NCT06193330尚未招募不适用
Use of Antibiotics-cement Coated Plate in the Treatment of Gustilo-Anderson Type III Long Bone Fractures in Low- and Middle-income Countries vs External Fixation: A Multi-centre Randomized Control Trial
Oluwasegun Aremu4 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 178
- 试验地点
- 4
- 主要终点
- number of participants with fracture-related infection after 1 year
研究概览
简要总结
The purpose of the study is to assess whether infection rate is reduced with use of antibiotic-coated plate in severe open tibial fractures compare to use of external fixators
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age ≥ 18yrs,
- •Gustilo-Anderson IIIA and IIIB open fractures,
- •involvement of any long bone fractures that can be fixed with either plate or uniplanar external fixation,
- •wound can be closed primarily, with skin graft or flap, or can heal secondarily
排除标准
- •Patients with traumatic brain injury,
- •spinal cord injury,
- •severe burns,
- •1 long bone fractures,
- •refusal to consent,
- •history of allergies to ceftriaxone or sulbactam,
- •fractures associated with vascular injury
- •and non-compliance with follow-up.
结局指标
主要结局
number of participants with fracture-related infection after 1 year
时间窗: one year
participants will be followed-up for one year and occurrence of infection at any point during this time period will be noted and recorded once
次要结局
- number of participants who require re-operation after one year(one year)
- number of participants who have fracture union after one year(one year)
- change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up(one year)
研究者
Oluwasegun Aremu
DR
University College Hospital, Ibadan
研究点 (4)
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