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Preliminary Evaluation of CASTLE Barrier North American Prototype

NCT ID: NCT01413672

Last Updated: 2011-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peristomal Skin Complication

Keywords

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ostomy colostomy ileostomy barrier irritation

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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person with ostomy

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

Use of CASTLE barrier

Intervention Type DEVICE

Test barrier to be used in place of normal barrier. Otherwise normal routine is followed

Interventions

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Use of CASTLE barrier

Test barrier to be used in place of normal barrier. Otherwise normal routine is followed

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hollister Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Murahata, Ph.D.

Role: STUDY_DIRECTOR

Hollister Incorporated

Locations

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Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

ET Nursing Services

Jacksonville, Florida, United States

Site Status

St. Louis Medical

Fenton, Missouri, United States

Site Status

Restored Images

Kansas City, Missouri, United States

Site Status

Ostomy Care & Supply Centre

New Westminster, British Columbia, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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5075-O

Identifier Type: -

Identifier Source: org_study_id