A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia)

Abstract

Background:Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture.Methods:This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection.Results:Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Complete data were recorded at baseline and follow-up for >95% of cases. The rate of follow-up at 6 weeks, 3 months, 6 months, 9 months, and 1 year were 70%, 68%, 69%, 61%, and 80%, respectively. There was no difference in adverse events or any of the measured primary and secondary outcomes.Conclusion:This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrollment and follow-up to address this topic is possible in this setting.

GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures

“…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 [ 20 , 21 ]. To our knowledge, this represents the first clinical trial to evaluate locally applied gentamicin for open tibial fractures in a low-income country.…”

Best Practices for Developing International Academic Partnerships in Orthopaedics

“…Over the past 10 years, the research relationship has grown, as has the research aptitude of the Tanzanian principal investigators, who serve as first authors on many of the study publications. More recently, a randomized clinical trial on local gentamicin use in open tibial fractures in Tanzania was initiated after garnering funding from both the OREF and the National Institutes of Health (NIH) 40,41 . This collaboration is an example of how bidirectional partnerships can result in a culture of inquiry that becomes selfsustaining as it inspires young investigators on both sides to work together for mutual gains.…”