An Exploratory Study Investigating Adhesive Reaction to Output
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Remaining adherent area of the adhesive
研究概览
简要总结
The objective is to investigate the impact that faecal output has on adhesives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 3 months
- •Have intact skin on the area used in the evaluation
- •Has an ileostomy with a diameter (≤) 35mm
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 area
- •Convex user
- •Participate in other interventional clinical investigations
研究组 & 干预措施
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
干预措施: Patch 1 (Other)
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
干预措施: Patch 2 (Other)
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
干预措施: Patch 3 (Other)
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
干预措施: Patch 4 (Other)
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
干预措施: patch 5 (Other)
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
干预措施: Patch 6 (Other)
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 1 (Other)
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 2 (Other)
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 3 (Other)
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 4 (Other)
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: patch 5 (Other)
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 6 (Other)
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 1 (Other)
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 2 (Other)
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 3 (Other)
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 4 (Other)
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: patch 5 (Other)
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 6 (Other)
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
干预措施: Patch 1 (Other)
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
干预措施: Patch 2 (Other)
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
干预措施: Patch 3 (Other)
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
干预措施: Patch 4 (Other)
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
干预措施: patch 5 (Other)
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
干预措施: Patch 6 (Other)
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
干预措施: Patch 1 (Other)
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
干预措施: Patch 2 (Other)
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
干预措施: Patch 3 (Other)
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
干预措施: Patch 4 (Other)
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
干预措施: patch 5 (Other)
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
干预措施: Patch 6 (Other)
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 1 (Other)
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 2 (Other)
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 3 (Other)
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 4 (Other)
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: patch 5 (Other)
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4
The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods.
In this arm the the subjects test:
Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
干预措施: Patch 6 (Other)
结局指标
主要结局
Remaining adherent area of the adhesive
时间窗: 8 hours
The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.
次要结局
未报告次要终点