Trial record 8 of 26 for:    colostomy | Open Studies

The Influence of Baseplate Adhesive on the Degree of Leakage

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Coloplast A/S
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01995357
First received: November 21, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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


Condition Intervention
Colostomy Stoma
Ileostomy Stoma
Device: Coloplast Test A
Device: Coloplast Test B
Device: Standard product

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Degree of leakage [ Time Frame: 10 (- 2 days) ] [ Designated as safety issue: No ]
    Degree of leakage measured with a 32 point scale


Estimated Enrollment: 26
Study Start Date: October 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995357

Contacts
Contact: Lea JT Rasmussen +45 4911 4943 dklejtr@coloplast.dk

Locations
Denmark
Coloplast A/S Recruiting
Humlebæk, Denmark, 3050
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Birte P Jakobsen, MD Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01995357     History of Changes
Other Study ID Numbers: CP244
Study First Received: November 21, 2013
Last Updated: November 21, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

ClinicalTrials.gov processed this record on August 01, 2014