NCT05231148招募中不适用
Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Non union scoring system
研究概览
简要总结
- Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . [6]
- infected nonunion mean the bone has previous fracture , the bone not healed may be one of the reasons it didn't heal because there is sub-acute infection , there is low grade colonization into the bone or around the wound preventing the bone from healing , it different from infected fracture which occur fairly acutely. [6, 7]
- Infected nonunion treated with systemic antibiotics alone, without using local antibiotic delivery systems associated with higher recurrence and reoperation rates. [7]
- This led to the development and use of medical-grade calcium sulfate (CS), CS facilitates osseous healing in an osteoconductive fashion by filling the bone void and preventing fibrous tissue
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient at any age and of any sex with infected non united fracture of long or short bones
排除标准
- •Presence of previous vascular injury or pathological fracture
- •Refusal to participate
- •Inability to provide informed consent
- •Allergy or sensitivity to vancomycin or tobramycin
- •Patient with impaired renal function
- •Patient with hypercalcemia
结局指标
主要结局
Non union scoring system
时间窗: one year
Non-Union Scoring System (NUSS) aims to classify non-unions according to their severity and relate them to four treatment categories.
Karlström-Olerud physical function scale
时间窗: one year
Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.
次要结局
未报告次要终点
研究者
Abdelraheem Mohamed Sonbol
Resident of orthopedic surgery
Sohag University
研究点 (1)
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