Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: LT-25; Other: Standard adhesive 1; Other: 33-20; Other: Standard adhesive 2; Other: LT-21; Other: LT-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03289013

CP267_02

Details and patient eligibility

About

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

Enrollment: 5 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: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Testing of new adhesive strips

Experimental group

Description:

Each subject will test six adhesive strips on pre-stripped skin. 1. Standard adhesive 1 2. Standard adhesive 2 3. LT-2 4. LT-21 5. LT-25 6. 33-20 The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.

Treatment:

Other: LT-21

Other: LT-2

Other: LT-25

Other: 33-20

Other: Standard adhesive 1

Other: Standard adhesive 2