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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 50% 484 → 242 participants
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Record History

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  1. Enrollment reduced: 484 → 242 participants
    • Study sites: 14 to 15
    v19
  2. 2 versions Re-verified since Mar 17, 2026, no change to tracked fieldsv17-v18
  3. Study sites: 15 to 14v16
  4. Re-verified, no change to tracked fieldsv15
  5. Study sites: 14 to 15v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 16 to 14v13
  2. Study sites: 15 to 16v12
  3. Site details revised at 2 of 15 sitesv11
  4. Site details revised at 2 of 15 sitesv10
  5. Study sites: 14 to 15v9
  6. Study sites: 13 to 14v8
  7. Study sites: 12 to 13v7
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 9 to 12
    • Start date changed from estimate of Jun 2023 to May 15, 2023
    v6
  9. Study sites revised (9)
    • Eligibility criteria shortened, about 1 word
    v5
  10. Start date: Mar 2023 to Jun 2023v4
  11. Start date: Dec 2022 to Mar 2023v3
  12. Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints: 3 to 14
    • Study description 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
Trial Details
NCT Number NCT05421741
Lead Sponsor Wake Forest University Health Sciences
Conditions
(from sponsor)		 Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture
Related terms Tibial Fractures
Enrollment 242 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov