The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pressure ulcer healing
研究概览
简要总结
Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.
It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
- •Bedbound or chair bound
- •Aged ≥ 65
排除标准
- •Short-stay residents (expected length of stay ≤14 days)
- •End of life care
- •Medical contraindication for patient repositioning/turning
研究组 & 干预措施
22 residentsat risk for PU development
22 residents at risk for PU development, defined by a Braden score < 12 and/or a Braden subscale 'Mobility' score ≤ 2 and/or the presence of non-blanchable erythema in the sacral area.
aged 65 years or over
干预措施: 22 residentsat risk for PU development (Device)
18 residents at least one PU category III-IV in the sacral area
18 residents at least one PU category III-IV in the sacral area aged 65 years or over
干预措施: 18 residents at least one PU category III-IV in the sacral area (Device)
结局指标
主要结局
Pressure ulcer healing
时间窗: 30 days
Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)
Pressure ulcer incidence
时间窗: 30 days
Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
次要结局
- Comfort(30 days)