Powdered Intrawound Vancomycin in Open Fractures Trial

Официальное название

Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Deep surgical site infection [Срок оценки: Within six months of definitive surgical orthopedic fixation]

Вторичные конечные точки (7)

• Superficial surgical site infection [Срок оценки: Within six months of definitive surgical orthopedic fixation]
• Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation [Срок оценки: Up until six months following definitive fixation]
• Microbe sensitivity [Срок оценки: Up until six months following definitive fixation]
• Fracture location [Срок оценки: At time of initial open fracture]
• Fracture Gustilo Classification [Срок оценки: At time of definitive surgical orthopedic fixation.]
• Mechanism of injury [Срок оценки: At time of initial open fracture]
• MRSA colonization [Срок оценки: During initial admission to hospital for open fracture]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Health Sciences Centre Winnipeg — Winnipeg

Идентификаторы

NCT: NCT06504992 · HS26510 (B2024:071)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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