Ileostomy - Stoma
Conditions
Brief summary
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive
Interventions
OTHERNew adhesive strip
This is a strip made of a newly developed adhesive. This adhesive might in the future be part of an ostomy product.
this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.
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 is measure by trans epidermal water loss after removing the adhesive strip. |
Countries
Denmark
Outcome results
None listed