The Influence of Baseplate Adhesive on the Degree of Leakage

Study Overview
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Brief Summary
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The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Official Title
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The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy

Conditions
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Colostomy Stoma, Ileostomy Stoma

Intervention / Treatment
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* Device: Coloplast Test A
* Device: Coloplast Test B
* Device: Standard product


Participation Criteria
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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/colostomy for at least 3 months Have a stoma with a diameter between 15 and 36 mm Be able to handle the products themselves Be able to use a custom cut product Normally experience faeces under the base plate at least 3 times during 2 weeks 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 Be willing to test the test products without using paste and/or ring Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct Be suitable for participation in the investigation Be able to present a negative result of a pregnancy test - for women of childbearing age 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 local or systemic steroid treatment in the peristomal area 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 peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative) Have a loop stoma Have known hypersensitivity towards any of the test products (including adhesive remover)

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: First Coloplast Teast A; then Coloplast Test B<br>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 | Device: Coloplast Test A<br>* Coloplast Test A is a newly developed ostomy appliance<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance.<br>Device: Standard product<br>* 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.<br>|
| Experimental: First Coloplast Test A; Then Standard product<br>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 | Device: Coloplast Test A<br>* Coloplast Test A is a newly developed ostomy appliance<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance.<br>Device: Standard product<br>* 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.<br>|
| Experimental: First Coloplast Test B; Then Colopast Test A<br>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 | Device: Coloplast Test A<br>* Coloplast Test A is a newly developed ostomy appliance<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance.<br>Device: Standard product<br>* 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.<br>|
| Experimental: First Coloplast Test B; Then Standard product<br>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 | Device: Coloplast Test A<br>* Coloplast Test A is a newly developed ostomy appliance<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance.<br>Device: Standard product<br>* 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.<br>|
| Experimental: First Standard product; Then Coloplast Test A<br>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 | Device: Coloplast Test A<br>* Coloplast Test A is a newly developed ostomy appliance<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance.<br>Device: Standard product<br>* 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.<br>|
| Experimental: First Standard Product, Then Coloplast test B<br>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 | Device: Coloplast Test A<br>* Coloplast Test A is a newly developed ostomy appliance<br>Device: Coloplast Test B<br>* Coloplast Test B is a newly developed ostomy appliance.<br>Device: Standard product<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Leakage | The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group. | 10 (- 2 days) |