Evaluation of the Influence of New Adhesives of Output on Skin
NCT ID: NCT03044262
Last Updated: 2017-05-31
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
15 participants
INTERVENTIONAL
2017-01-09
2017-04-25
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 7
This is a sub-study testing the effect of real output applied under two adhesive strips (standard adhesive strip and new adhesive strip) on the skin after 8 hours.
Standard adhesive strip
This is a standard adhesive strip (hydrocolloid) that is part of an ostomy device
New adhesive strip
This is a newly developed adhesive strip that in the future might be part of an ostomy device
Interventions
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Standard adhesive strip
This is a standard adhesive strip (hydrocolloid) that is part of an ostomy device
New adhesive strip
This is a newly developed adhesive strip that in the future might be part of an ostomy device
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
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_07
Identifier Type: -
Identifier Source: org_study_id
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