Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
NCT ID: NCT01957397
Last Updated: 2016-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2012-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Coloplast Test 1
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2
Finally the all subject test Coloplast Test 3
Coloplast Test 1
Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2
Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3
Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1
Finally the all subject test Coloplast Test 3
Coloplast Test 1
Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2
Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3
Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
Interventions
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Coloplast Test 1
Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 2
Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
Coloplast Test 3
Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
Eligibility Criteria
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Inclusion Criteria
1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months.
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33mm or less
6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks
Exclusion Criteria
1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant\* or breastfeeding.
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
6. Known hypersensitivity toward any of the test products
\-
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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Birte P Jakobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Coloplast A/S
Locations
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Coloplast A/S
Humlebæk, , Denmark
Countries
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Other Identifiers
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CP230
Identifier Type: -
Identifier Source: org_study_id
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