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NCT03000881 Clinical Trial

Evaluation of the Influence of Output on Skin Covered by Adhesives

Ileostomy - Stoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03000881
Other study ID # CP265_06
Secondary ID
Status Completed
Phase N/A
First received December 20, 2016
Last updated May 29, 2017
Start date December 2016
Est. completion date April 4, 2017

Study information
Verified date May 2017
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigates the impact real output has on peristomal skin covered by two different adhesives

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date April 4, 2017
Est. primary completion date April 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have given written informed consent

- Be at least 18 years of age and have full legal capacity

- Have had an ileostomy for more than one year

- Have intact skin on the area used in the evaluation

- Has an ileostomy with a diameter up to 35 mm

- Have a peristomal area accessible for application of adhesive strips

Exclusion Criteria:

- 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- or abdominal area (assessed by investigating scientist)

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• standard adhesive
This is a standard adhesive (hydrocolloid)
• New adhesive strip
This is 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 8 hours
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