Assessment of a Skin Barrier

September 22, 2015 updated by: Hollister Incorporated

User Assessment of a One-Piece Skin Barrier

This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.

Study Overview

Status

Terminated

Conditions

Detailed Description

Design:

This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.

Study Type

Observational

Enrollment (Actual)

18

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
      • Harrow, United Kingdom, HA1 3UJ
        • St. Mark's Hospital
      • London, United Kingdom, SW17 0QT
        • St. George's 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

Sampling Method

Non-Probability Sample

Study Population

Current users of either Dansac flat Nova or NovaLife skin barriers with drainable pouches who have an ileostomy.

Description

Inclusion Criteria:

  1. is at least 18 years of age.
  2. has an ileostomy.
  3. is at least six weeks postoperative.
  4. lives and cares for their stoma independently in the community.
  5. currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier.
  6. currently uses a drainable pouch.
  7. is able to wear a 1-piece flat cut-to-fit 10-55 mm.
  8. Has a peristomal skin irritation score of 2 or less.
  9. is willing to follow the protocol as demonstrated by signing the informed consent and who in the opinion of the investigator is qualified to participate.

Exclusion Criteria:

  1. has a fistula on or near the stoma.
  2. has been involved in a study involving stoma care with in the last 30 days.
  3. is pregnant or lactating, as determined by interview only.
  4. is undergoing chemotherapy, radiation or steroid therapy.
  5. has an existing medical condition that would compromise their participation in the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
barrier adhesion
Time Frame: 10 days
Questionnaire will be provided to subject to assess barrier adhesion.
10 days
barrier tack
Time Frame: 10 days
Questionnaire will be provided to subject to assess barrier tack.
10 days
comfort
Time Frame: 10 days
Questionnaire will be provided to subject to assess comfort.
10 days
leakage
Time Frame: 10 days
Questionnaire will be provided to subject to assess leakage.
10 days
ease of barrier removal
Time Frame: 10 days
Questionnaire will be provided to subject to assess ease of barrier removal.
10 days

Collaborators and Investigators

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

Sponsor

Hollister Incorporated

Collaborators

London North West Healthcare NHS Trust
St George's Healthcare NHS Trust

Investigators

  • Principal Investigator: Heather Dennis, St. George's Hospital
  • Principal Investigator: Sarah Varma, Stoma Nurse, St. Mark's Hospital

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, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5566-O

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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