NCT01413672

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

August 6, 2011

Last Update Submit

December 9, 2011

Conditions

Peristomal Skin Complication

Keywords

ostomycolostomyileostomybarrierirritation

Outcome Measures

Primary Outcomes (1)

  • Peristomal skin irritation

    30 days

Secondary Outcomes (1)

  • Security

    30 days

Study Arms (1)

person with ostomy

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

Device: Use of CASTLE barrier

Interventions

Use of CASTLE barrierDEVICE

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

person with ostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects currently known to investigators

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

ET Nursing Services

Jacksonville, Florida, 32246, United States

Location

St. Louis Medical

Fenton, Missouri, 63026, United States

Location

Restored Images

Kansas City, Missouri, 64119, United States

Location

Ostomy Care & Supply Centre

New Westminster, British Columbia, V3M 2T5, Canada

Location

Study Officials

  • Richard Murahata, Ph.D.

    Hollister Incorporated

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2011

First Posted

August 10, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations

CA(1)US(4)