Powdered Intrawound Vancomycin in Open Fractures Trial
NCT Number: NCT06504992
Acronym: PIVOT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Open Fracture|Trauma|Infection, Surgical Site|Fractures, Open|Wound Infection|Fractures, Bone|Post-Operative Wound Infection
Interventions: DRUG: Vancomycin 1000 MG
Sponsor: University of Manitoba
Collaborators: Health Sciences Centre, Winnipeg, Manitoba
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: Health Sciences Centre Winnipeg, Winnipeg, Manitoba, R3A 1R9, Canada

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-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.

Primary Outcome Measures: 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., Within six months of definitive surgical orthopedic fixation
Secondary Outcome Measures: Superficial surgical site infection, A post-operative infection that required antibiotic treatment but no return to the operating room, Within six months of definitive surgical orthopedic fixation|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, Up until six months following definitive fixation|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, Up until six months following definitive fixation|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)., At time of initial open fracture|Fracture Gustilo Classification, Open fracture classification from Type I to IIIc that classifies open fractures based on extent of bone, soft tissue and vascular injuries., At time of definitive surgical orthopedic fixation.|Mechanism of injury, Mechanism of injury will be categorized as:

i. Motor vehicle collision: car occupant, pedestrian, motorcyclist, other ii. Other Vehicle Accident: all-terrain vehicle (ATV), bicycle, snowmobile iii. Fall: from own height (slip/stumble), from height less than or equal to 3 metres, from height greater than 3 metres iv. Laceration v. Striking with blunt object (unintentional) vi. Crush injury vii. Sport related injury viii. Interpersonal violence: stabbing, striking with sharp object (e.g., machete), striking with blunt object, gunshot, other, At time of initial open fracture|MRSA colonization, Nasal swab for MRSA that is routinely taken for all patients admitted to the study's hospital, During initial admission to hospital for open fracture