Investigation of a New Stoma Product for People With a Stoma

Study Overview
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Brief Summary
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The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Detailed Description
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Enrolled participant with an ileostomy or colostomy with liquid output were randomized to test either the non-Conformité Européene marked investigational product or one of the five comparators Conformité Européene marked products first and then will be crossed over to receive the opposite intervention. The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days. The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating. The study is now complete.

Official Title
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Investigation of a New Stoma Product for People With a Stoma

Conditions
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Peristomal Skin Complication

Intervention / Treatment
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* Device: Non-Conformité Européene marked product
* Device: Conformité Européene marked competitor products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given informed consent to participate by signing the informed consent signature form. Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale) Currently using a flat product Be at least 18 years of age and have full legal capacity Have had their stoma for at least three months (90 days) Can use a product with a max cut size of 40 mm Has experienced leakage* under the baseplate at least three times within the last 14 days. *leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage) Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area Is able to handle the electronic diary (questionnaire/ photo) themselves. Is able to handle (apply, remove, cut etc.) the product themselves Is willing to not use barrier film or barrier cream during the investigation Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation. Is willing to change the product (1pc) or baseplate (2pc) at least every fourth days. Exclusion Criteria: Is currently receiving or have within the past 60 days received radio-and/or chemotherapy - low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer. Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed. Other systemic steroid treatment (e.g. injection, or tablet) are not allowed. Is breastfeeding Is pregnant (based on pregnancy test -urine) Has known hypersensitivity towards any of the products used in the investigation -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The non-Conformité Européene marked product, a Conformité Européene marked product<br>Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days. | Device: Non-Conformité Européene marked product<br>* New Baseplate is not named at this point<br>Device: Conformité Européene marked competitor products<br>* The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.<br>|
| Experimental: A Conformité Européene marked product, then the non-Conformité Européene marked product<br>Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days. | Device: Non-Conformité Européene marked product<br>* New Baseplate is not named at this point<br>Device: Conformité Européene marked competitor products<br>* The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Max Itching Within a Week at Steady State | Participant were asked to rate their itching around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible peristomal skin itch. The primary outcome measure was done on the Intended to Treat population. Steady state period of the treatment period began after three weeks of product use. | Within a week at steady state | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment | Participants were asked how often they had experienced itchy skin around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: None of the time, A little of the time, Some of the time, A lot of the time, and All of the time. The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as how many percentages are the answers from one category out of a total of 100% (all the answers)?. | past 14 days by end of treatment | 
| Max Pain Within a Week at Steady State | Participant were asked to rate their pain around the ostomy on a scale of 0-10 with 0= no pain ad 10= worst possible pain. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment | Participants were asked how often they had experienced pain around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: None of the time, A little of the time, Some of the time, A lot of the time, and All of the time. The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as how many percentages are the answers from one category out of a total of 100% (all the answers)?. | past 14 days by end of treatment | 
| Max Burning Within a Week at Steady State | Participant were asked to rate burning around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible burning sensation. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment | Participants were asked how often they had experienced a burning sensation around their ostomy in the past 14 days by the end of treatment. The data was distributed into five categories: None of the time, A little of the time, Some of the time, A lot of the time, and All of the time. The results are shown as the percentages of answers for that category out of a total of a 100% (comprising the total of all answers from all the categories). When adding the number for each of the five categories it sums up to 100. So the results are shown as how many percentages are the answers from one category out of a total of 100% (all the answers)?. | past 14 days by end of treatment | 
| Bleeding Around the Ostomy at Each Baseplate Change at Steady State | Participant were asked if they had experienced bleeding around the ostomy within 1 week. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Weeping Around the Ostomy at Each Baseplate Change at Steady State | Participant were asked if they had experienced weeping around the ostomy within 1 week. Steady state period of the treatment period begins after three weeks of product use. | Within one week at steady state | 
| Ulcers Around the Ostomy at Each Baseplate Change at Steady State | Participant were asked if they had experienced ulcers around the ostomy within 1 week. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Max Overall Physical Discomfort Within a Week Per Baseplate Change at Steady State | Participant were asked to rate their overall physical discomfort around the ostomy on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Max Overall Ability to Move Around Within a Week Per Baseplate Change at Steady State | Participant were asked to rate their overall ability to move around on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Max Overall Ability to Stick the Stoma Bag Adhesive to the Skin Within a Week Per Baseplate Change at Steady State | Participant were asked to rate the overall ability to stick the stoma bag adhesive to their skin since last change of product on a scale of 0-10 with 0= no discomfort/difficulty and 10= a lot of discomfort/difficulty. Steady state period of the treatment period began after three weeks of product use. | Within one week at steady state | 
| Discoloration Area (cm^2) Per Baseplate Change at Steady State | Participant were asked to take photos of their peristomal skin at each baseplate change. The discoloration area of the peristomal skin was determined using an algorithm. The algorithm estimated the area of the discolored skin (divided into three different zones). Steady state period of the treatment period began after three weeks of product use. | 3 weeks | 
| Intensity of Discolorated Area Scored Per Baseplate Change at Steady State After Three Weeks of Product Use | Photos of the peristomal skin was taken at each baseplate change. The intensity was determined with an overlay to the artificial intelligence algorithm. The overlay divided the area into ten different intensity intervals: Intensity interval 1=0-10 …., Intensity interval 10=91-100% redness. The score was then calculated as follows: 1*(Interval 1 measurement)..+ 10*(Interval 10 measurement). Thus, if the area was within the first interval (0-10% redness) it was multiplied with 1 or within Interval 10 it was multiplied with 10, resulting in a intensity score for the total area. If there is no discoloration the score is 0, and there is no theoretical maximum. A large score equals a high intensity on the skin. In the description of the endpoint (appendix. 1 in CIP), it was to be determined in the inner and outer zone per baseplate change at steady state. However, the algorithm only estimated a total intensity score; thus, the intensity will not be reported per inner and outer zone. | 3 weeks | 
| Total Discoloration, Erosion, and Tissue Overgrowth (DET) Score by End of Treatment at Steady State | Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. They determined the discoloration, erosion, and tissue overgrowth domain by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected by each domain. Each three domains contributes to the calculation of the total Discoloration, Erosion and Tissue overgrowth score (DET) going from a scale of 0 to 15 (Normal skin (DET=0), Mild (DET=2- 3), Moderate (DET=4- 6), and Severe (7-15)). Steady state period of the treatment period began after three weeks of product use. | 3 weeks | 
| Discoloration Item Score by End of Treatment at Steady State | Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Discoloration is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15. The discoloration domain was scored by area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and the scores were added together for a total discoloration score (with the max total score being 5). The area is assessed first and if this is 0 then the score for discoloration is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more discolored skin. Steady state period of the treatment period began after three weeks of product use | 3 weeks | 
| Erosion Item Score by End of Treatment at Steady State | Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Erosion is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15.The erosion domain was determined by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and then adding the scores together for a total score (with the max total score being 5). The area is assessed first and if this is 0 then the score for erosion is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more eroded skin. Steady state period of the treatment period began after three weeks of product use. | 3 weeks | 
| Tissue Overgrowth Item Score by End of Treatment at Steady State | Participant were asked to take photos close to the stoma, which was then assessed by a sponsor or health care professionals. Tissue overgrowth is a part of the discoloration, erosion, and tissue overgrowth (DET) score where all domains are assess to give a total DET score, with a min of 0 and max of 15. The Tissue Overgrowth domain was assessed by scoring the area (0-3, with 3 being a large area affected), and severity (1-2, with 2 being the highest severity) affected and then adding the scores together for a total score (with the max total score being 5). The area is assessed first and if this is 0 then the score for tissue overgrowth is 0, meaning the severity is not assessed. This means that the maximum score possible is 5 and the lowest score possible is 0 and the higher the score the more tissue overgrowth. Steady state period of the treatment period began after three weeks of product use. | 3 weeks |