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Recruiting NCT05157126

Gentamicin Open Tibia Study

Phase IV Interventional Fracture Open Tibia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gentamicin, normal Saline.
Who it may be relevant to
Registry conditions: Fracture Open Tibia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Tibial shaft (shinbone) fractures are the most common major fracture of the lower leg and are frequently associated with a break in the skin known as an open fracture. Because the bone is exposed by the open wound, open tibial fractures are often complicated by infection and failure of bone healing, which can lead to long-lasting disability and in some cases amputation. Intravenous antibiotics administered early after injury are a well-established measure to prevent fracture-related infection (FRI), but their effectiveness is limited by poor blood flow at the fracture site and inability to achieve high local concentrations with systemic administration. Gentamicin applied locally within the open fracture wound is a promising adjunctive measure to reduce the risk of FRI after these injuries, but there are no high-quality clinical trials evaluating its use.

This will be the first randomized trial evaluating locally administered gentamicin to reduce infection in a fracture population. If efficacious, local gentamicin is likely to be a highly cost-effective preventive strategy for FRI and may ultimately be cost saving. Although these findings will originate from a low-income country, results may be generalizable to populations in both high and low-income countries and could therefore significantly reduce the global burden of open fractures.

Interventions

  • Drug Gentamicin
    Liquid gentamicin administered at the open fracture site
  • Drug normal Saline
    Normal saline administered at the open fracture site

Primary outcome measures

  • Occurrence of fracture-related infection (FRI) [Time frame: 12 months]
Secondary outcome measures (6)
  • Occurrence of nonunion [Time frame: 12 months]
  • Occurrence of unplanned fracture-related reoperation [Time frame: 12 months]
  • Health-related quality-of-life (HRQOL) as measured by EQ-5D-3L (Swahili version) [Time frame: 12 months]
  • Fracture healing by modified Radiographic Union Scale for Tibial fractures (mRUST score) [Time frame: 12 months]
  • Clinical fracture healing by Function IndeX for Trauma (FIX-IT) [Time frame: 12 months]
  • Occurence of FRI Suggestive Criteria [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Tanzania · 1 center
  • Muhimbili Orthopaedic Institute — Dar es Salaam

Publications

  • 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

Identifiers

NCT: NCT05157126 · 21-35369 · K23AR079044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗