GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures.
Fracture-related Infection
Gentamicin
Local antibiotics
Open tibia fractures
Randomized control
Tanzania
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
15 Jun 2023
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
406Subventions
Organisme : NIAMS NIH HHS
ID : 5K23AR079044-02
Pays : United States
Informations de copyright
© 2023. The Author(s).
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