Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

Study Overview
=================
Brief Summary
-----------------
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Official Title
-----------------
An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Device: Coloplast Test product 1
* Device: Coloplast Test product 2
* Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Be able to handle the bags themselves or with help from caregiver Have an ileostomy with a diameter between 15 and 45 mm Have had their ostomy for at least three months Currently use a 1-piece flat standard care product with open bag Negative result of a pregnancy test for women of childbearing age Custom-cut product user Be suitable for participation in the investigation Exclusion Criteria: Use irrigation during the study (flush the stoma with water) Currently receiving or have within the past 2 months received radio- and/or chemotherapy Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area Are pregnant or breastfeeding Participating in other interventional clinical investigations or have previously participated in this investigation Max three days wear time Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1; First Coloplast Test product 1<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 1 are randomised to secondly test either: Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2 | Device: Coloplast Test product 1<br>* Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.<br>Device: Coloplast Test product 2<br>* Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S<br>Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)<br>* Standard Care was the subject usual ostomy appliance and had to be one of the following: Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate<br>|
| Experimental: Treatment 2; First Coloplast Test product 2.<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 2 are randomised to secondly test either: Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1 | Device: Coloplast Test product 1<br>* Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.<br>Device: Coloplast Test product 2<br>* Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S<br>Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)<br>* Standard Care was the subject usual ostomy appliance and had to be one of the following: Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate<br>|
| Experimental: Treatment 3,First Standard care (see below)<br>The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either: Coloplast Test product 1 and thereafter Coloplast Test product 2 Coloplast Test product 2 and thereafter Coloplast Test product 1 | Device: Coloplast Test product 1<br>* Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.<br>Device: Coloplast Test product 2<br>* Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S<br>Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)<br>* Standard Care was the subject usual ostomy appliance and had to be one of the following: Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Leakage | The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S | Up to 14 days per test product |