User Assessment of a One-Piece Skin Barrier
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- barrier adhesion
研究概览
简要总结
This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.
详细描述
Design:
This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.
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
- •is at least 18 years of age.
- •has an ileostomy.
- •is at least six weeks postoperative.
- •lives and cares for their stoma independently in the community.
- •currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier.
- •currently uses a drainable pouch.
- •is able to wear a 1-piece flat cut-to-fit 10-55 mm.
- •Has a peristomal skin irritation score of 2 or less.
- •is willing to follow the protocol as demonstrated by signing the informed consent and who in the opinion of the investigator is qualified to participate.
排除标准
- •has a fistula on or near the stoma.
- •has been involved in a study involving stoma care with in the last 30 days.
- •is pregnant or lactating, as determined by interview only.
- •is undergoing chemotherapy, radiation or steroid therapy.
- •has an existing medical condition that would compromise their participation in the study.
结局指标
主要结局
barrier adhesion
时间窗: 10 days
Questionnaire will be provided to subject to assess barrier adhesion.
leakage
时间窗: 10 days
Questionnaire will be provided to subject to assess leakage.
barrier tack
时间窗: 10 days
Questionnaire will be provided to subject to assess barrier tack.
ease of barrier removal
时间窗: 10 days
Questionnaire will be provided to subject to assess ease of barrier removal.
comfort
时间窗: 10 days
Questionnaire will be provided to subject to assess comfort.
次要结局
未报告次要终点