A Multi-centre, Post CE-mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With High Risk of Category 2 or Above Pressure Ulceration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Erythema ( No/Yes)
研究概览
简要总结
This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular, surgical and orthopaedic medical care in the elderly admission, with a high risk to develop skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this investigation.
The rational for this study is to evaluate the potential for Window in the prevention of pressure ulcers because of its ability to reduce shear and friction forces.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute vascular, surgical, orthopaedic, medical or care of the elderly admission
- •aged 18 years or over
- •have an expected total length of stay of 5 or more days
- •at high risk of PU development due to one or more of the following
- •bedfast/chairfast AND completely immobile/very limited mobility
- •category 1 PU on any pressure area skin site (see appendix G)
- •give their written, informed consent to participate
- •expected to be able to comply with follow-up schedule
排除标准
- •risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm
- •subject has category 2-4 pressure ulcer
- •subject has documented skin disease at time of enrolment, as judged by the investigator
- •known allergy/hypersensitivity to any of the components in the dressing
- •previous enroled in the present study
- •subject included in other ongoing clinical investigation at present, as judged by the investigator
研究组 & 干预措施
Window
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
干预措施: Window (Device)
结局指标
主要结局
Erythema ( No/Yes)
时间窗: 14 days
Total improvement of erythema
次要结局
- Overall Experience of Use of the Dressing(14 days)
- Evaluate the Dressing Shape(14 days)