The Influence of Adhesive Wafer Design on Fit to the Body
NCT ID: NCT02176954
Last Updated: 2015-03-23
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
40 participants
INTERVENTIONAL
2014-07-31
2015-03-31
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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Test A, Test B, Comparator
The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator.
Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Test A, Comparator, Test B
The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B.
Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Test B, Test A, Comparator
The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator.
Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Test B, Comparator, Test A
The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B.
Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Comparator, Test A, Test B
The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B
Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Comparator, Test B, Test A
The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A.
Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Interventions
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Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Comparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Eligibility Criteria
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Inclusion Criteria
* Have given written informed consent and signed letter of Authority
* Be at least 18 years of age and have full legal capacity
* Have had their ileostomy or colostomy for at least 3 months
* Have a stoma with a diameter between 15 and 43 mm
* Be able to handle the product themselves
* Be able to use a custom cut product
* Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
* Currently using a 1-piece flat product or a 1-piece soft convex product
* Be willing to test products with open bag size maxi
* Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
* Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
* Be suitable for participating in the investigation
* Be willing to take/have taken pictures of the stoma before, during and after application of product
Exclusion Criteria
* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
* Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestines with water)
* Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
* Have a loop stoma
* Have known hypersensitivity towards 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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Khalid Abd-Elaziz, MD
Role: PRINCIPAL_INVESTIGATOR
QPS Netherlands
Susanne Eyre, MD
Role: PRINCIPAL_INVESTIGATOR
Synexus North East, United Kingdom
Gillian Hopkins
Role: PRINCIPAL_INVESTIGATOR
Cheltenham General Hospital, United Kingdom
Locations
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QPS Netherlands
Groningen, , Netherlands
Synexus Thames Valley
Berkshire, , United Kingdom
Synexus Midlands
Birmingham, , United Kingdom
Synexus Wales
Cardiff, , United Kingdom
Synexus Scotland
Glasgow, , United Kingdom
Cheltenham General Hospital
Gloucestershire, , United Kingdom
Synesxus Lancashire
Lancashire, , United Kingdom
Synexus Merseyside
Liverpool, , United Kingdom
Synexus Manchester
Manchester, , United Kingdom
Synexus North East
Northumberland, , United Kingdom
Countries
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Other Identifiers
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CP247
Identifier Type: -
Identifier Source: org_study_id
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