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.
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
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).
Parallel
Vancomycin 1000 MG
DrugPowdered, 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
Deep surgical site infection
A post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removal/revision after the definitive fixation.
Superficial surgical site infection
A post-operative infection that required antibiotic treatment but no return to the operating room
Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation
Hardware loosening, loss of fixation, hardware fracture, or hardware migration visualized either on imaging or found intra-operatively
Microbe sensitivity
In patients with deep surgical site infection, the gram stain and sensitivity and resistance to antibiotics of cultures taken intra-operatively in the take-back irrigation and debridement surgery
Fracture location
Whether the fracture is in the upper extremity: clavicle, humerus, radius, ulna, metacarpals and phalanges (fingers) versus lower extremity: femur, tibia, fibula, metatarsals, and phalanges (toes).
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University of Manitoba
Lead sponsor
Health Sciences Centre, Winnipeg, Manitoba
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
