MedDataX Logo

Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

NCT ID: NCT03559400

Last Updated: 2023-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2021-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Local application of antibiotics directly to the traumatic wound is a promising strategy for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This pilot study aims to assess feasibility of a randomized controlled trial to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania. If proven effective, local gentamicin would be a highly cost-effective strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This pilot study is being conducted in Dar es Salaam, Tanzania to assess the feasibility of a masked, placebo-controlled, randomized trial to compare local gentamicin injection to saline injection in open tibial shaft fractures. The study will enroll patients within 1 week of injury. The active or placebo agent will be administered during the initial surgical debridement based on a web-based randomization tool. Patients will be followed for 1 year after surgery to assess for the occurrence of fracture-related infection (FRI), a consensus definition of infection after open fracture or insertion of internal fixation to treat fracture. Additional clinical and economic endpoints will also be measured.

Depending on the outcome of the feasibility study, we may undertake a definitive trial to test the effectiveness of local gentamicin to prevent FRI. If proven effective, local gentamicin would impact the clinical care of open fracture patients both in Tanzania and likely in high-income settings as well. These data will also deepen the understanding of the clinical and economic impact of FRI in open fracture populations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Tibia Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients will receive gentamicin in saline solution or placebo saline injection while under anesthesia during the index surgery. Only the local research pharmacist, the UCSF clinical trial manager, and the DSMC will be unmasked.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

gentamicin injection at fracture site

Subjects with an open tibia fracture who receive gentamicin in saline solution administered after closure at the time of initial debridement.

Group Type EXPERIMENTAL

local gentamicin injection

Intervention Type DRUG

Treatment includes debridement and administration of the local antibiotic which will consist of 80mg of liquid gentamicin diluted in 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.

placebo saline injection at fracture site

Subjects with an open tibia fracture who receive placebo saline solution administered after closure at the time of initial debridement.

Group Type PLACEBO_COMPARATOR

placebo saline injection

Intervention Type DRUG

Treatment includes debridement and administration of the local antibiotic which will consist of 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

local gentamicin injection

Treatment includes debridement and administration of the local antibiotic which will consist of 80mg of liquid gentamicin diluted in 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.

Intervention Type DRUG

placebo saline injection

Treatment includes debridement and administration of the local antibiotic which will consist of 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female patients age 18 or older
2. Diagnosis of an acute open tibial shaft fracture meeting the following criteria:

1. AO/OTA Type 42
2. Primarily closable wound
3. Type I, II, or IIIA Gustilo- Anderson (GA) Classification

Exclusion Criteria

1. Time from injury to presentation \> 48 hours
2. Time from injury to surgery \>7 days
3. History of Aminoglycoside allergy
4. GA IIIB or IIIC open fractures
5. Bilateral open tibial fractures
6. Severe brain (GCS\<12) or spinal cord injury
7. Severe vascular injury
8. Sustained severe burns (\>10% total body surface area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
9. Pathologic fracture
10. History of active limb infection, ipsilaterally
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Muhimbili Orthopaedic Institute

OTHER

Sponsor Role collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Shearer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muhimbili Orthopaedic Institute

Dar es Salaam, , Tanzania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Tanzania

References

Explore related publications, articles, or registry entries linked to this study.

von Kaeppler EP, Donnelley C, Ali SH, Roberts HJ, Ibrahim JM, Wu HH, Eliezer EN, Porco TC, Haonga BT, Morshed S, Shearer DW. 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. Pilot Feasibility Stud. 2021 Feb 10;7(1):47. doi: 10.1186/s40814-021-00766-7.

Reference Type DERIVED
PMID: 33568230 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23AR079044

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-23950

Identifier Type: -

Identifier Source: org_study_id