Powdered Intrawound Vancomycin in Open Fractures Trial

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About 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.

Eligibility criteria

Qualifiers

18 years or older at time of surgery

Patients with an open fracture classified as Gustilo Type I to IIIc in the clavicle, humerus, radius, ulna, metacarpals, upper extremity phalanges (fingers), femur, tibia, fibula and metatarsals and lower extremity phalanges (toes).

Open fracture treated operatively with plate(s) and screw(s) hardware fixation and intramedullary fixation (IM nail).

Able to attend standard of care follow up for six months post-operatively

Disqualifiers

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

Patients who have already had definitive fracture fixation before enrollment in the study

Patients with open fracture already infected at time of enrollment

Patients with current positive blood cultures (bacteremia) at time of enrollment (current, meaning they have not received treatment and now have negative most-recent blood cultures).

Trial design

Treatments tested in this trial

  • Vancomycin 1000 MG

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Manitoba

Lead sponsor

Health Sciences Centre, Winnipeg, Manitoba

Collaborator