Preliminary Evaluation of CASTLE Barrier North American Prototype

December 9, 2011 updated by: Hollister Incorporated

Peristomal Skin Irritation: A Preliminary Evaluation of CASTLE Barrier North American Prototype

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3M 2T5
        • Ostomy Care & Supply Centre
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
    • Florida
      • Jacksonville, Florida, United States, 32246
        • ET Nursing Services
    • Missouri
      • Fenton, Missouri, United States, 63026
        • St. Louis Medical
      • Kansas City, Missouri, United States, 64119
        • Restored Images

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

subjects currently known to investigators

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peristomal skin irritation
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security
Time Frame: 30 days
wear time, lifting of barrier from skin, leakage
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hollister Incorporated

Investigators

  • Study Director: Richard Murahata, Ph.D., Hollister Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 6, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (ESTIMATE)

August 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2011

Last Update Submitted That Met QC Criteria

December 9, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5075-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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