Ileostomy-stoma Clinical Trial
| Verified date | August 2016 |
| Source | Coloplast A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Ethics Committee |
| Study type | Interventional |
This study investigates the impact of real output on the adhesion of two adhesives.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Coloplast A/S | Humlebaek |
| Lead Sponsor | Collaborator |
|---|---|
| Coloplast A/S |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Peel force | The peel force was measured when the adhesive was removed | 12 hours | No |