Evidence map›Paper›PMID 37322521›Full record

Trial reportTrials2023

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

Billy T Haonga, Jamieson M O'Marr, Patrick Ngunyale, Joshua Ngahyoma, Justin Kessey, Ibrahim Sasillo, Patricia Rodarte, Tigist Belaye, Eleni Berhaneselase, Edmund Eliezer and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05157126 (A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05157126 phase4recruitingnot on this map

A Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2029Enrolled890ConditionsFracture Open TibiaArmsGentamicin, normal Saline
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 2 countries.

Billy T HaongaMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Jamieson M O'MarrDepartment 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.ORCID http://orcid.org/0000-0002-1755-5825
Patrick NgunyaleMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Joshua NgahyomaMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Justin KesseyMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Ibrahim SasilloMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Patricia RodarteMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Tigist BelayeDepartment 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 BerhaneselaseDepartment 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 EliezerMuhimbili Orthopaedic Institute, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Travis C PorcoF.I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94122, USA.
Saam MorshedDepartment 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 ShearerDepartment 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.
Muhimbili University of Health and Allied Sciences · TZUniversity of California, San Francisco · US

Funding

A Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia)K23AR079044 · NIAMS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI SHEARER, DAVID WILLIAM · 2021 to 2025
$804k
NIAMS NIH HHS 5K23AR079044-02NIAMS NIH HHS K23 AR079044
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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: 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 registrationClinicaltrials.gov NCT05157126. Registered on December 14, 2021.

Indexed as

GentamicinsTibial FracturesAdultAnti-Bacterial AgentsFracture HealingHumansMiddle AgedProspective StudiesTibiaTreatment OutcomeAnti-Bacterial AgentsGentamicinsFracture-related InfectionGentamicinLocal antibioticsOpen tibia fracturesRandomized controlTanzania

Identifiers

PMID37322521
PMCPMC10268448
OpenAlexW4380870228

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.