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The Treatment of Type I Open Fractures in Pediatrics

Study acronym: PROOF
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jan 2026 to Jun 2027
    • Study completion date: Jun 2026 to Sep 2027
    v12
  2. Primary completion date: Jan 2025 to Jan 2026
    • Study completion date: Dec 2025 to Jun 2026
    v11
  3. Primary completion date: Oct 2022 to Jan 2025
    • Study completion date: May 2023 to Dec 2025
    • Collaborators: 16 to 17
    v10
  4. Primary completion date: Oct 2020 to Oct 2022
    • Study completion date: May 2021 to May 2023
    • Collaborators revised (16)
    v9
  5. Primary completion date: Oct 2018 to Oct 2020v8 Show 4 more changesShow less
    • Study completion date: Oct 2018 to May 2021
    • Secondary endpoints: details revised at 2 of 2 entries
    • Collaborators: 17 to 16
    • Study description expanded, about 1 word
Show 6 earlier versionsHide 6 earlier versions
  1. Phase: Phase 3 to Not applicable
    • Secondary endpoints revised (2)
    • Site contact updated
    • Collaborators: 18 to 17
    v7
  2. Phase: Phase 1/2 to Phase 3
    • Collaborators: 19 to 18
    v6
  3. Enrollment target: 200 to 300v5 Show 6 more changesShow less
    • Primary and study completion dates: Aug 2016 to Oct 2018
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study site revised
    • Collaborators expanded, about 75 words
    • Publications: 3 to 9
  4. Primary and study completion dates: Mar 2014 to Aug 2016
    • Study site revised
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2009 to Mar 2010
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.
Trial Details
NCT Number NCT00870064
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: Provincial Health Services Authority British Columbia, University of Mississippi Medical Center, MultiCare Mary Bridge Children's Hospital & Health Center, Yale New Haven Health System Center for Healthcare Solutions, University of New Mexico Carrie Tingley Hospital, IWK Health Centre, Phoenix Children's Hospital, Children's Hospital Colorado, Nationwide Children's Hospital, Morristown Medical Center, NYUMC-Hospital for Joint Diseases, Children's Medical Center Dallas, Johns Hopkins University, Orthopaedic Institute for Children, Children's Hospital Los Angeles, St. Christopher's Hospital for Children, Children's Hospital of Orange County
Conditions
(from sponsor)		 Fractures, Open
Related terms Fractures, Open
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov