A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ileostomy - Stoma
- Sponsor
- Coloplast A/S
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Swelling of the adhesive
- Last Updated
- 6 years ago
Overview
Brief Summary
The adhesion of the new adhesive strips is investigated on healthy volunteers
Detailed Description
Inclusion visit: * Introduction to the study * Inclusion in study * Baseline information is obtained * Instruct subject to pre-strip of abdominal skin Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin): * Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip) * Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Adhesive strips are weighted and applied * Potential shower/bicycle exercise (max 60 minutes) * Adhesive strips are removed at pre-defined timeslots (peel force measured) * Discomfort when strip was peeled of is evaluated by subject (VAS) * Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Acclimatization ½ * Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Adhesive strips are weighed * Photo of adhesive strips The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have intact skin on the area used in the investigation
Exclusion Criteria
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- •Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Have dermatological problems in the abdominal area (assessed by investigator)
Outcomes
Primary Outcomes
Swelling of the adhesive
Time Frame: 24 hours
Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)