Investigating the Adhesion of New Adhesive to the Skin

Coloplast

Status: Unknown

Conditions: Ileostomy - Stoma

Treatments: Other: Standard adhesive 2; Other: PL4; Other: PL16-L; Other: Standard adhesive 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03439176

CP267_3_5

Details and patient eligibility

About

The adhesion of the new adhesive strips is investigated on healthy volunteers

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion criteria

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Test of new adhesive strips

Experimental group

Description:

The subjects will test adhesives strips made of 4 different adhesives: Standard adhesive 1 Standard adhesive 2 PL4 PL16-L

Treatment:

Other: PL4

Other: Standard adhesive 2

Other: PL16-L

Other: Standard adhesive 1