Ileostomy - Stoma
Conditions
Brief summary
The purpose was to investigate the performance of a new ostomy device measured with a measuring device.
Interventions
DEVICEColoplast ostomy device
the test product is a newly developed Coloplast ostomy device
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent and in DK: signed a letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Have had their ileostomy for at least 3 months 4. Can use a product with max cut size 45 mm 5. Self-reported problems with leakage (3 x within 14 days) 6. Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period 7. Must be able to use custom cut product 8. Minimum change of product every third day 9. Get a negative result of a pregnancy test for women of childbearing age (only DK)
Exclusion criteria
1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) 2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. 3. Are pregnant or breastfeeding 4. Are participating in other interventional clinical investigations or have previously participated in this investigation Exception: Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wear time (hours) | 14 days | Wear time is recorded at each baseplate change |
Countries
Denmark
Outcome results
None listed