A Pilot Evaluation of Adhesives and How They Are Impacted by Output
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Peel force
研究概览
简要总结
This study investigates the impact of real output on the adhesion of two adhesives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have had an ileostomy for more than one year
- •Have intact skin on the area used in the evaluation
- •Has an ileostomy with a diameter up to (≤) 35 mm
- •Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) -
排除标准
- •Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- •Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- •Participating in other interventional clinical investigations or have previously participated in this evaluation
研究组 & 干预措施
Cohort 3
This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output.
There are two kinds of visits:
Visit 1:
Two adhesive strips (standard adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not.
Visit 2:
Two adhesive strips (new adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not.
Visit 2:
干预措施: Standard adhesive strip (Other)
Cohort 3
This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output.
There are two kinds of visits:
Visit 1:
Two adhesive strips (standard adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not.
Visit 2:
Two adhesive strips (new adhesive strip) are applied on the peristomal skin; one strip is exposed to real output (contained in a sleeve) and the other strip is not.
Visit 2:
干预措施: New adhesive strip (Other)
结局指标
主要结局
Peel force
时间窗: 12 hours
The peel force was measured when the adhesive was removed
次要结局
未报告次要终点