Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.

Official Title
-----------------
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

Conditions
-----------------
Ileostomy, Colostomy

Intervention / Treatment
-----------------
* Device: Coloplast Test Product
* Device: Comparator (Hollister)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent and in DK: signed a 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 Able to use a baseplate size 15 to 40 mm Be able to handle the product themselves Normally experience faeces under the baseplate at least 3 times during 2 weeks Currently using a 2-piece flat product with mechanical coupling Willing to test both the Coloplast test product and the comparator product Willing to use an open bag size maxi during the investigation Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt) Willing to use at least 1 baseplate every 3rd day during the investigation Is able to use a custom cut product Be suitable for participating in the investigation Exclusion Criteria: Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer) Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed 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) Have a loop ostomy Have known hypersensitivity towards any of the products used in the investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Coloplast Test Product then Comparator<br>The subject first tests the Coloplast Test Product and then tests the Comparator | Device: Coloplast Test Product<br>* A new 2-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator (Hollister)<br>* Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.<br>|
| Experimental: Comparator then Coloplast Test Product<br>The subject first tests the Comparator and then tests the Coloplast Test Product. | Device: Coloplast Test Product<br>* A new 2-piece ostomy appliance developed by Coloplast A/S<br>Device: Comparator (Hollister)<br>* Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good. | 21 +/- 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ostomy