Powdered Intrawound Vancomycin in Open Fractures Trial

Phase 4Not Yet RecruitingNCT06504992

University of Manitoba350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Powdered Intrawound Vancomycin in Open Fractures Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts