Preliminary Evaluation of CASTLE Barrier North American Prototype

The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.

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Key information

Conditions

Peristomal Skin Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ostomy Care & Supply Centre, New Westminster, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

at least 18 years of age has colostomy or ileostomy current user of two-piece, flat, tape bordered barrier mild to moderate skin peristomal skin irritation community dwelling and cares for stoma independently at least 3 months post-operative provides informed consent

Exclusion criteria

presence of fistula on or near stoma prior participation in stoma care study within past 30 days pregnant or lactating (interview only) uses convex product, paste and/or rings known allergy to test barrier composition existing medical condition or therapy that might affect ability to participate or interpretation of study results

Treatment and study plan

Use of CASTLE barrier

Device

Test barrier to be used in place of normal barrier. Otherwise normal routine is followed

Primary outcomes

Peristomal skin irritation

Time frame: 30 days

Secondary outcomes

Security

Time frame: 30 days

wear time, lifting of barrier from skin, leakage

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Official study title

Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Aug 10, 2011
Registry last updated: Dec 12, 2011

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