Status:
COMPLETED
Investigation of a New Stoma Product for People With a Stoma
Lead Sponsor:
Coloplast A/S
Conditions:
Peristomal Skin Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 subje...
Detailed Description
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 Conform...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
January 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2020
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04101318
Start Date
January 22 2020
End Date
July 17 2020
Last Update
September 21 2023
Active Locations (1)
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1
Ragene Saetre
Larvik, Norway, 3256