跳至主要内容
临床试验/NCT03000881
NCT03000881已完成不适用

Evaluation of the Influence of Output on Skin Covered by Adhesives

Coloplast A/S2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Coloplast A/S
入组人数
15
试验地点
2
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 two different 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

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 adhesive strips

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 -

结局指标

主要结局

Trans Epidermal Water Loss

时间窗: 8 hours

次要结局

未报告次要终点

研究者

发起方
Coloplast A/S
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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