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Powdered Intrawound Vancomycin in Open Fractures Trial

Study acronym: PIVOT
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Phase: Phase 3 to Phase 4
    • Start date: Sep 1, 2024 to Nov 1, 2024
    v3
  2. Study title shortened, about 3 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.
Trial Details
NCT Number NCT06504992
Lead Sponsor University of Manitoba
Collaborators: Health Sciences Centre, Winnipeg, Manitoba
Conditions
(from sponsor)		 Open Fracture, Trauma, Infection, Surgical Site, Fractures, Open, Wound Infection, Fractures, Bone, Post-Operative Wound Infection
Related terms Fractures, Bone, Fractures, Open, Infections, Surgical Wound Infection, Wound Infection, Wounds and Injuries
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov