Powdered Intrawound Vancomycin in Open Fractures Trial

NCT06504992 | Not Yet Recruiting Phase 4

• 1 other identifier: HS26510 (B2024:071)
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Fracture; Trauma; Infection, Surgical Site; Fractures, Open; Wound Infection; Fractures, Bone; Post-Operative Wound Infection

Keywords

open fracture; vancomycin; infection; trauma; intrawound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Superficial surgical site infection

  Within six months of definitive surgical orthopedic fixation

• Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation

  Up until six months following definitive fixation

• Microbe sensitivity

  Up until six months following definitive fixation

• Fracture location

  At time of initial open fracture

• Fracture Gustilo Classification

  At time of definitive surgical orthopedic fixation.

Study Arms (2)

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

Drug: Vancomycin 1000 MG

Control

NO INTERVENTION

Intravenous antibiotics with irrigation and debridement alone.

Interventions

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

Also known as: Treatment

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre, Winnipeg, Manitoba: collaborator

Study Sites (1)

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Fractures, Open; Wounds and Injuries; Surgical Wound Infection; Wound Infection; Fractures, Bone; Infections

Interventions

Vancomycin; Therapeutics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gabriel Larose, MD, MSc, FRCSC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Madison Price, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Larose, MD, MSc, FRCSC

CONTACT

2047872261; glarose@hsc.mb.ca

Madison Price, MD

CONTACT

pricem@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine, PI under Dr. Gabriel Larose

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)