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NCT03044275 Clinical Trial

The Influence of Output on Skin Covered by Adhesive With Topfilm

Ileostomy - Stoma Clinical Trial

Official title:
The Influence of Output on Skin Covered by Adhesive With Topfilm

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03044275
Other study ID # CP265_08
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated May 29, 2017
Start date January 16, 2017
Est. completion date May 10, 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 a newly developed adhesive with topfilm and a standard adhesive with a topfilm.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date May 10, 2017
Est. primary completion date May 10, 2017
Accepts healthy volunteers No
Gender All
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

Related Conditions & MeSH terms

Intervention

Other:
• New adhesive strip
This is a newly developed adhesive strip that in the future might be part of an ostomy device
• Standard adhesive strip
This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device

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 (trans epidermal water loss) is measured after removing the adhesive from the skin 6 hours
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