NCT01966380终止2 期
An Open Randomised, Prospective, Crossover, Proof of Concept (Design Validation) Clinical Investigation to Caompare the Performance and Safety of Wound Dressing(Leia) Compared to and Hydroactive Surgical Dressing on Low to Highly Exuding Wounds
Molnlycke Health Care AB2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Absorption of Wound Exudates.
研究概览
简要总结
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer
- •Male of female, 18 years and above
- •Signed Informed Consent Form
排除标准
- •Pregnancy or lactation
- •Wound size not suitable for the wound dressing size
- •Known allergy/hypersensitivity to any of the components in the dressing
研究组 & 干预措施
Device, dressing
Experimental
Intervention: Device, Leia dressing
干预措施: Leia (Device)
Dressing , device
Active Comparator
Intervention: Device: Hydroactive surgical dressing
干预措施: Leia (Device)
结局指标
主要结局
Absorption of Wound Exudates.
时间窗: 2-3 weeks
Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT
次要结局
未报告次要终点
研究者
研究点 (2)
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