Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)
NCT ID: NCT02992444
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2016-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cohort 5
This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 8 hours.
There is one visit:
Two adhesive strips (standard adhesive strip and Experimental adhesive strip)are applied on the peristomal skin and allowed to sit for 8hours before being removed.
Standard adhesive strip
This is a standard adhesive strip (hydrocolloid)
Experimental adhesive strip
This is a strip of a newly developed adhesive.
Interventions
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Standard adhesive strip
This is a standard adhesive strip (hydrocolloid)
Experimental adhesive strip
This is a strip of a newly developed adhesive.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Lene Feldskov, M. Sci
Role: PRINCIPAL_INVESTIGATOR
Senior R&D Scientist
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP265_05
Identifier Type: -
Identifier Source: org_study_id
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