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| Name | Class |
|---|---|
| Health Sciences Centre, Winnipeg, Manitoba | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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 |
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| Control | No Intervention | Intravenous antibiotics with irrigation and debridement alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin 1000 MG | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Larose, MD, MSc, FRCSC | Contact | 2047872261 | glarose@hsc.mb.ca | |
| Madison Price, MD | Contact | pricem@myumanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Larose, MD, MSc, FRCSC | University of Manitoba | Principal Investigator |
| Madison Price, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre Winnipeg | Winnipeg | Manitoba | R3A 1R9 | Canada |
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| ID | Term |
|---|---|
| D005597 | Fractures, Open |
| D014947 | Wounds and Injuries |
| D013530 | Surgical Wound Infection |
| D014946 | Wound Infection |
| D050723 | Fractures, Bone |
| D007239 | Infections |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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The study is a randomized controlled trial blinded to participants and end-point assessors. Participants will be randomized to either receiving the treatment, intra-operative intrawound topical vancomycin powder on open fractures in addition to intravenous antibiotics with irrigation and debridement, or the control, intravenous antibiotics with irrigation and debridement alone.
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|
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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |