The Influence of Baseplate Adhesive on the Degree of Leakage

February 2, 2015 updated by: Coloplast A/S

The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy

The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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

  • Denmark
      • Humlebæk, Denmark, 3050
        • Coloplast A/S

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:

  1. Have given written informed consent and signed letter of authority
  2. Be at least 18 years of age and have full legal capacity
  3. Have had their ileostomy/colostomy for at least 3 months
  4. Have a stoma with a diameter between 15 and 36 mm
  5. Be able to handle the products themselves
  6. Be able to use a custom cut product
  7. Normally experience faeces under the base plate at least 3 times during 2 weeks
  8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
  9. Be willing to test the test products without using paste and/or ring
  10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
  11. Be suitable for participation in the investigation
  12. Be able to present a negative result of a pregnancy test - for women of childbearing age

Exclusion Criteria:

  1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
  2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
  3. Are pregnant or breastfeeding
  4. Are participating in other interventional clinical investigations or have previously participated in this investigation
  5. Use irrigation during the investigation (flush the intestines with water)
  6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
  7. Have a loop stoma
  8. Have known hypersensitivity towards any of the test products (including adhesive remover)

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: First Coloplast Teast A; then Coloplast Test B

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.

The test sequence in this arm is:

Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
Device: Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Device: Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Device: Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Coloplast Test A; Then Standard product

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.

The test sequence in this arm is:

Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Device: Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Device: Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Device: Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Coloplast Test B; Then Colopast Test A

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.

The test sequence in this arm is:

Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
Device: Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Device: Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Device: Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Coloplast Test B; Then Standard product

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.

The test sequence in this arm is:

Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
Device: Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Device: Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Device: Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Standard product; Then Coloplast Test A

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.

The test sequence in this arm is:

Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
Device: Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Device: Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Device: Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
Experimental: First Standard Product, Then Coloplast test B

There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.

The test sequence in this arm is:

Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
Device: Coloplast Test A
Coloplast Test A is a newly developed ostomy appliance
Device: Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance.
Device: Standard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Leakage
Time Frame: 10 (- 2 days)

The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).

Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
10 (- 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: Birte P Jakobsen, MD, Coloplast A/S

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

October 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CP244

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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