Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 15
- 主要终点
- Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
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.
Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.
The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •At risk of pressure ulcer development based on a Braden score ≤ 17
- •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
- •Pressure ulcer Cat. II+ present on initial evaluation
结局指标
主要结局
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
时间窗: 30 days
Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices
次要结局
- Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)(30 days)
- Comfort of participants (self developed questionnaire)(30 days)