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

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: 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)

• Registration Number: NCT01957384
• Lead Sponsor: Coloplast A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Results First Submitted: 2013-11-21
• Results First Submitted QC: 2014-01-21
• Status Verified: 2014-02
• Results First Posted: 2014-02-14
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1; First Coloplast Test product 1	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
Treatment 1; First Coloplast Test product 1	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 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
Treatment 1; First Coloplast Test product 1	Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)	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
Treatment 2; First Coloplast Test product 2.	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 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
Treatment 2; First Coloplast Test product 2.	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
Treatment 2; First Coloplast Test product 2.	Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)	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
Treatment 3,First Standard care (see below)	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 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
Treatment 3,First Standard care (see below)	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 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
Treatment 3,First Standard care (see below)	Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)	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

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	Up to 14 days per test product	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

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark