The Influence of Baseplate Adhesive on the Degree of Leakage
NCT ID: NCT01995357
Last Updated: 2015-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2013-10-31
2013-12-31
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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First Coloplast Teast A; then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
First Coloplast Test A; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
First Coloplast Test B; Then Colopast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
First Coloplast Test B; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
First Standard product; Then Coloplast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
First Standard Product, Then Coloplast test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Interventions
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Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Eligibility Criteria
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Inclusion Criteria
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy/colostomy for at least 3 months
4. Have a stoma with a diameter between 15 and 36 mm
5. Be able to handle the products themselves
6. Be able to use a custom cut product
7. Normally experience faeces under the base plate at least 3 times during 2 weeks
8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
9. Be willing to test the test products without using paste and/or ring
10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
11. Be suitable for participation in the investigation
12. Be able to present a negative result of a pregnancy test - for women of childbearing age
Exclusion Criteria
2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Use irrigation during the investigation (flush the intestines with water)
6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
7. Have a loop stoma
8. Have known hypersensitivity towards any of the test products (including adhesive remover)
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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CP244
Identifier Type: -
Identifier Source: org_study_id
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