Evaluation of the Effect of Output on Newly Developed Adhesives

N/ACompletedNCT03200418

Coloplast A/S6 enrolled

Overview

The study investigates the impact real output has on the adhesion of the adhesives.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

Standard hydrocolloid adhesiveOTHER

This patch is made of standard hydrocolloid adhesive

P-4OTHER

This patch is made of new adhesive

P-15OTHER

This patch is made of new adhesive

P-16

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 evaluation 5. Has a stoma 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 (tab-let/injection) treatment. 3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal- 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. The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin.

Time frame: 8 hours

Data from ClinicalTrials.gov

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