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

NCT ID: NCT01957384

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment 1; First Coloplast Test product 1

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

Group Type: EXPERIMENTAL

Coloplast Test product 1

Intervention Type: DEVICE

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

Coloplast Test product 2

Intervention Type: DEVICE

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

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

Intervention Type: 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 2; First Coloplast Test product 2.

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

Group Type: EXPERIMENTAL

Coloplast Test product 1

Intervention Type: DEVICE

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

Coloplast Test product 2

Intervention Type: DEVICE

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

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

Intervention Type: 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 3,First Standard care (see below)

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

Group Type: EXPERIMENTAL

Coloplast Test product 1

Intervention Type: DEVICE

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

Coloplast Test product 2

Intervention Type: DEVICE

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

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

Intervention Type: 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

Interventions

Coloplast Test product 1

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

Intervention Type: DEVICE

Coloplast Test product 2

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birte Petersen

Role: PRINCIPAL_INVESTIGATOR

Coloplast A/S

Locations

Coloplast A/S

Humlebæk, , Denmark

Countries

Denmark

Other Identifiers

CP221

Identifier Type: -

Identifier Source: org_study_id