Preliminary Evaluation of CASTLE Barrier North American Prototype
- Conditions
- Peristomal Skin Complication
- Registration Number
- NCT01413672
- Lead Sponsor
- Hollister Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peristomal skin irritation 30 days
- Secondary Outcome Measures
Name Time Method Security 30 days wear time, lifting of barrier from skin, leakage
Trial Locations
- Locations (5)
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
Burke Pharmaceutical Research🇺🇸Hot Springs, Arkansas, United States