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
6 participants
INTERVENTIONAL
2017-07-19
2017-09-13
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 three new adhesive strips
The subjects test three new adhesive strips
* adhesive strip A
* adhesive strip B
* adhesive strip C
Adhesive strip A
Strip consisting of a newly developed adhesive
Adhesive strip B
Strip consisting of a newly developed adhesive
Adhesive strip C
Strip consisting of a newly developed adhesive
Interventions
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Adhesive strip A
Strip consisting of a newly developed adhesive
Adhesive strip B
Strip consisting of a newly developed adhesive
Adhesive strip C
Strip consisting 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 a stoma for more than one year
4. Have intact skin on the area used in the evalua-tion
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of 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 peristo-mal- or abdominal area (assessed by investigating scientist)
5. 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 F Nielsen
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_12_13_14
Identifier Type: -
Identifier Source: org_study_id