Evaluation of the Influence of Output on a Newly Develop Adhesive

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: Standard adhesive strip; Other: New adhesive strip

Study type: Interventional

Funder types: Industry

Identifiers

NCT02886403

CP265_02

Details and patient eligibility

About

The study investigates the impact real output has on the adhesion of adhesives.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion criteria

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Cohort 02

Experimental group

Description:

This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output. There are two visits: The first visit: Two adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not. The second visit: Two adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.

Treatment:

Other: New adhesive strip

Other: Standard adhesive strip