NCT01526967Unknown不适用
Observational Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™ Skin Barriers
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 13
- 主要终点
- Peristomal skin condition
研究概览
简要总结
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.
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 a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.
- •Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.
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
Peristomal skin condition
时间窗: At day 12
Change in peristomal skin condition from baseline as assessed with the SACS Instrument
次要结局
- Peristomal Skin Condition(At 2 months)
- Peristomal skin condition(at 1 month)
- Level of satisfaction(At 1 month)
- Accessory usage(Up to 2 months)
研究者
研究点 (13)
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