The Influence of Baseplate Adhesive on the Degree of Leakage

NCT01995357 | Completed Results

• 1 other identifier: CP244
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colostomy Stoma; Ileostomy Stoma

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  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)

Study Arms (6)

First Coloplast Teast A; then Coloplast Test B

EXPERIMENTAL

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; Device: Coloplast Test B; Device: Standard product

First Coloplast Test A; Then Standard product

EXPERIMENTAL

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; Device: Coloplast Test B; Device: Standard product

First Coloplast Test B; Then Colopast Test A

EXPERIMENTAL

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; Device: Coloplast Test B; Device: Standard product

First Coloplast Test B; Then Standard product

EXPERIMENTAL

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; Device: Coloplast Test B; Device: Standard product

First Standard product; Then Coloplast Test A

EXPERIMENTAL

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; Device: Coloplast Test B; Device: Standard product

First Standard Product, Then Coloplast test B

EXPERIMENTAL

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; Device: Coloplast Test B; Device: Standard product

Interventions

Coloplast Test A DEVICE

Coloplast Test A is a newly developed ostomy appliance

First Coloplast Teast A; then Coloplast Test B; First Coloplast Test A; Then Standard product; First Coloplast Test B; Then Colopast Test A; First Coloplast Test B; Then Standard product; First Standard Product, Then Coloplast test B; First Standard product; Then Coloplast Test A

Coloplast Test B DEVICE

Coloplast Test B is a newly developed ostomy appliance.

First Coloplast Teast A; then Coloplast Test B; First Coloplast Test A; Then Standard product; First Coloplast Test B; Then Colopast Test A; First Coloplast Test B; Then Standard product; First Standard Product, Then Coloplast test B; First Standard product; Then Coloplast Test A

Standard product DEVICE

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.

First Coloplast Teast A; then Coloplast Test B; First Coloplast Test A; Then Standard product; First Coloplast Test B; Then Colopast Test A; First Coloplast Test B; Then Standard product; First Standard Product, Then Coloplast test B; First Standard product; Then Coloplast Test A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/colostomy for at least 3 months
• Have a stoma with a diameter between 15 and 36 mm
• Be able to handle the products themselves
• Be able to use a custom cut product
• Normally experience faeces under the base plate at least 3 times during 2 weeks
• 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
• Be willing to test the test products without using paste and/or ring
• Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
• Be suitable for participation in the investigation
• Be able to present a negative result of a pregnancy test - for women of childbearing age

You may not qualify if:

• 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 local or systemic steroid treatment in the peristomal area
• 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 peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
• Have a loop stoma
• Have known hypersensitivity towards any of the test products (including adhesive remover)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: MD, Medical Director
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 1395

Study Officials

• Birte P Jakobsen, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2015
• Results First Posted: February 3, 2015

Record last verified: 2015-02

Locations

DK (1)