Evaluation of the Peel Force of New Adhesives From the Skin

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Other: Standard adhesive 1; Other: P-16; Other: Standard adhesive 2; Other: Standard adhesive 3; Other: P-4; Other: P-15

Study type: Interventional

Funder types: Industry

Identifiers

NCT03200444

CP267_01

Details and patient eligibility

About

This study investigates the impact and adhesion of new adhesives to the skin.

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

Testing of 6 adhesive strips

Experimental group

Description:

Each subject tests six adhesive strips on pre-striped skin. 1. Standard adhesive 1 2. standard adhesive 2 3. Standard adhesive 3 4. P-4 5. P-15 6. P-16 The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits.

Treatment:

Other: P-15

Other: P-4

Other: Standard adhesive 3

Other: Standard adhesive 2

Other: P-16

Other: Standard adhesive 1