Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
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
- Trans epidermal water loss
研究概览
简要总结
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.
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 4
This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours).
There are two visits:
Visit 1:
Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed
Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed
干预措施: Standard adhesive strip (Other)
Cohort 4
This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours).
There are two visits:
Visit 1:
Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed
Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed
干预措施: New adhesive strip (Other)
结局指标
主要结局
Trans epidermal water loss
时间窗: 4-24 hours
The condition of the skin (transepidermal water loss) is measured after removing the adhesive by TE
次要结局
未报告次要终点