Preliminary Evaluation of CASTLE Barrier North American Prototype

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01413672
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : December 12, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Peristomal Skin Complication Device: Use of CASTLE barrier

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype
Study Start Date : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy
U.S. FDA Resources

Group/Cohort Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Hollister Incorporated Identifier: NCT01413672     History of Changes
Other Study ID Numbers: 5075-O
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by Hollister Incorporated: