Ileostomy
Conditions
Brief summary
The objective is to investigate the impact that faecal output has on adhesives.
Interventions
OTHERPatch 1
Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
OTHERPatch 2
Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
OTHERPatch 3
Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip
OTHERPatch 4
Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
OTHERpatch 5
Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
OTHERPatch 6
Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 3 months 4. Have intact skin on the area used in the evaluation 5. Has an ileostomy with a diameter (≤) 35mm
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 area 5. Convex user 6. Participate in other interventional clinical investigations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remaining adherent area of the adhesive | 8 hours | The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling. |
Countries
Denmark
Outcome results
None listed