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NCT02594085 Clinical Trial

An Exploratory Study Investigating Adhesive Reaction to Output

Ileostomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02594085
Other study ID # CP261
Secondary ID
Status Completed
Phase N/A
First received October 30, 2015
Last updated January 19, 2016
Start date October 2015
Est. completion date January 2016

Study information
Verified date January 2016
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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
• 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
• 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
• 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
• 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
• 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

Locations
Country Name City State
Denmark Coloplast A/S Humlebaek

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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