Ileostomy - Stoma Clinical Trial
Official title:
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put
Verified date | January 2019 |
Source | Coloplast A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates the performance of a new adhesive
Status | Completed |
Enrollment | 6 |
Est. completion date | February 20, 2018 |
Est. primary completion date | February 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
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 a stoma for more than one year 4. Have intact skin on the area used in the evaluation 5. Has a stoma 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. Actively participating in other interventional clinical investigations or have previously participated in this investigation. 5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265) |
Country | Name | City | State |
---|---|---|---|
Denmark | Coloplast A/S | Humlebæk |
Lead Sponsor | Collaborator |
---|---|
Coloplast A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | trans epidermal water loss | The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage | 24 hours |
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