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The Influence of Output on Skin Covered by Adhesive With Topfilm

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ClinicalTrials.gov Identifier: NCT03044275
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Output on Skin Covered by Adhesive With Topfilm
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 10, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 8

This is a sub-study testing the effect of real output on the skin applied under two adhesive strips.

New adhesive strip Standard adhesive strip

 Other: New adhesive strip
This is a newly developed adhesive strip that in the future might be part of an ostomy device

Other: Standard adhesive strip
This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device


Outcome Measures
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Primary Outcome Measures :
  1. Trans epidermal water loss [ Time Frame: 6 hours ]
    the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin


Eligibility Criteria
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Information from the National Library of Medicine

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

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 -
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03044275


Locations
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Denmark
Coloplast A/S
Humlebaek, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Lene Feldskov, M. Sci Head of preclinical department
More Information
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT03044275    
Other Study ID Numbers: CP265_08
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