Gentamicin Open Tibia Study

NCT05157126 | Recruiting Phase 4 DMC

• 2 other identifiers: 21-35369K23AR079044
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 1

Brief Summary

Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This study aims 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.

Conditions

Fracture Open Tibia

Outcome Measures

Primary Outcomes (1)

• Occurrence of fracture-related infection (FRI)

  Fracture-related infection is a consensus definition of infection after fracture treatment. It is diagnosed by an orthopaedic surgeon based on any of the following four diagnostic criteria: (1) fistula, sinus or wound breakdown; (2) purulent drainage from the wound or presence of pus during surgery; (3) phenotypically indistinguishable pathogens identified by culture from at least two separate deep tissue/implant specimens; or (4) presence of microorganisms in deep tissue taken during an operative intervention, as seen on histopathological examination. FRI diagnosis is likely to peak between 6 weeks and 6 months after surgery and has a non-normal time-to-event distribution, with incident cases rarely presenting later than 12 months after surgery. All events will be confirmed by an independent adjudication committee comprised of three masked, non-treating orthopaedic trauma surgeons.

  12 months

Secondary Outcomes (6)

• Occurrence of nonunion

  12 months

• Occurrence of unplanned fracture-related reoperation

  12 months

• Health-related quality-of-life (HRQOL) as measured by EQ-5D-3L (Swahili version)

  12 months

• Fracture healing by modified Radiographic Union Scale for Tibial fractures (mRUST score)

  12 months

• Clinical fracture healing by Function IndeX for Trauma (FIX-IT)

  12 months

Other Outcomes (2)

• Adverse events

  12 months

• Fold-change in creatinine level

  2 days

Study Arms (2)

Gentamicin

EXPERIMENTAL

The intervention consists of 80mg of liquid gentamicin diluted in 5 mL normal saline (16mg/mL). The solution is injected by inserting a 22-gauge needle down to bone through an anteromedial approach at the level of the fracture site such that the injected solution fills the wound cavity. A total of 5mL of study solution will be administered.

Drug: Gentamicin

Saline

PLACEBO COMPARATOR

The control consists of 5 mL normal saline injected immediately after wound closure at the open fracture site. The solution is injected by inserting a 22-gauge needle down to bone through an anteromedial approach at the level of the fracture site such that the injected solution fills the wound cavity. A total of 5mL of study solution will be administered.

Drug: normal Saline

Interventions

Gentamicin DRUG

Liquid gentamicin administered at the open fracture site

Gentamicin

normal Saline DRUG

Normal saline administered at the open fracture site

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• Open tibial shaft fracture meeting the following criteria:
• Orthopaed Trauma Association (OTA) Type 42
• Primarily closable wound
• Gustilo-Anderson (GA) Type I, II, or IIIA

You may not qualify if:

• Time from injury to presentation \> 48 hours
• Time from injury to surgery \> 7 days
• Aminoglycoside allergy
• GA IIIB or IIIC open fractures
• Bilateral open tibial fractures
• Severe brain (GCS\<12) or spinal cord injury
• Severe vascular injury
• Severe burns (\>10% Total Body Surface Area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
• Pathologic fracture
• History of active limb infection, ipsilaterally
• Unlikely to complete follow-up

Sponsors & Collaborators

• University of California, San Francisco: lead
• Muhimbili Orthopaedic Institute: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Orthopedic Research and Education Foundation: collaborator

Study Sites (1)

Muhimbili Orthopaedic Institute

Dar es Salaam, Tanzania

RECRUITING

Related Publications (1)

• Haonga BT, O'Marr JM, Ngunyale P, Ngahyoma J, Kessey J, Sasillo I, Rodarte P, Belaye T, Berhaneselase E, Eliezer E, Porco TC, Morshed S, Shearer DW. GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures. Trials. 2023 Jun 15;24(1):406. doi: 10.1186/s13063-023-07410-0.

  PMID: 37322521 DERIVED

MeSH Terms

Interventions

Gentamicins; Saline Solution

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• David W Shearer, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Billy T Haonga, MD

  Muhimbili Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Shearer, MD, MPH

CONTACT

628-206-8812; david.shearer@ucsf.edu

Tigist Belaye, MPA

CONTACT

628-206-8812; tigist.belaye@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collectors (research coordinators) and data analysts will also be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center individually-randomized placebo-controlled superiority trial

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: September 1, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)