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Preliminary Evaluation of CASTLE Barrier North American Prototype

This study has been completed.
Information provided by (Responsible Party):
Hollister Incorporated Identifier:
First received: August 6, 2011
Last updated: December 9, 2011
Last verified: December 2011
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.

Condition Intervention
Peristomal Skin Complication Device: Use of CASTLE barrier

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype

Resource links provided by NLM:

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Peristomal skin irritation [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Security [ Time Frame: 30 days ]
    wear time, lifting of barrier from skin, leakage

Enrollment: 30
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
person with ostomy
Community dwelling subject with either colostomy or ileostomy and at least 3 months post-surgery.
Device: Use of CASTLE barrier
Test barrier to be used in place of normal barrier. Otherwise normal routine is followed


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects currently known to investigators

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01413672

United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, Florida
ET Nursing Services
Jacksonville, Florida, United States, 32246
United States, Missouri
St. Louis Medical
Fenton, Missouri, United States, 63026
Restored Images
Kansas City, Missouri, United States, 64119
Canada, British Columbia
Ostomy Care & Supply Centre
New Westminster, British Columbia, Canada, V3M 2T5
Sponsors and Collaborators
Hollister Incorporated
Study Director: Richard Murahata, Ph.D. Hollister Incorporated
  More Information

Responsible Party: Hollister Incorporated Identifier: NCT01413672     History of Changes
Other Study ID Numbers: 5075-O
Study First Received: August 6, 2011
Last Updated: December 9, 2011

Keywords provided by Hollister Incorporated:
irritation processed this record on August 23, 2017