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OpenTrials
Completed

NCT Number: NCT01523756

A Clinical Investigation of New Ostomy Appliances

This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

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Key information

Conditions

Leakage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, Denmark, 3050

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years.
  • Have had an ileostomy for more than 3 months.
  • Have used convex products for the last 1 month.
  • Has given written Informed Consent.
  • Have an ileostomy with a diameter between 15 and 33 mm.
  • Have inward peristomal area

Exclusion criteria

  • Have loop ostomy
  • Pregnant or breastfeeding.
  • Known allergy towards any of the product components or ingredients.
  • Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
  • Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
  • Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)

Treatment and study plan

test product 1: new ostomy base plate with Coloplast as manufacturer

Device

test product 1 is tested first

test product 2: new ostomy base plate with Coloplast as manufacturer

Device

test product 2 is tested first

Primary outcomes

  1. Leakage Under the Base Plate Using a 24-point Scale

    Time frame: Each product will be tested 2 weeks

    Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2012
Registry last updated
Mar 10, 2014

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.

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