A Phase 4 interventional study of Vancomycin 1000 MG in Open Fracture, Trauma and Infection, Surgical Site, sponsored by University of Manitoba. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Manitoba · Phase 4, Interventional, and Treatment
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 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 and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive fixation of the fracture on deep surgical site infection, defined as a post-operative surgical infection requiring return to the operating room for irrigation and debridement with or without hardware removal/revision within the first six months following surgery.
Secondary Objectives:
To evaluate the effect of intra-operative intrawound topical vancomycin powder on superficial surgical site infection, defined as a post-operative infection that required antibiotic treatment but no return to the operating room, readmissions to hospital for post-operative surgical infection (deep or superficial), and hardware failure, defined as hardware loosening, loss of fixation, hardware fracture, or hardware migration, visualized either on imaging or found intra-operatively.
To evaluate differences in microbe characteristics in cultures taken intra-operatively in the take-back irrigation and debridement surgery in patients with deep surgical site infection.
To evaluate if the effect of intra-operative intrawound topical vancomycin powder changes based on fracture and patient characteristics: upper extremity versus lower extremity, Gustilo Classification, patients with documented Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and mechanism of injury.
To evaluate if certain fracture and patient characteristics: upper extremity versus lower extremity, Gustilo Classification, patients with documented Methicillin-resistant Staphylococcus aureus (MRSA) colonization, and by their mechanism of injury increases the risk of infection in both the treatment and control group.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's planned enrollment of 350 is above the median of 90 across 40 interventional studies indexed under Fractures, Open.
Browse Fractures, Open studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Powdered, 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
Drug: Vancomycin 1000 MG
Intravenous antibiotics with irrigation and debridement alone.
Powdered, 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
Also known as: Treatment
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.
Time frame: Within six months of definitive surgical orthopedic fixation
Superficial surgical site infection
A post-operative infection that required antibiotic treatment but no return to the operating room
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: During initial admission to hospital for open fracture
Plan to share: No
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Studies of the drug tested here: Vancomycin