Preliminary Evaluation of CASTLE Barrier North American Prototype

Completed

Conditions studied: Peristomal Skin Complication

In brief

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.

Key facts

Study ID

NCT01413672

Run by

Hollister Incorporated

People needed

30

Starts

2011-08-01

Expected to finish

2011-12-01

Last updated by the study team

2011-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• ET Nursing Services — Jacksonville, Florida, United States
• St. Louis Medical — Fenton, Missouri, United States
• Restored Images — Kansas City, Missouri, United States
• Ostomy Care & Supply Centre — New Westminster, British Columbia, Canada

Full record on ClinicalTrials.gov

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