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NCT03044288 Clinical Trial

Evaluation of the Effect of Output on Skin Covered by a New Adhesive

Ileostomy - Stoma Clinical Trial

Official title:
Evaluation of the Effect of Output on Skin Covered by a New Adhesive

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03044288
Other study ID # CP265_09
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated May 29, 2017
Start date January 23, 2017
Est. completion date February 9, 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 and a standard adhesive

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date February 9, 2017
Est. primary completion date February 9, 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 strip made of a newly developed adhesive. This adhesive might in the future be part of an ostomy product.
• Standard adhesive strip
this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.

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 is measure by trans epidermal water loss after removing the adhesive strip. 6 hours
See also
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