Preliminary Evaluation of CASTLE Barrier Prototype UK

February 22, 2016 updated by: Hollister Incorporated

Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas

The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a single-site, unblinded, historically controlled, first use in humans study of a stoma barrier with a new formulation. Approximately 34 subjects who are currently using a 2-piece tape bordered product and able and willing to wear a product will be enrolled. Each participant is provided with one box containing 20 of the test barriers to be used consecutively according to their normal routine. Each participant is also provided with a box containing 30 pouches selected to most closely resemble their current product. Participants are asked to record the time of application and time of removal of each test barrier and their assessment of relevant characteristics for each test barrier. A clinical evaluation of the peristomal skin is conducted at study entry, at approximately mid way through the study and again at its conclusion. Photographs are taken of the peristomal skin at each visit using a digital camera. Individual participation in terms of wearing the barrier is for 30 days or until the test barrier has been used up, whichever comes first. The study is comprised of 3 visits, an enrolment visit, a mid-study visit and a completion visit and a phone call at approximately day 7.

Study Type

Interventional

Enrollment (Actual)

3

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

  • United Kingdom
      • York, United Kingdom, YO31 8HE
        • York Teaching 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:

  • at least 18 years of age
  • has colostomy or ileostomy
  • current uses two piece tape bordered barrier
  • has mild to moderate peristomal skin irritation
  • cares for their stoma independently in the community
  • at least 3 months post-operative
  • provides informed consent

Exclusion Criteria:

  • has fistula on or near stoma
  • has been involved in stoma care study in the last 30 days
  • is pregnant or lactating (determined by interview only)
  • has existing medical condition that would compromise their participation or follow-up
  • currently uses convex ostomy products, paste and/or rings
  • is allergic to test barrier components
  • is undergoing chemo- or radiotherapy that may affect the interpretation of the 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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
CASTLE Barrier
Device: CASTLE barrier
Prototype barrier to be used in place of current two piece device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peristomal Skin Condition
Time Frame: 1 - 30 days
mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)
1 - 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security
Time Frame: 30 days
wear time leakage barrier erosion
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, PhD, 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

January 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4518-O
  • CIV-GB-11-07-001241 (Registry Identifier: Eudamed)

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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