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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Degree of Leakage
研究概览
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •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)
研究组 & 干预措施
Treatment 1; First Coloplast Test product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test either:
- Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2
干预措施: Coloplast Test product 1 (Device)
Treatment 1; First Coloplast Test product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test either:
- Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2
干预措施: Coloplast Test product 2 (Device)
Treatment 1; First Coloplast Test product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 1 are randomised to secondly test either:
- Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2
干预措施: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) (Device)
Treatment 2; First Coloplast Test product 2.
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test either:
- Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1
干预措施: Coloplast Test product 1 (Device)
Treatment 2; First Coloplast Test product 2.
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test either:
- Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1
干预措施: Coloplast Test product 2 (Device)
Treatment 2; First Coloplast Test product 2.
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Coloplast Test product 2 are randomised to secondly test either:
- Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1
干预措施: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) (Device)
Treatment 3,First Standard care (see below)
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either:
- Coloplast Test product 1 and thereafter Coloplast Test product 2
- Coloplast Test product 2 and thereafter Coloplast Test product 1
干预措施: Coloplast Test product 1 (Device)
Treatment 3,First Standard care (see below)
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either:
- Coloplast Test product 1 and thereafter Coloplast Test product 2
- Coloplast Test product 2 and thereafter Coloplast Test product 1
干预措施: Coloplast Test product 2 (Device)
Treatment 3,First Standard care (see below)
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either:
- Coloplast Test product 1 and thereafter Coloplast Test product 2
- Coloplast Test product 2 and thereafter Coloplast Test product 1
干预措施: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) (Device)
结局指标
主要结局
Degree of Leakage
时间窗: Up to 14 days per test product
The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S
次要结局
未报告次要终点