Investigation of a New 1-piece Convex Ostomy Product

Not Applicable

Completed

• Conditions: Stoma Ileostomy; Stoma Colostomy
• Interventions: Device: Coloplast Test; Device: Own product; Device: Competitor soft convex

• Registration Number: NCT02043782
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-11-04
• Results First Submitted QC: 2015-11-04
• Results First Posted: 2015-12-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Are at least 18 years of age and have full legal capacity.
• Have had an ileostomy/colostomy for more than 3 months
• Have used a 1-piece flat ostomy product for the last 1 month
• Has given written Informed Consent and signed the letter of authority
• Have an ileostomy or colostomy with a diameter of 33 mm or less
• Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
• Are evaluated to be suitable for a soft convex product
• If having a colostomy: changes their product on average 2 times pr. 24h or more
• Currently uses a bag of size medi/midi or maxi

Exclusion Criteria

• Have a loop ostomy (also called double-barrel or ostomy with two outlets).
• Are pregnant or breastfeeding
• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Known hypersensitivity toward any of the test products
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestine with water)
• Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
• If subject has a colostomy: empties the bag

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Own product	Coloplast Test	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either 1. Coloplast Test 2. Competitor soft convex
First Coloplast Test	Own product	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either 1. Own product (baseline) 2. Competitor soft convex
First Own product	Competitor soft convex	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either 1. Coloplast Test 2. Competitor soft convex
First Competitor soft convex	Coloplast Test	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either 1. Own product (baseline) 2. Coloplast Test
First Coloplast Test	Coloplast Test	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either 1. Own product (baseline) 2. Competitor soft convex
First Coloplast Test	Competitor soft convex	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either 1. Own product (baseline) 2. Competitor soft convex
First Competitor soft convex	Competitor soft convex	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either 1. Own product (baseline) 2. Coloplast Test
First Own product	Own product	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either 1. Coloplast Test 2. Competitor soft convex
First Competitor soft convex	Own product	The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either 1. Own product (baseline) 2. Coloplast Test

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	14 +/- 3 days	The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.

Trial Locations

Locations (1)

TFS; 🇩🇰 Søborg, Denmark