An Exploratory Study Investigating Adhesive Reaction to Output

Not Applicable

Completed

• Conditions: Ileostomy
• Interventions: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6

• Registration Number: NCT02594085
• Lead Sponsor: Coloplast A/S

Brief Summary

The objective is to investigate the impact that faecal output has on adhesives.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than 3 months
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter (≤) 35mm

Exclusion Criteria

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal area
5. Convex user
6. Participate in other interventional clinical investigations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6	Patch 1	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
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6	patch 5	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
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6	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
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4	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
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4	Patch 1	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
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4	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 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6	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 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4	Patch 1	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
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4	patch 5	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
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2	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
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6	Patch 3	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
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6	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 1 and Patch 2 Test period 3: Patch 5 and Patch 6
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6	Patch 1	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
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6	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 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6
Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6	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
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6	Patch 3	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
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6	patch 5	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
Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6	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
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4	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 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4	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
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4	patch 5	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
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2	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 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4	Patch 3	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
Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4	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
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4	Patch 3	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
Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4	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 5 and Patch 6 Test period 3: Patch 1 and Patch 2
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2	Patch 3	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
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4	patch 5	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
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4	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
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2	Patch 1	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
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4	Patch 1	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
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2	patch 5	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
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4	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 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4	Patch 3	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
Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2	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 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2
Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4	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

Primary Outcome Measures

Name	Time	Method
Remaining adherent area of the adhesive	8 hours	The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark