Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Influence of Baseplate Adhesive on the Degree of Leakage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995357
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : February 3, 2015
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.

Condition or disease Intervention/treatment Phase
Colostomy Stoma Ileostomy Stoma Device: Coloplast Test A Device: Coloplast Test B Device: Standard product Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995357


Locations
Layout table for location information
Denmark
Coloplast A/S
Humlebæk, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Investigators
Layout table for investigator information
Principal Investigator: Birte P Jakobsen, MD Coloplast A/S
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01995357    
Other Study ID Numbers: CP244
First Posted: November 26, 2013    Key Record Dates
Results First Posted: February 3, 2015
Last Update Posted: February 3, 2015
Last Verified: February 2015