A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Device: Coloplast Test A; Device: Own product; Device: Coloplast Test B; Device: Coloplast Test C; Device: Coloplast Test D

• Registration Number: NCT02064231
• 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-17
• Results First Submitted: 2014-02-25
• Results First Submitted QC: 2014-02-25
• Results First Posted: 2014-04-04
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Had given written informed consent
2. Was at least 18 years of age
3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
4. Had an ileostomy with a diameter between 15-45 mm
5. Have had an ileostomy for at least 3 months
6. Currently used a 2-piece flat appliance

Exclusion Criteria

1. Used irrigation during the investigation (flush stoma with water)
2. Currently received or had within the past 2 months received radio- and/or chemotherapy.
3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
4. Was pregnant or breast feeding
5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
6. Had a baseplate wear time of more than three days
7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coloplast Test A, Coloplast Test B, Own product	Coloplast Test A	The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test C , Coloplast Test D, Own product	Own product	The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
Coloplast Test C , Coloplast Test D, Own product	Coloplast Test D	The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
Coloplast Test A, Coloplast Test B, Own product	Own product	The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test A, Coloplast Test B, Own product	Coloplast Test B	The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test C , Coloplast Test D, Own product	Coloplast Test C	The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days

Primary Outcome Measures

Name	Time	Method
Degree of Leakage	14 days	Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).