A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
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
- Remaining adhesive area of adhesive
研究概览
简要总结
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of 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 01a
This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions:
Buffer Own output Simulated output (digestive enzymes)
All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
干预措施: Buffer (Other)
Cohort 01a
This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions:
Buffer Own output Simulated output (digestive enzymes)
All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
干预措施: Own output (Other)
Cohort 01a
This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions:
Buffer Own output Simulated output (digestive enzymes)
All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
干预措施: simulated output (Other)
结局指标
主要结局
Remaining adhesive area of adhesive
时间窗: 30 hours
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.
次要结局
未报告次要终点