Evaluation of the Effect of Output on Newly Developed Adhesives
Not Applicable
Completed
- Conditions
- Ileostomy - Stoma
- Registration Number
- NCT03200418
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The study investigates the impact real output has on the adhesion of the adhesives.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than one year
- Have intact skin on the area used in the evaluation
- Has a stoma with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
Exclusion Criteria
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment.
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- Actively participating in other interventional clinical investigations or have previously participated in this investigation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Trans epidermal water loss 8 hours The trans epidermal water loss is measured on the peristomal skin using a probe. 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 natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Coloplast A/S
🇩🇰Humlebaek, Denmark
Coloplast A/S🇩🇰Humlebaek, Denmark