Vancomycin Powder for Broken Bones
(PIVOT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMadison Price, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Manitoba

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gabriel Larose, MD, MSc, FRCSC

Principal Investigator

University of Manitoba

Madison Price, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for patients with open fractures in their arms or legs. They must be undergoing surgery to fix the fracture and can receive standard IV antibiotics. People who have allergies to vancomycin, are pregnant, under 18, or have other infections that could affect results aren't eligible.

Inclusion Criteria

I am 18 years old or older.

I have an open fracture classified as Gustilo Type I to IIIc.

I can go to follow-up appointments for 6 months after surgery.

See 1 more

Exclusion Criteria

Patients with known vancomycin allergy, drug administration reaction, or other sensitivities to vancomycin

Patients with open fracture already infected at time of enrollment

Patients with current positive blood cultures (bacteremia) at time of enrollment

See 6 more

Treatment Details

Interventions

Powdered Intrawound Vancomycin (Anti-bacterial)

Trial OverviewThe study tests if adding powdered vancomycin directly into the wound during surgery reduces infection rates compared to just using IV antibiotics with cleaning and removal of damaged tissue.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Powdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement

Group II: ControlActive Control1 Intervention

Intravenous antibiotics with irrigation and debridement alone.