Accès ouvert

GO-Tibia: a masked, randomized control trial evaluating Gentamicin versus saline in Open Tibia fractures

Article scientifique 2023 Anglais

Résumé

Abstract Background: The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low and low-middle income countries. These injuries are orthopaedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability, however no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different. • Methods: This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age>18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred and nighty patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture related infection occurring during the course of the 12-month follow-up. Discussion: This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures. Trial registration: Clinicaltrials.gov identifier: NCT05157126. Registered on December 14th, 2021.

Citer ce document

Haonga, B., O’Marr, J., Ngunyale, P., Ngahyoma, J., Kessey, J., Sasillo, I., Rodarte, P., Belaye, T., Berhaneselase, E., Eliezer, E., Porco, T., Morshed, S., Shearer, D. (2023). GO-Tibia: a masked, randomized control trial evaluating Gentamicin versus saline in Open Tibia fractures. https://doi.org/10.21203/rs.3.rs-2782350/v1

Accès au document

Texte intégral en lecture en ligne, réservé aux abonnés SPHAERO et aux membres de l'institution. Se connecter

Voir l'article sur le site de la revue

Auteur(s)

Billy T. Haonga Jamieson O’Marr Patrick Ngunyale Joshua Ngahyoma Justin Kessey Ibrahim Sasillo Patricia Rodarte Tigist Belaye Eleni Berhaneselase Edmund Eliezer Travis C. Porco Saam Morshed David Shearer

Statistiques

Consultations : 1

Téléchargements : 0