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Intramedullary Calcium Sulfate Antibiotic Depot

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 51% 497 → 242 participants
See other at-risk trials from Wake Forest University Health Sciences

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 497 → 242 participants
    • Study sites: 10 to 12
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 19 of 21 entries
  2. Site details revised at 1 of 10 sitesv16
  3. Site details revised at 4 of 10 sitesv15
  4. 3 versions Re-verified since Nov 29, 2024, no change to tracked fieldsv12-v14
  5. Study sites: 9 to 10v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 5 to 9v10
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Apr 8, 2024
    • Site details revised at 5 of 5 sites
    v9
  3. Start date: May 2024 to Jun 2024v8
  4. Start date: Apr 2024 to May 2024v7
  5. Study sites: 1 to 5v6
  6. Start date: Feb 2024 to Apr 2024v5
  7. Start date: Dec 2023 to Feb 2024v4
  8. Start date: Oct 2023 to Dec 2023v3
  9. Secondary endpoints revised (21)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.
Trial Details
NCT Number NCT05766670
Lead Sponsor Wake Forest University Health Sciences
Conditions
(from sponsor)		 Open tíbia Fracture, Osteomyelitis Tibia, Tibial Fractures
Related terms Tibial Fractures
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov