Evaluation of the Performance of a New… | Clinical Trial

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 evaluation
Has a stoma with a diameter up to (≤) 35 mm
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.

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.

Treatment and study plan

New adhesive strip

Other

This is a strip made of a newly developed adhesive

Primary outcomes

Trans epidermal water loss

Time frame: 8 hours

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

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 22, 2017
Registry last updated: Nov 8, 2017

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