Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 2
- 主要终点
- Number of Participants With Pressure Sores
研究概览
简要总结
The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU
- •Patients or legal guardians who give their consent to take part in the study
- •Exclusion Criteria
- •Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
- •Patients with peri-prosthetic or pathological fractures
- •Patients with diaphyseal or distal femoral fractures
排除标准
- 未提供
研究组 & 干预措施
polyurethane foam
Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area
干预措施: hydrocellular polyurethane foam multilayer dressing (Device)
polyurethane foam
Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area
干预措施: standard care (Procedure)
standard care
干预措施: standard care (Procedure)
结局指标
主要结局
Number of Participants With Pressure Sores
时间窗: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
次要结局
- Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing(On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.)
- Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification(On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.)
- Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)(On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.)