Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
NCT ID: NCT02886455
Last Updated: 2016-10-13
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
4 participants
INTERVENTIONAL
2016-09-30
2016-09-30
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 4
This is a sub-study testing the effect of real output applied under two adhesive strips on the skin at two different time points (4 and 24 hours).
There are two visits:
Visit 1:
Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 4 hours before being removed
Visit 2: Two adhesive strips (standard adhesive strip and new adhesive strip)contaminated with the subjects own output are applied on the peristomal skin and allowed to sit for 24 hours before being removed
Standard adhesive strip
This is a standard adhesive strip (hydrocolloid)
New adhesive strip
This a newly developed adhesive strip.
Interventions
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Standard adhesive strip
This is a standard adhesive strip (hydrocolloid)
New adhesive strip
This a newly developed adhesive strip.
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 F Nielsen, Msc
Role: PRINCIPAL_INVESTIGATOR
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_04
Identifier Type: -
Identifier Source: org_study_id
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