An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.

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Key information

Conditions

Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Have given written informed consent and letter of authority
Be at least 18 years of age and have full legal capacity
Be able to handle the products her/himself
Have an ileostomy with a diameter between 10 and 30 mm
Willing to follow the product change schedule (one change per day)
Have had their ostomy for at least three months
Willing to use 1 piece open ostomy products during the test period
Must be able to use a custom cut product
Have intact skin
Negative result of a pregnancy test for women of childbearing age

Exclusion criteria

Currently receiving or have within the past 2 months received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
Is pregnant or breastfeeding.
Is participating in other interventional clinical investigations or have previously participated in this investigation
Have a loop ileostomy
Known hypersensitivity towards any of the test products

Treatment and study plan

Test A

Device

Ostomy appliance

Test B

Device

Ostomy appliance

Baseline

Device

Ostomy appliance

Primary outcomes

Product Acceptance

Time frame: 7 days per test period

Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.

There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.

The result presented below shows how many subjects preferred Test A/Test B over own product

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jan 30, 2015
Registry last updated: Jan 6, 2016

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