An Exploratory Study Investigating Adhesive Reaction to Output

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

Study Overview

• Status: Completed
• Conditions: Ileostomy
• Intervention / Treatment: Other: Patch 1; Other: Patch 2; Other: Patch 3; Other: Patch 4; Other: patch 5; Other: Patch 6

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebaek, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Patch 1; Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 2; Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 3; Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip; Other: Patch 4; Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: patch 5; Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 6; Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Experimental: 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	Other: Patch 1; Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 2; Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 3; Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip; Other: Patch 4; Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: patch 5; Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 6; Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Experimental: 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	Other: Patch 1; Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 2; Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 3; Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip; Other: Patch 4; Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: patch 5; Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 6; Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Experimental: 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	Other: Patch 1; Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 2; Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 3; Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip; Other: Patch 4; Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: patch 5; Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 6; Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Experimental: 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	Other: Patch 1; Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 2; Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 3; Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip; Other: Patch 4; Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: patch 5; Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 6; Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Experimental: 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	Other: Patch 1; Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 2; Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 3; Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip; Other: Patch 4; Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: patch 5; Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip; Other: Patch 6; Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remaining adherent area of the adhesive	The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling.	8 hours

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CP261