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Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

Study acronym: iVAC
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 2 to 6v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2024 to Jan 1, 2025
    • Study sites: 0 to 2
    • Study title shortened, about 5 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.
Trial Details
NCT Number NCT06337292
Lead Sponsor Major Extremity Trauma Research Consortium
Conditions
(from sponsor)		 Fracture of Tibia, Wound Heal, Infected Wound, Wound Complication, Wound Dehiscence
Related terms Tibial Fractures, Wound Infection
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov