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Tobramycin Injection to Prevent Infection in Open Fractures

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Primary and study completion dates changed from estimate of Jul 2026 to Jul 1, 2026 · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 3 of 5 entries Show 3 more changesShow less
    • Primary and study completion dates changed from estimate of Jul 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Minor Re-verified, no change to tracked fieldsv12
  3. Minor Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Aug 2026 to Jul 2026 · Site details revised at 3 of 3 sitesv11 Show 2 more changesShow less
    • Primary and study completion dates: Aug 2026 to Jul 2026
    • Site details revised at 3 of 3 sites
  4. Notable Primary and study completion dates: Sep 2025 to Aug 2026 Site details revised at 1 of 3 sitesv10 Show 1 more changeShow less
    • Site details revised at 1 of 3 sites
  5. Minor Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Study sites: 2 to 3v8
  2. Minor Study Status, Contacts/Locations, Referencesv7
  3. Notable Lead sponsor: David Landy to Massachusetts General Hospital Enrollment target: 300 to 600 · Study sites: 1 to 2v6 Show 2 more changesShow less
    • Enrollment target: 300 to 600
    • Study sites: 1 to 2
  4. Notable Lead sponsor: Arun Aneja to David Landyv5
  5. Minor Re-verified, no change to tracked fieldsv4
  6. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2021 to Jan 10, 2022 · Interventions: Saline (Drug), Tobramycin Injection (Drug) to Tobramycin Injection (Drug) · Secondary endpoints revised (5) · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2021 to Jan 10, 2022
    • Interventions: Saline (Drug), Tobramycin Injection (Drug) to Tobramycin Injection (Drug)
    • Secondary endpoints revised (5)
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  7. Notable Start date: Sep 2021 to Dec 2021v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04964947
Lead Sponsor Massachusetts General Hospital
Collaborators: United States Department of Defense
Conditions Wound Infection, Fractures, Open, Surgical Site Infection
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov