The Influence of Adhesive Wafer Design on Fit to the Body

March 20, 2015 updated by: Coloplast A/S
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Netherlands
      • Groningen, Netherlands, 9713
        • QPS Netherlands
  • United Kingdom
      • Berkshire, United Kingdom, RG2 0TG
        • Synexus Thames Valley
      • Birmingham, United Kingdom, B15 2SQ
        • Synexus Midlands
      • Cardiff, United Kingdom, CF14 5GJ
        • Synexus Wales
      • Glasgow, United Kingdom, G20 0SP
        • Synexus Scotland
      • Gloucestershire, United Kingdom, G1537AN
        • Cheltenham General Hospital
      • Lancashire, United Kingdom, PR7 7NA
        • Synesxus Lancashire
      • Liverpool, United Kingdom, L22 0LG
        • Synexus Merseyside
      • Manchester, United Kingdom, M15 6SX
        • Synexus Manchester
      • Northumberland, United Kingdom, NE46 1QJ
        • Synexus North East

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:

To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:

  • Have given written informed consent and signed letter of Authority
  • Be at least 18 years of age and have full legal capacity
  • Have had their ileostomy or colostomy for at least 3 months
  • Have a stoma with a diameter between 15 and 43 mm
  • Be able to handle the product themselves
  • Be able to use a custom cut product
  • Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
  • Currently using a 1-piece flat product or a 1-piece soft convex product
  • Be willing to test products with open bag size maxi
  • Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
  • Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
  • Be suitable for participating in the investigation
  • Be willing to take/have taken pictures of the stoma before, during and after application of product

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

  • Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
  • Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
  • Are pregnant or breastfeeding
  • Are participating in other interventional clinical investigations or have previously participated in this investigation
  • Use irrigation during the investigation (flush the intestines with water)
  • Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
  • Have a loop stoma
  • Have known hypersensitivity towards any of the test products

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test A, Test B, Comparator
The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator.
Device: Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Experimental: Test A, Comparator, Test B
The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B.
Device: Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Experimental: Test B, Test A, Comparator
The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator.
Device: Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Experimental: Test B, Comparator, Test A
The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B.
Device: Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Experimental: Comparator, Test A, Test B
The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B
Device: Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.
Experimental: Comparator, Test B, Test A
The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A.
Device: Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
Device: Comparator

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fit to body
Time Frame: 14 +/- 2 days

Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?"

The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.
14 +/- 2 days

Collaborators and Investigators

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

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Khalid Abd-Elaziz, MD, QPS Netherlands
  • Principal Investigator: Susanne Eyre, MD, Synexus North East, United Kingdom
  • Principal Investigator: Gillian Hopkins, Cheltenham General Hospital, United Kingdom

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

July 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CP247

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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