Evaluation of the Performance of an Adhesive Strip

N/ACompletedNCT03419013

Coloplast A/S7 enrolled

Overview

This study investigated the performance of a new adhesive strip when impacted by output

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

New adhesive stripOTHER

This strip is made of a newly developed adhesive

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 test product (assessed by investigator) 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 investigator) 5. Participating in other interventional clinical investigations or have previously participated in this investigation

Locations (1)

Coloplast A/S

Humlebæk, Denmark

Outcomes

Primary Outcomes

Trans epidermal water loss

trans epidermal water loss is a measure of the skins barrier function. There is always a oss of water from the skin due to evaporation. However, when the skin barrier is damaged this evaporation increases. Thus, trans epidermal water loss can be used to assess the skins barrier function

Time frame: 24 hours

Data from ClinicalTrials.gov

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