Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

This pilot study is being conducted in Dar es Salaam, Tanzania to assess the feasibility of a masked, placebo‐controlled, randomized trial to compare local gentamicin injection to saline injection in open tibial shaft fractures. The study will enroll patients within 1 week of injury. The active or placebo agent will be administered during the initial surgical debridement based on a web‐based randomization tool. Patients will be followed for 1 year after surgery to assess for the occurrence of fracture‐related infection (FRI), a consensus definition of infection after open fracture or insertion of internal fixation to treat fracture. Additional clinical and economic endpoints will also be measured. Depending on the outcome of the feasibility study, we may undertake a definitive trial to test the effectiveness of local gentamicin to prevent FRI. If proven effective, local gentamicin would impact the clinical care of open fracture patients both in Tanzania and likely in high‐income settings as well. These data will also deepen the understanding of the clinical and economic impact of FRI in open fracture populations.