Powdered Intrawound Vancomycin in Open Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Deep surgical site infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Vancomycin 1000 MG (Drug)
结局指标
主要结局
Deep surgical site infection
时间窗: Within six months of definitive surgical orthopedic fixation
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.
次要结局
- Fracture Gustilo Classification(At time of definitive surgical orthopedic fixation.)
- Superficial surgical site infection(Within six months of definitive surgical orthopedic fixation)
- Microbe sensitivity(Up until six months following definitive fixation)
- Mechanism of injury(At time of initial open fracture)
- Hardware failure visualized either on imaging or found intra-operatively, until six months post definitive fixation(Up until six months following definitive fixation)
- Fracture location(At time of initial open fracture)
- MRSA colonization(During initial admission to hospital for open fracture)
研究者
Madison Price
Doctor of Medicine, PI under Dr. Gabriel Larose
University of Manitoba