NCT02468154已完成不适用
Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group
研究概览
简要总结
Assess whether by placing a "custom made" splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated by operations to the lower limbs which require immediate plaster casts that include the foot
- •Treated by osteotomy, joint fusion, patella repositioning and fracture fixation
- •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 that are allowed to load the limb
结局指标
主要结局
Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group
时间窗: up to the first 2 days during hospitalization and at cast removal (maximum 30 days).
All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain
次要结局
- Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.(one time at cast removal (expected average of 30 days).)
- Health Staff/Caregiver Interventions(up to the first 2 days during hospitalization)
- Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10(one time at cast removal (expected average of 30 days).)
研究者
研究点 (2)
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