Evidence map›Paper›PMID 33568230›Full record

ArticlePilot and feasibility studies2021

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.

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 and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03559400 (A Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin Versus Saline in Open Tibia Fractures), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT03559400 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of California, San FranciscoRan2019 to 2021Enrolled100ConditionsOpen Tibia FractureArmslocal gentamicin injection, placebo saline injection
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
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  5. Review
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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

11 authors at 2 institutions in 2 countries.

Ericka P von KaepplerDepartment 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/0000-0002-9495-3755
Claire DonnelleyDepartment 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.
Syed H AliDepartment 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.
Heather J RobertsDepartment 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.
John M IbrahimDepartment 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.
Hao-Hua WuDepartment 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 N EliezerMuhimbili Orthopaedic Institute, Muhimbili National Hospital, Kalenga Street, Dar es Salaam, Tanzania.
Travis C PorcoF.I. Proctor Foundation, University of California San Francisco, 513 Parnassus Avenue, San Francisco, CA, 94122, USA.
Billy T HaongaMuhimbili Orthopaedic Institute, Muhimbili National Hospital, Kalenga Street, Dar es Salaam, Tanzania.
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.
University of California, San Francisco · USMuhimbili National Hospital · TZ

Funding

Orthopaedic Trauma Association International 4279SuperNOVA UCSF Department of Orthopaedic Surgery NAUCSF Hellman Fellowship Program A7029503
6 · The paper itself

Abstract

backgroundOpen 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.

methodsWe 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.

trial registrationClinicalTrials.gov, Registration # NCT03559400 ; Registered June 18, 2018.

Indexed as

AntibioticsFracture-related infectionGentamicinGlobal healthOpen tibia fractureOrthopaedic surgery

Identifiers

PMID33568230
PMCPMC7874655
OpenAlexW3126289799

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.