A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania

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A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania


JournalPilot and Feasibility Studies
Article typeJournal research article – Clinical research
Publication date – Feb – 2021
Authors – Ericka P. von Kaeppler, Claire Donnelley, Syed H. Ali, Heather J. Roberts, John M. Ibrahim, Hao-Hua Wu, Edmund N. Eliezer, Travis C. Porco, Billy T. Haonga, Saam Morshed & David W. Shearer , Claire Donnelley, Syed H. Ali, Heather J. Roberts, John M. Ibrahim, Hao-Hua Wu, Edmund N. Eliezer, Travis C. Porco, Billy T. Haonga, Saam Morshed, David W. Shearer
Keywordsfracture-related infection, Function Index for Trauma, gentamicin to placebo
Open access – Yes
SpecialityTrauma and orthopaedic surgery
World region Eastern Africa
Country: Tanzania
Language – English
Submitted to the One Surgery Index on February 16, 2021 at 7:27 am
Abstract:

Abstract
Background
Open tibia fractures are a major source of disability in low- and middle-income countries (LMICs) due to the high incidence of complications, particularly infection and chronic osteomyelitis. One proposed adjunctive measure to reduce infection is prophylactic local antibiotic delivery, which can achieve much higher concentrations at the surgical site than can safely be achieved with systemic administration. Animal studies and retrospective clinical studies support the use of gentamicin for this purpose, but no high-quality clinical trials have been conducted to date in high- or low-income settings.

Methods
We describe a protocol for a pilot study conducted in Dar es Salaam, Tanzania, to assess the feasibility of a single-center masked randomized controlled trial to compare the efficacy of locally applied gentamicin to placebo for the prevention of fracture-related infection in open tibial shaft fractures.

Discussion
The results of this study will inform the design and feasibility of a definitive trial to address the use of local gentamicin in open tibial fractures. If proven effective, local gentamicin would be a low-cost strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

OSI Number – 20935

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