Ostomy - Ileostomy or Colostomy
Conditions
Brief summary
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
Interventions
DEVICETest A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
DEVICETest B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
DEVICEComparator
Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To participate in the study, it is mandatory that the subject fulfill all inclusions criteria: * Have given written informed consent and signed 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 * Have a stoma with a diameter between 15 and 43 mm * Be able to handle the product themselves * Be able to use a custom cut product * Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks * Currently using a 1-piece flat product or a 1-piece soft convex product * Be willing to test products with open bag size maxi * Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B * Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product * Be suitable for participating in the investigation * Be willing to take/have taken pictures of the stoma before, during and after application of product
Exclusion criteria
Subjects complying with the following criteria must be excluded from participation in the clinical investigation: * Are currently receiving or have within the past 2 months received radio-and/or chemotherapy * Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment * 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 peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse) * Have a loop stoma * Have known hypersensitivity towards any of the test products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fit to body | 14 +/- 2 days | Subjects will evaluate the fit to body for each product by answering the question How was the base plates ability to fit the body contours in the area around the stoma? The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score. |
Countries
Netherlands, United Kingdom
Outcome results
None listed