Preliminary Evaluation of CASTLE Barrier North American Prototype

Hollister

Status: Completed

Conditions: Peristomal Skin Complication

Treatments: Device: Use of CASTLE barrier

Study type: Observational

Funder types: Industry

Identifiers

NCT01413672

5075-O

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

person with ostomy

Description:

Community dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery.

Treatment:

Device: Use of CASTLE barrier