Evaluation of the Effect of Output on Skin Covered by a New Adhesive
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|ClinicalTrials.gov Identifier: NCT03044288|
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ileostomy - Stoma||Other: New adhesive strip Other: Standard adhesive strip||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of the Effect of Output on Skin Covered by a New Adhesive|
|Actual Study Start Date :||January 23, 2017|
|Actual Primary Completion Date :||February 9, 2017|
|Actual Study Completion Date :||February 9, 2017|
Experimental: Cohort 9
This is a sub-study testing the effect of real output applied under two adhesive strips on the skin.
Standard adhesive strip and a strip with a newly developed adhesive (new adhesive strip)
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.
Other: Standard adhesive strip
this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.
- Trans epidermal water loss [ Time Frame: 6 hours ]The condition of the skin is measure by trans epidermal water loss after removing the adhesive strip.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044288
|Humlebaek, Denmark, 3050|
|Principal Investigator:||Lene F Nielsen, M. Sci||Head of preclinical department|