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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03044288
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Other: New adhesive strip Other: Standard adhesive strip Not Applicable

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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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03044288

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Coloplast A/S
Humlebaek, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
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Principal Investigator: Lene F Nielsen, M. Sci Head of preclinical department

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Responsible Party: Coloplast A/S Identifier: NCT03044288    
Other Study ID Numbers: CP265_09
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No