Ileostomy
Conditions
Brief summary
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.
Interventions
OTHERBuffer
The sleeve contains phosphate buffered saline buffer
OTHEROwn output
The sleeve contains the subject own ileal effluent
OTHERsimulated output
The sleeve contains simulated output
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 |
|---|---|---|
| Remaining adhesive area of adhesive | 30 hours | The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area. |
Countries
Denmark
Outcome results
None listed