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NCT02886455 Clinical Trial

Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives

Ileostomy - Stoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02886455
Other study ID # CP265_04
Secondary ID
Status Completed
Phase N/A
First received August 29, 2016
Last updated October 12, 2016
Start date September 2016
Est. completion date September 2016

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

Clinical Trial Summary

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date September 2016
Est. primary completion date September 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 one year

4. Have intact skin on the area used in the evaluation

5. Has an ileostomy with a diameter up to (=) 35 mm

6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

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- or abdominal area (assessed by investigating scientist)

5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• Standard adhesive strip
This is a standard adhesive strip (hydrocolloid)
• New adhesive strip
This a newly developed 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 Trans epidermal water loss The condition of the skin (transepidermal water loss) is measured after removing the adhesive by TE 4-24 hours No
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