N/A
N=72
Investigation of a New Stoma Product for People With a Stoma
Peristomal Skin Complication
Bottom Line
View on ClinicalTrials.gov: NCT04101318 ↗Enrolled (actual)
72
Serious AEs
2.2%
Results posted
Sep 2023
Primary outcome: Primary: Max Itching Within a Week at Steady State — 2.5; 2.4 score on a scale — p=0.625
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-Conformité Européene marked product (Device); Conformité Européene marked competitor products (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Max Itching Within a Week at Steady State |
2.5; 2.4 | 0.625 |
| SECONDARY Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment |
22; 22; 37; 22; 25; 29 | 0.036 sig |
| SECONDARY Max Pain Within a Week at Steady State |
1.4; 1.7 | 0.202 |
| SECONDARY Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment |
45; 43; 39; 33; 10; 20 | 0.267 |
| SECONDARY Max Burning Within a Week at Steady State |
1.8; 2.0 | 0.545 |
| SECONDARY Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment |
37; 39; 39; 27; 16; 22 | 0.293 |
| SECONDARY Bleeding Around the Ostomy at Each Baseplate Change at Steady State |
0.38; 0.46 | 0.375 |
| SECONDARY Weeping Around the Ostomy at Each Baseplate Change at Steady State |
0.38; 0.46 | 0.482 |
| SECONDARY Ulcers Around the Ostomy at Each Baseplate Change at Steady State |
0.40; 0.57 | 0.151 |
| SECONDARY Max Overall Physical Discomfort Within a Week Per Baseplate Change at Steady State |
1.9; 1.8 | 0.725 |
| SECONDARY Max Overall Ability to Move Around Within a Week Per Baseplate Change at Steady State |
1.3; 1.3 | 0.721 |
| SECONDARY Max Overall Ability to Stick the Stoma Bag Adhesive to the Skin Within a Week Per Baseplate Change at Steady State |
0.8; 0.9 | 0.753 |
| SECONDARY Discoloration Area (cm^2) Per Baseplate Change at Steady State |
18.5; 17.2 | 0.331 |
| SECONDARY Intensity of Discolorated Area Scored Per Baseplate Change at Steady State After Three Weeks of Product Use |
107.1; 95.4 | 0.239 |
| SECONDARY Total Discoloration, Erosion, and Tissue Overgrowth (DET) Score by End of Treatment at Steady State |
3.5; 3.8 | 0.322 |
| SECONDARY Discoloration Item Score by End of Treatment at Steady State |
2.4; 2.6 | 0.343 |
| SECONDARY Erosion Item Score by End of Treatment at Steady State |
0.7; 0.9 | 0.387 |
| SECONDARY Tissue Overgrowth Item Score by End of Treatment at Steady State |
0.3; 0.3 | 0.899 |
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 subjects. The study is a randomized, open-label, comparative study.
Eligibility Criteria
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
-
Data sourced from ClinicalTrials.gov (NCT04101318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.