Preliminary Evaluation of CASTLE Barrier North American Prototype (NCT01413672) | Clinical Trial Compass
CompletedNot Applicable
Preliminary Evaluation of CASTLE Barrier North American Prototype
United States, Canada30 participantsStarted 2011-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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