NCT02499588Unknown不适用
Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Peri-stomal skin condition at 8-15 days following the application of the barrier.
研究概览
简要总结
The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subjects who are 18 years old and older.
- •Subjects who agree to participate in the evaluation and who have signed the informed consent form.
- •Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
- •Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).
排除标准
- •Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
- •Subjects who are in a simultaneous clinical evaluation.
结局指标
主要结局
Peri-stomal skin condition at 8-15 days following the application of the barrier.
时间窗: 8-15 days
Using SACs scale to determine incidence and severity of lesions
次要结局
- Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.(1 month (± 15 days))
- Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.(2 months (± 15 days))
研究者
研究点 (1)
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