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

An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy

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

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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: Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active); 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; Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.; Device: Coloplast Test product 2; Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S; 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
EXPERIMENTAL: 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: Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active); 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; Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.; Device: Coloplast Test product 2; Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S; 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
EXPERIMENTAL: 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: Coloplast Test product 1 and thereafter Coloplast Test product 2; Coloplast Test product 2 and thereafter Coloplast Test product 1	Device: Coloplast Test product 1; Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.; Device: Coloplast Test product 2; Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte Petersen, Coloplast A/S

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: October 1, 2013
• First Posted (ESTIMATE): October 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CP221