NCT03439176

Investigating the Adhesion of New Adhesive to the Skin

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ileostomy - Stoma

Interventions

Type	Name	Description
OTHER	Standard adhesive 1	This strip contains a standard hydrocolloid adhesive found in ostomy devices
OTHER	Standard adhesive 2	This strip contains a standard hydrocolloid adhesive found in ostomy devices
OTHER	PL4	This strip contains a new adhesive
OTHER	PL16-L	This strip contains a new adhesive

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-02-15
• Completion: 2020-06-30
• First posted: 2018-02-20
• Last updated: 2020-01-27

Locations

1 site across 1 country: Denmark