NCT01640418已完成不适用
Prevention of Sacral Pressure Ulcers With Preventive Dressings
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).
研究概览
简要总结
In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?
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
- •Age: ≥18 years
- •Admission in one of the ten high-risk departments of the azM
- •Suspected hospital stay of 5 days or more after admission
- •Braden score 19 or less
排除标准
- •Age: <18 years
- •Pre-existing sacral pressure ulcer
- •Pre-existing trauma to the sacrum
- •Patient is unable to speak Dutch
- •Patients with an inability to give informed consent
- •Patients who are unable to give informed consent within 24h after admission
- •Patients who are unable to give informed consent before surgery
研究组 & 干预措施
Mepilex® Border Sacrum dressings
Experimental
Mepilex® Border Sacrum dressings
干预措施: Mepilex® Border Sacrum dressings (Device)
Standard Care
No Intervention
Standard Care
结局指标
主要结局
To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).
时间窗: 8 weeks
till hospital release, max 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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