Status:
COMPLETED
Preliminary Evaluation of CASTLE Barrier North American Prototype
Lead Sponsor:
Hollister Incorporated
Conditions:
Peristomal Skin Complication
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01413672
Start Date
August 1 2011
End Date
December 1 2011
Last Update
December 12 2011
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
ET Nursing Services
Jacksonville, Florida, United States, 32246
3
St. Louis Medical
Fenton, Missouri, United States, 63026
4
Restored Images
Kansas City, Missouri, United States, 64119