NCT01354899已完成不适用
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 a High Risk of Skin Breakdown
Molnlycke Health Care AB1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Erythema (No/Yes)
研究概览
简要总结
The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay, an expected average of 5 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Provision of written informed consent
- •Braden total score ≤ 12 at enrolment
- •Male or female, ≥ 18 at enrolment
- •No skin- breakdown
- •Subject or family member is able to understand and comply with the requirements of the study, judged by the investigator
排除标准
- •Risk area dosen´t fit the dressing size
- •Documented skin disease
- •Kown allergy to any of the components in the dressing
- •Previous enroled in present study
- •Subject included in other ongoing clinical investigation
结局指标
主要结局
Erythema (No/Yes)
时间窗: During 5 days
Measure number of skin breakdown during from enrolment to termination.
次要结局
- Overall Experience of Use of the Dressing(During 5 days)
研究者
研究点 (1)
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