Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations
研究概览
简要总结
The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.
详细描述
Cast sores result in pain, scarring and sometimes disfigurement. No study has specifically evaluated the efficacy of waterproof cast padding with respect to preventing lower extremity cast sores.
Comparison: Non-blinded randomization to waterproof or cotton/cotton-poly cast padding material in a pediatric population who have lower extremity casts that include the foot and are applied in the operating room. Comparison of cast sore incidence will be made in the two randomized groups.
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
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at Shriners Hospital for Children - Honolulu
- •Ages 0-18
- •Short leg, long leg, spica or Petrie cast that includes the foot
- •Cast applied in the operating room
排除标准
- •Ponsetti casts (club foot casts with no more surgery than Achilles tenotomy, age < 1 year)
- •cylinder casts or spicas which don't include the foot
结局指标
主要结局
Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations
时间窗: Time of cast application to final cast removal
次要结局
- Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.(Cast application to final cast removal)
研究者
Jonathan B. Pellett
Staff Orthopaedic Surgeon
Shriners Hospitals for Children