The Advocate Study

June 13, 2018 updated by: Hollister Incorporated

A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.

Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

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
      • Kelowna, British Columbia, Canada, V1M 3C2
        • Lakeside Medicine Center
      • Nanaimo, British Columbia, Canada, V9S 5W4
        • Pharmasave
      • New Westminster, British Columbia, Canada, V3M 2T5
        • Ostomy Care Centre
    • Ontario
      • Toronto, Ontario, Canada, M1E 489
        • Rouge Valley Health System
  • United States
    • California
      • Riverside, California, United States, 92508
        • Stoia Consultants
    • Florida
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Winter Haven, Florida, United States, 33881
        • Winter Haven Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Indiana Health Ball Memorial University
    • Missouri
      • Kansas City, Missouri, United States, 64119
        • Restored Images
    • Ohio
      • Cuyahoga Falls, Ohio, United States, 44223
        • Klein's Orthopedic & Medical Supply
      • Youngstown, Ohio, United States, 44504
        • St. Elizabeth Hospital

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

Description

Inclusion Criteria:

Ostomy patients who:

  • Have healthy peristomal skin
  • Are within 12 weeks post op

Exclusion Criteria:

Ostomy patients who:

  • Have a fistula, wound, lesion or suspected infection in the peristomal area
  • Are in-patient in healthcare facility

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Test Ostomy Barrier
The test product is a new Hollister ostomy barrier.
Device: Test Ostomy Barrier
Other: Control Ostomy Barrier
The control product is a currently marketed Hollister ostomy barrier.
Device: Control Ostomy Barrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stoma Related Cost of Care
Time Frame: 12 weeks
12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peristomal Skin Complication Rate
Time Frame: 8 weeks
Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.
8 weeks

Collaborators and Investigators

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

Sponsor

Hollister Incorporated

Investigators

  • Study Director: Mark Kalifa, 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 (Actual)

March 16, 2015

Primary Completion (Actual)

January 20, 2017

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 5787-O

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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