Evaluation of the Influence of Output on Skin Wearing a New Adhesive
|ClinicalTrials.gov Identifier: NCT03200431|
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ileostomy - Stoma||Other: New 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 Influence of Output in Skin Covered by Newly Developed Adhesives|
|Actual Study Start Date :||June 26, 2017|
|Actual Primary Completion Date :||December 11, 2017|
|Actual Study Completion Date :||December 11, 2017|
Experimental: Test of a new adhesive strip
This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 24 hours. The adhesive strip is not yet part of a marketed ostomy device.
Other: New adhesive strip
This is a newly developed strip.
- Trans epidermal water loss [ Time Frame: 24 hours ]The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200431
|Humlebæk, Denmark, 3050|