Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care

NCT01957384 | Completed Results

• 1 other identifier: CP221
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S

  Up to 14 days per test product

Study Arms (3)

Treatment 1; First Coloplast Test product 1

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 1 are randomised to secondly test either: 1. Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) 2. Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2

Device: Coloplast Test product 1; Device: Coloplast Test product 2; Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Treatment 2; First Coloplast Test product 2.

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 2 are randomised to secondly test either: 1. Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) 2. Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1

Device: Coloplast Test product 1; Device: Coloplast Test product 2; Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Treatment 3,First Standard care (see below)

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast Test product 2 2. Coloplast Test product 2 and thereafter Coloplast Test product 1

Device: Coloplast Test product 1; Device: Coloplast Test product 2; Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)

Interventions

Coloplast Test product 1 DEVICE

Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.

Treatment 1; First Coloplast Test product 1; Treatment 2; First Coloplast Test product 2.; Treatment 3,First Standard care (see below)

Coloplast Test product 2 DEVICE

Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S

Treatment 1; First Coloplast Test product 1; Treatment 2; First Coloplast Test product 2.; Treatment 3,First Standard care (see below)

Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) DEVICE

Standard Care was the subject usual ostomy appliance and had to be one of the following: * Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, * Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate * Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate * ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate * B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate

Treatment 1; First Coloplast Test product 1; Treatment 2; First Coloplast Test product 2.; Treatment 3,First Standard care (see below)

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
• Be at least 18 years of age and have full legal capacity
• Be able to handle the bags themselves or with help from caregiver
• Have an ileostomy with a diameter between 15 and 45 mm
• Have had their ostomy for at least three months
• Currently use a 1-piece flat standard care product with open bag
• Negative result of a pregnancy test for women of childbearing age
• Custom-cut product user
• Be suitable for participation in the investigation

You may not qualify if:

• Use irrigation during the study (flush the stoma with water)
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy
• Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Max three days wear time
• Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, Denmark

Location

Results Point of Contact

• Title: Marian Dyreborg Sinvani, Clinical Manager
• Organization: Coloplast A/S

dkmards@coloplast.com

+45 4911 2356

Study Officials

• Birte Petersen

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: October 8, 2013
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 27, 2014
• Results First Posted: February 14, 2014

Record last verified: 2014-02

Locations

DK (1)