A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
NCT ID: NCT02610907
Last Updated: 2016-01-20
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
2015-11-30
2016-01-31
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 01a
This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions:
Buffer Own output Simulated output (digestive enzymes)
All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
Buffer
The sleeve contains phosphate buffered saline buffer
Own output
The sleeve contains the subject own ileal effluent
simulated output
The sleeve contains simulated output
Interventions
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Buffer
The sleeve contains phosphate buffered saline buffer
Own output
The sleeve contains the subject own ileal effluent
simulated output
The sleeve contains simulated output
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 Principal Scientist
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP265_01
Identifier Type: -
Identifier Source: org_study_id
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