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NCT Number: NCT04964947

Tobramycin Injection to Prevent Infection in Open Fractures

The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kentucky, Lexington, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Open fracture to arm, leg, or both
  • Over the age of 18

Exclusion criteria

  • Under the age of 18
  • Allergy to tobramycin or any other antibiotic in the aminoglycoside family
  • Previously treated with a resorbable antibiotic carrier
  • Pregnancy

Treatment and study plan

Tobramycin Injection

Drug

80 milligrams of tobramycin diluted in 40 milliliters of normal saline

Primary outcomes

  1. Rate of infection

    Time frame: 1 year

    Rate of infection one year after open fracture fixation surgery.

Secondary outcomes

  1. Tobramycin effects on non-union

    Time frame: 3 months after surgery

    Modified radiographic union score for tibial fracture (mRUST) scores combined with clinical observation of functional weight bearing at 3 months will be assessed. If union status remains unclear, nonunion will be further defined as a need for secondary bone grafting or surgical intervention.

  2. Tobramycin effects on non-union

    Time frame: 6 months after surgery

    Modified radiographic union score for tibial fracture (mRUST) scores combined with clinical observation of functional weight bearing at 6 months will be assessed. If union status remains unclear, nonunion will be further defined as a need for secondary bone grafting or surgical intervention.

  3. Tobramycin effects on non-union

    Time frame: 12 months after surgery

    Modified radiographic union score for tibial fracture (mRUST) scores combined with clinical observation of functional weight bearing at 12 months will be assessed. If union status remains unclear, nonunion will be further defined as a need for secondary bone grafting or surgical intervention.

  4. Difference in bacterial specification between treatment and standard of care group.

    Time frame: 12 months

    Upon identification of a fracture-related infection within the first 12 months following surgical fixation, sterile intraoperative cultures will be obtained and grown over 21 days to determine bacterial speciation.

  5. Difference in antibiotic resistance between treatment and standard of care group.

    Time frame: 12 months

    Upon identification of a fracture-related infection within the first 12 months following surgical fixation, sterile intraoperative cultures will be obtained and grown over 21 days to determine antimicrobial resistance.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Does Prophylactic Local Tobramycin Injection Lower Open Fracture Infection Rates?

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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