NCT02224404已完成不适用
Open, Non-comparative, Multi-centre Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
Molnlycke Health Care AB8 个研究点 分布在 2 个国家目标入组 21 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
研究概览
简要总结
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Both gender ≥18 years old.
- •Subjects with Stage 2, 3 or 4 cavity pressure ulcer (acc to EPUAP)
- •Exuding pressure ulcer
- •Signed Informed Consent.
排除标准
- •Known allergy/hypersensitivity to the dressing.
- •Infected wounds, (2 signs of infection/local inflammation and a positive swab)
- •Subjects who will have problems following the protocol
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
结局指标
主要结局
Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)
时间窗: 6 weeks
the subjects will be measured by the following variables; maceration,
次要结局
- Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance(6 weeks)
研究者
研究点 (8)
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