Status:
NOT_YET_RECRUITING
Powdered Intrawound Vancomycin in Open Fractures Trial
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Health Sciences Centre, Winnipeg, Manitoba
Conditions:
Open Fracture
Trauma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-opera...
Detailed Description
Primary Objective: To evaluate the effect of intra-operative intrawound topical vancomycin powder on open fractures in addition to the current best practice of intravenous antibiotics with irrigation...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- Patients who have other forms of local antibiotics that are left in place at the end of the definitive fixation surgery (e.g., antibiotic loaded cement or polymethyl methacrylate (PMMA) beads)
- Patients who do not speak English
- Patients who are currently pregnant
- Patients who are unable to provide consent and do not have a substitute decision maker able to provide consent
- Patients who will have severe difficulty with follow up
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06504992
Start Date
November 1 2024
End Date
September 1 2029
Last Update
September 19 2024
Active Locations (1)
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1
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9