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Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Study acronym: BeadsvsVac
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 34 to 35v32
  2. Site details revised at 2 of 34 sitesv31
  3. Site contacts updated at 4 of 34 sitesv30
  4. Study sites: 33 to 34v29
  5. Study sites: 32 to 33v28
Show 26 earlier versionsHide 26 earlier versions
  1. Site details revised at 2 of 32 sitesv27
  2. Re-verified, no change to tracked fieldsv26
  3. Study sites: 31 to 32v25
  4. Study sites: 30 to 31v24
  5. Study sites: 29 to 30
    • Collaborators: 1 to 2
    v23
  6. Study sites: 28 to 29v22
  7. Study sites: 26 to 28v21
  8. Site contacts updated at 1 of 26 sitesv20
  9. Study sites: 25 to 26v19
  10. Study sites: 24 to 25v18
  11. Study sites: 22 to 24v17
  12. Study sites: 21 to 22v16
  13. Study sites: 20 to 21v15
  14. Primary completion date: Mar 31, 2025 to Mar 31, 2027
    • Study sites: 18 to 20
    • Study completion date: Oct 1, 2025 to Oct 1, 2027
    v14
  15. Eligibility criteria expanded, about 10 wordsv13
  16. Study sites: 17 to 18v12
  17. Study sites: 16 to 17v11
  18. Study sites: 14 to 16v10
  19. Study sites: 13 to 14v9
  20. Study sites: 12 to 13v8
  21. Study sites: 1 to 12v7
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2023 to Nov 5, 2023
    v6
  23. Start date: Jul 15, 2023 to Sep 30, 2023v5
  24. Start date: Jun 1, 2023 to Jul 15, 2023v4
  25. Start date: Mar 1, 2023 to Jun 1, 2023v3
  26. Eligibility criteria expanded, about 36 words
    • Secondary endpoints revised (4)
    • Study description shortened, about 14 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.
Trial Details
NCT Number NCT05615844
Lead Sponsor University of Maryland, Baltimore
Collaborators: McMaster University, University of California, Irvine
Conditions
(from sponsor)		 Open tíbia Fracture
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov