Evaluation of the Effect of Output on New Adhesives

N/ACompletedNCT03257774

Coloplast A/S6 enrolled

Overview

The study investigates the impanct real output has on the adhesion of a new adhesive

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

Adhesive strip AOTHER

Strip consisting of a newly developed adhesive

Adhesive strip BOTHER

Strip consisting of a newly developed adhesive

Adhesive strip COTHER

Strip consisting 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 a stoma for more than one year 4. Have intact skin on the area used in the evalua-tion 5. Has a stoma with a diameter up to (≤) 35 mm 6. Have a peristomal area accessible for application of 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 peristo-mal- or abdominal area (assessed by investigating scientist) 5. Actively 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

The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin.

Time frame: 8 hours

Data from ClinicalTrials.gov

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