Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Ability to maintain secure (snug) fit around stoma
研究概览
简要总结
A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.
Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.
详细描述
Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
- •Able to participate for four weeks.
排除标准
- •Needing convexity.
结局指标
主要结局
Ability to maintain secure (snug) fit around stoma
时间窗: Two weeks
1. Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks 2. Barrier gap assessment performed by nurse at 2 weeks 3. Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks
次要结局
- Ease of use(Two weeks)
- Ease of teaching(Two weeks)
- Comfort(Two weeks)
- Skin Protection(Two weeks)
- Wear Time(Two weeks)