Evaluation of the Influence of Output on Skin Covered by Adhesives

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Other: standard adhesive; Other: New adhesive strip

Study type: Interventional

Funder types: Industry

Identifiers

NCT03000881

CP265_06

Details and patient eligibility

About

The study investigates the impact real output has on peristomal skin covered by two different adhesives

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have had an ileostomy for more than one year
• Have intact skin on the area used in the evaluation
• Has an ileostomy with a diameter up to 35 mm
• Have a peristomal area accessible for application of adhesive strips

Exclusion criteria

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
• 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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15 participants in 1 patient group

Cohort 6

Experimental group

Description:

This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.

Treatment:

Other: standard adhesive

Other: New adhesive strip