A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Coloplast A/S
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Swelling of the adhesive
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Test of new adhesive strips
The subjects will test adhesives strips made of 4 different adhesives:
Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Intervention: Standard adhesive 1 (Other)
Test of new adhesive strips
The subjects will test adhesives strips made of 4 different adhesives:
Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Intervention: Standard adhesive 2 (Other)
Test of new adhesive strips
The subjects will test adhesives strips made of 4 different adhesives:
Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Intervention: PL4 (Other)
Test of new adhesive strips
The subjects will test adhesives strips made of 4 different adhesives:
Standard adhesive 1 Standard adhesive 2 PL4 PL16-L
Intervention: PL16-L (Other)
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)
Secondary Outcomes
No secondary outcomes reported