Effectiveness of Cotton Sock in Pediatric Patients With Leg-foot Splint After Surgery for Correction of the Foot, in Reducing the Incidence of Cutaneous Lesions. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Heel Pressure Sores
研究概览
简要总结
The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The problems persist also after placing a polyurethane foam dress at the heel in the immediate postoperative period. The aim of this study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous lesions.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged > 3 years
- •Treated for flat foot
- •Children with intact skin at the heel
排除标准
- •Caregivers who cannot speak Italian
- •Those who refuse to give their consent to take part in the study
- •Patients with lower limb casts
研究组 & 干预措施
cotton sock
干预措施: cotton sock (Other)
Elastic Compression Wraps
干预措施: Elastic Compression Wraps (Other)
结局指标
主要结局
Heel Pressure Sores
时间窗: every day until discharge (expected average of 3 days).
• Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
次要结局
- Pain(up to the first 3 days post intervention)