Preliminary Evaluation of CASTLE Barrier North American Prototype

Peristomal Skin Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413672
• Other study ID #: 5075-O
• Status: Completed
• Phase: N/A
• First received: August 6, 2011
• Last updated: December 9, 2011
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Peristomal Skin Complication

Intervention

Device:
• Use of CASTLE barrier
Test barrier to be used in place of normal barrier. Otherwise normal routine is followed

Locations

Country	Name	City	State
Canada	Ostomy Care & Supply Centre	New Westminster	British Columbia
United States	St. Louis Medical	Fenton	Missouri
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	ET Nursing Services	Jacksonville	Florida
United States	Restored Images	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peristomal skin irritation		30 days	Yes
Secondary	Security	wear time, lifting of barrier from skin, leakage	30 days	No