Discussion
tibial fracture, fracture-related infections, infection, fractures, fracture-related infection
INFECTION
In this study, we aim to definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in open tibia fractures in Tanzania. After a successful feasibility trial, we have initiated an appropriately powered randomized clinical trial [The strengths of this study include random allocation of the intervention and placebo control with masking of participants, care providers, research coordinators, outcome assessors, and the study statistician. The study results have the potential to reduce morbidity from infection after open tibial fracture using a low-cost, widely available intervention. Furthermore, results are likely to be generalizable not only to low-resource settings, but high-income countries as well.Conducting a robust clinical trial in low-income countries can pose unique operational and ethical challenges. We have previously demonstrated through both a pilot trial and previous research studies that these challenges can be largely addressed and overcome through academic partnering [In conclusion, this is a large, randomized, placebo control trial being conducted at a single center in Dar es Salaam, Tanzania, evaluating the use the local antibiotic gentamicin vs placebo (saline) for the prevention of fracture-related infection after open tibia fractures. Given the pilot study recently completed at the same center, we anticipate being able to enroll and complete the study over a period of 5 years. This study has the potential to provide definitive evidence for the use of local antibiotics as a preventative measure in open tibial fractures, a major source of musculoskeletal morbidity across the globe.