Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 9
- 主要终点
- Rate of any type of pressure ulcer in the sacral area.
研究概览
简要总结
The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at risk to develop Pressure Ulcer (Braden scale <17)
- •without sacrum Pressure Ulcer
- •Patients or legal guardians who give their consent to take part in the study
排除标准
- •Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
研究组 & 干预措施
Hydrocellular polyurethane foam multilayer dressing
干预措施: Hydrocellular polyurethane foam multilayer dressing (Device)
Hydrocellular polyurethane foam multilayer dressing
干预措施: Standard preventive care (Procedure)
standard preventive care
干预措施: Standard preventive care (Procedure)
结局指标
主要结局
Rate of any type of pressure ulcer in the sacral area.
时间窗: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
The ulcer will be classified according to the National Pressure Ulcers Advisory Panel Classification. Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).
次要结局
- Pressure Ulcer Rate in the Sacral Area of Category≥ II(On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)
- Skin irritation/damage due to the adhesive dressing(On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)
- Number of dressing used per patient.(On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)