Peristomal Skin Complication
Conditions
Keywords
ostomy, colostomy, ileostomy, barrier, irritation
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.
Interventions
DEVICEUse of CASTLE barrier
Test barrier to be used in place of normal barrier. Otherwise normal routine is followed
Sponsors
Hollister Incorporated
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peristomal skin irritation | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Security | 30 days | wear time, lifting of barrier from skin, leakage |
Countries
Canada, United States
Outcome results
None listed