Powdered Intrawound Vancomycin in Open Fractures Trial

Official title

Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial

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.

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.

Interventions

• Drug 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

Primary outcome measures

• Deep surgical site infection [Time frame: Within six months of definitive surgical orthopedic fixation]

Secondary outcome measures (7)

• Superficial surgical site infection [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 [Time frame: Up until six months following definitive fixation]
• Microbe sensitivity [Time frame: Up until six months following definitive fixation]
• Fracture location [Time frame: At time of initial open fracture]
• Fracture Gustilo Classification [Time frame: At time of definitive surgical orthopedic fixation.]
• Mechanism of injury [Time frame: At time of initial open fracture]
• MRSA colonization [Time frame: During initial admission to hospital for open fracture]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Health Sciences Centre Winnipeg — Winnipeg

Identifiers

NCT: NCT06504992 · HS26510 (B2024:071)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗