Ileostomy - Stoma
Conditions
Brief summary
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.
Interventions
OTHERNew adhesive strip
This is a newly developed adhesive strip that in the future might be part of an ostomy device
This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have had an ileostomy for more than one year 4. Have intact skin on the area used in the evaluation 5. Has an ileostomy with a diameter up to (≤) 35 mm 6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
Exclusion criteria
1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) 5. Participating in other interventional clinical investigations or have previously participated in this evaluation -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans epidermal water loss | 6 hours | the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin |
Countries
Denmark
Outcome results
None listed