Clinical Trial

Powdered Intrawound Vancomycin in Open Fractures Trial

Study acronym: PIVOT
Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-10; most recent amendment 2024-09-17.
Trial Details
NCT Number NCT06504992
Lead Sponsor University of Manitoba
Collaborators: Health Sciences Centre, Winnipeg, Manitoba
Conditions Open Fracture, Trauma, Infection, Surgical Site, Fractures, Open, Wound Infection, Fractures, Bone, Post-Operative Wound Infection
Enrollment 350 participants
Start Date 2024-11-01
Primary Completion 2028-09-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-09-19