Ileostomy - Stoma
Conditions
Brief summary
The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
Interventions
DEVICESenSura Mio
SenSura Mio is a marked ostomy device which is used as the comparator in this study
DEVICEColoplast Ostomy device 1
Coloplast Ostomy device 1 a newly developed ostomy device
DEVICEColoplast Ostomy device
Coloplast Ostomy device 2 a newly developed ostomy device
DEVICEColoplast Ostomy device 3
Coloplast Ostomy device 3 a newly developed ostomy device
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
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. Must be able to use custom cut product 5. Can use a product with max cut size 45 mm 6. Self-reported problems with leakage (3 x within 14 days) 7. 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 are 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 4.1. Exception: Participation in other Coloplast in-house clinical investigations are 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 |
|---|---|---|
| Trans epidermal water loss | 14 days | Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage |
Countries
Denmark, Netherlands
Outcome results
None listed