Ileostomy - Stoma
Conditions
Brief summary
The study investigates the impanct real output has on the adhesion of a new adhesive
Interventions
OTHERAdhesive strip A
Strip consisting of a newly developed adhesive
OTHERAdhesive strip B
Strip consisting of a newly developed adhesive
OTHERAdhesive strip C
Strip consisting of a newly developed adhesive
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 a stoma for more than one year 4. Have intact skin on the area used in the evalua-tion 5. Has a stoma with a diameter up to (≤) 35 mm 6. Have a peristomal area accessible for application of 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 peristo-mal- or abdominal area (assessed by investigating scientist) 5. Actively participating in other interventional clinical investigations or have previously participated in this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans epidermal water loss | 8 hours | The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin. |
Countries
Denmark
Outcome results
None listed