The Influence of Adhesive Wafer Design on Fit to the Body

Study Overview
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Brief Summary
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The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..

Conditions
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Ostomy - Ileostomy or Colostomy

Intervention / Treatment
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* Device: Test A
* Device: Test B
* Device: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To participate in the study, it is mandatory that the subject fulfill all inclusions 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: Subjects complying with the following criteria must be excluded from participation in the clinical investigation: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test A, Test B, Comparator<br>The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator. | Device: Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator<br>* 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.<br>|
| Experimental: Test A, Comparator, Test B<br>The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B. | Device: Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator<br>* 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.<br>|
| Experimental: Test B, Test A, Comparator<br>The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator. | Device: Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator<br>* 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.<br>|
| Experimental: Test B, Comparator, Test A<br>The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B. | Device: Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator<br>* 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.<br>|
| Experimental: Comparator, Test A, Test B<br>The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B | Device: Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator<br>* 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.<br>|
| Experimental: Comparator, Test B, Test A<br>The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A. | Device: Test A<br>* Test A is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Test B<br>* Test B is a new 1-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit to body | Subjects will evaluate the fit to body for each product by answering the question How was the base plates ability to fit the body contours in the area around the stoma? The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score. | 14 +/- 2 days |