The Influence of Adhesive Wafer Design… | Clinical Trial

Key information

Conditions

Ostomy - Ileostomy or Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QPS Netherlands, Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:

Have given written informed consent and signed letter of Authority
Be at least 18 years of age and have full legal capacity
Have had their ileostomy or colostomy for at least 3 months
Have a stoma with a diameter between 15 and 43 mm
Be able to handle the product themselves
Be able to use a custom cut product
Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
Currently using a 1-piece flat product or a 1-piece soft convex product
Be willing to test products with open bag size maxi
Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
Be suitable for participating in the investigation
Be willing to take/have taken pictures of the stoma before, during and after application of product

Exclusion criteria

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
Are pregnant or breastfeeding
Are participating in other interventional clinical investigations or have previously participated in this investigation
Use irrigation during the investigation (flush the intestines with water)
Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
Have a loop stoma
Have known hypersensitivity towards any of the test products

Treatment and study plan

Test A

Device

Test A is a new 1-piece ostomy appliance developed by Coloplast A/S

Test B

Device

Test B is a new 1-piece ostomy appliance developed by Coloplast A/S

COMPARATOR

Device

Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.

Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed.

Primary outcomes

Fit to body

Time frame: 14 +/- 2 days

Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?"

The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 27, 2014
Registry last updated: Mar 23, 2015

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.

Recruiting