Clinical trial NCT06504992: Powdered Intrawound Vancomycin in Open Fractures Trial
Official title: Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Open Fracture
Trauma
Infection, Surgical Site
Fractures, Open
Wound Infection
Fractures, Bone
Post-Operative Wound Infection
Keywords: open fracture
vancomycin
infection
trauma
intrawound
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre, Winnipeg, Manitoba
First posted: 2024-07-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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-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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Deep surgical site infection
timeFrame: Within six months of definitive surgical orthopedic fixation
Secondary outcomes:
measure: Superficial surgical site infection
timeFrame: Within six months of definitive surgical orthopedic fixation
measure: Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation
timeFrame: Up until six months following definitive fixation
measure: Microbe sensitivity
timeFrame: Up until six months following definitive fixation
measure: Fracture location
timeFrame: At time of initial open fracture
measure: Fracture Gustilo Classification
timeFrame: At time of definitive surgical orthopedic fixation.
measure: Mechanism of injury
timeFrame: At time of initial open fracture
measure: MRSA colonization
timeFrame: During initial admission to hospital for open fracture
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Gabriel Larose, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Madison Price, MD
role: PRINCIPAL_INVESTIGATOR
References: