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
Sponsors and collaborators
University of Manitoba
Lead sponsor
Health Sciences Centre, Winnipeg, Manitoba
Collaborator