Powdered Intrawound Vancomycin in Open Fractures Trial

NCT ID: NCT06504992

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2029-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Vancomycin 1000 MG

Intervention Type: 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

Control

Intravenous antibiotics with irrigation and debridement alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vancomycin 1000 MG

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

Intervention Type: DRUG

Other Intervention Names

Treatment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Sciences Centre, Winnipeg, Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Madison Price

Doctor of Medicine, PI under Dr. Gabriel Larose

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriel Larose, MD, MSc, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Madison Price, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

Countries

Canada

Central Contacts

Gabriel Larose, MD, MSc, FRCSC

Role: CONTACT

glarose@hsc.mb.ca

2047872261

Madison Price, MD

Role: CONTACT

pricem@myumanitoba.ca

Other Identifiers

HS26510 (B2024:071)

Identifier Type: -

Identifier Source: org_study_id