Evaluation of the Influence of Output on Skin Covered by Adhesives

N/ACompletedNCT03000881

Coloplast A/S15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

standard adhesiveOTHER

This is a standard adhesive (hydrocolloid)

New adhesive stripOTHER

This is a newly developed adhesive strip

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 -

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Trans Epidermal Water Loss

Time frame: 8 hours

Data from ClinicalTrials.gov

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