An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

Coloplast A/S1 个研究点分布在 1 个国家目标入组 25 人2012年2月

适应症Ileostomy - Stoma

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Ileostomy - Stoma
发起方: Coloplast A/S
入组人数: 25
试验地点: 1
主要终点: Degree of Leakage
状态: 已完成
最后更新: 12年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

注册库

clinicaltrials.gov

开始日期

2012年2月

结束日期

2012年5月

最后更新

12年前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Coloplast A/S

责任方

Sponsor

入排标准

入选标准

•Have given written informed consent
•Be at least 18 years of age and have full legal capacity
•Be able to handle the bags themselves or with help from caregiver
•Have an ileostomy with a diameter between 15 and 45 mm
•Have had their ostomy for at least three months
•Currently use a 1-piece flat standard care product with open bag
•Negative result of a pregnancy test for women of childbearing age
•Custom-cut product user
•Be suitable for participation in the investigation

排除标准

•Use irrigation during the study (flush the stoma with water)
•Currently receiving or have within the past 2 months received radio- and/or chemotherapy
•Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
•Are pregnant or breastfeeding
•Participating in other interventional clinical investigations or have previously participated in this investigation
•Max three days wear time
•Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)