Evaluation of the Influence of Output on Skin Wearing a New Adhesive

The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.

Completed

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Key information

Conditions

Ileostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have had a stoma for more than one year
Have intact skin on the area used in the evalua-tion
Has a stoma with a diameter up to (≤) 35 mm
Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

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)
Actively participating in other interventional clinical investigations or have previously participated in this investigation.

Treatment and study plan

New adhesive strip

Other

This is a newly developed strip.

Primary outcomes

Trans epidermal water loss

Time frame: 24 hours

The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran 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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Evaluation of the Influence of Output in Skin Covered by Newly Developed Adhesives

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jun 27, 2017
Registry last updated: Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed