open tibial shaft fractures, which are common serious injuries to the lower leg involving a break in the skin, often lead to infections and problems with bone healing. Researchers are evaluating the effect of locally applying the antibiotic gentamicin directly to the wound to reduce infections after these open fractures. This randomized controlled trial aims to measure whether local gentamicin can lower the risk of infection in patients with open tibial fractures in Tanzania, potentially offering a cost-effective strategy to reduce complications globally. Participants will be randomly assigned to receive either 80mg of gentamicin liquid diluted in 5 mL of saline or a placebo of 5 mL normal saline, injected directly into the fracture wound using a needle. The injection is given immediately after wound closure through an anteromedial approach at the fracture site. Both groups receive a total of 5 mL of study solution. This trial uses masking to keep participants and researchers unaware of the treatment assignment. During the study, participants will be followed for 12 months to monitor for fracture-related infections and other outcomes such as bone healing, need for unplanned surgeries, and quality of life measured by questionnaires. Clinical evaluations, imaging assessments, and questionnaires will be used to track healing and complications. Safety and health status will be closely observed throughout the study period to understand the effects of the local gentamicin treatment compared to placebo.

Gentamicin Open Tibia Study