The Influence of Output on Skin Covered by Adhesive With Topfilm

Coloplast A/S15 enrolled

Overview

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

New adhesive stripOTHER

This is a newly developed adhesive strip that in the future might be part of an ostomy device

Standard adhesive stripOTHER

This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 -

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Trans epidermal water loss

the condition of the skin (trans epidermal water loss) is measured after removing the adhesive from the skin

Time frame: 6 hours

Data from ClinicalTrials.gov

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