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


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
15 Jun 2023
Historique:
received: 05 04 2023
accepted: 24 05 2023
medline: 19 6 2023
pubmed: 16 6 2023
entrez: 15 6 2023
Statut: epublish

Résumé

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 orthopedic 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. 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 ninety 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. 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. Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.

Sections du résumé

BACKGROUND 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 orthopedic 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 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 ninety 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 CONCLUSIONS
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 BACKGROUND
Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.

Identifiants

pubmed: 37322521
doi: 10.1186/s13063-023-07410-0
pii: 10.1186/s13063-023-07410-0
pmc: PMC10268448
doi:

Substances chimiques

Gentamicins 0
Anti-Bacterial Agents 0

Banques de données

ClinicalTrials.gov
['NCT05157126']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

406

Subventions

Organisme : NIAMS NIH HHS
ID : 5K23AR079044-02
Pays : United States

Informations de copyright

© 2023. The Author(s).

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Auteurs

Billy T Haonga (BT)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Jamieson M O'Marr (JM)

Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco School of Medicine, 2550 23rd Street, Building 9, 2nd Floor, San Francisco, CA, 94110, USA.

Patrick Ngunyale (P)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Joshua Ngahyoma (J)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Justin Kessey (J)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Ibrahim Sasillo (I)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Patricia Rodarte (P)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Tigist Belaye (T)

Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco School of Medicine, 2550 23rd Street, Building 9, 2nd Floor, San Francisco, CA, 94110, USA.

Eleni Berhaneselase (E)

Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco School of Medicine, 2550 23rd Street, Building 9, 2nd Floor, San Francisco, CA, 94110, USA.

Edmund Eliezer (E)

Muhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.

Travis C Porco (TC)

F.I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94122, USA.
Department of Ophthalmology, University of California San Francisco, 10 Koret Way, San Francisco, CA, 94143, USA.
Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th St. 2nd Floor, San Francisco, CA, 94158, USA.

Saam Morshed (S)

Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco School of Medicine, 2550 23rd Street, Building 9, 2nd Floor, San Francisco, CA, 94110, USA.

David W Shearer (DW)

Department of Orthopaedic Surgery, Institute for Global Orthopaedics and Traumatology, University of California San Francisco School of Medicine, 2550 23rd Street, Building 9, 2nd Floor, San Francisco, CA, 94110, USA. david.shearer@ucsf.edu.

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