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
2017-09-27
2017-10-17
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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Test of new adhesive strips
On the peristomal skin 4 different patches are applied to the skin (Standard hydrocolloid adhesive patch; LT-2, LT21 and 33-20. There is a bag welded to each patch. Tthe bag contains real output.
The difference between the four patches is that they are made of four different adhesives.
The primary endpoint is measured after 8 hours and 24 hours.
Standard hydrocolloid adhesive patch
This patch is made of a standard hydrocolloid adhesive
LT-2
This patch is made of a new adhesive
LT-21
This patch is made of a new adhesive
33-20
This patch is made of a new adhesive
Interventions
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Standard hydrocolloid adhesive patch
This patch is made of a standard hydrocolloid adhesive
LT-2
This patch is made of a new adhesive
LT-21
This patch is made of a new adhesive
33-20
This patch is made of a new adhesive
Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age and have full legal capacity
* Have had a stoma for more than one year
* Have intact skin on the area used in the evaluation
* Has a stoma with a diameter up to (≤) 35 mm
* Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
Exclusion Criteria
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the peri-stomal- or abdominal area (assessed by investigating scientist)
* Actively participating in other interventional clinical investigations or have previously participated in this investigation.
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
Role: PRINCIPAL_INVESTIGATOR
Head of preclinical department
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP265_21_22
Identifier Type: -
Identifier Source: org_study_id
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