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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ileostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Coloplast Test A

Device

Coloplast Test A is a new ostomy appliance developed by Coloplast A/S

Coloplast Test B

Device

Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S

Own product

Device

Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.

Coloplast Test C

Device

Coloplast Test C is a new ostomy appliance developed by Coloplast A/S

Coloplast Test D

Device

Coloplast Test D is a new ostomy appliance developed by Coloplast A/S

Primary outcomes

Degree of Leakage

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Feb 17, 2014
Registry last updated: Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed