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临床试验/NCT02992444
NCT02992444已完成不适用

Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)

Coloplast A/S2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年12月1日最近更新:
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
5
试验地点
2
主要终点
Trans epidermal water loss

研究概览

简要总结

This study investigates the impact real output has on peristomal skin covered by an 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

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

结局指标

主要结局

Trans epidermal water loss

时间窗: 4 - 24 hours

The skins barrier function is measured using trans epidermal water loss after removing the adhesive from the skin

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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