NCT00626821已完成4 期
An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,017
- 试验地点
- 2
- 主要终点
- Quality of Life (Scale 0(Worst)-100(Best))
研究概览
简要总结
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
详细描述
It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quality of Life (Scale 0(Worst)-100(Best))
时间窗: 6-8 weeks
The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.
次要结局
未报告次要终点
研究者
研究点 (2)
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