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Preliminary Evaluation of CASTLE Barrier North American Prototype

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01413672
First received: August 6, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Ostomy
U.S. FDA Resources

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Peristomal skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Security [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

subjects currently known to investigators

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413672

Locations
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
Investigators
Study Director: Richard Murahata, Ph.D. Hollister Incorporated
  More Information

No publications provided

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01413672     History of Changes
Other Study ID Numbers: 5075-O
Study First Received: August 6, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Hollister Incorporated:
ostomy
colostomy
ileostomy
barrier
irritation

ClinicalTrials.gov processed this record on May 22, 2013