A Clinical Investigation of New Ostomy Appliances
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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 10, 2014
CompletedMarch 10, 2014
January 1, 2014
2 months
January 10, 2012
November 21, 2013
January 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Leakage Under the Base Plate Using a 24-point Scale
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)
Each product will be tested 2 weeks
Study Arms (2)
test product 1 first
EXPERIMENTALown product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
test product 2 first
EXPERIMENTALown product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
Interventions
test product 1 is tested first
test product 2 is tested first
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, Denmark, 3050, Denmark
Results Point of Contact
- Title
- Marianne Raff
- Organization
- Coloplast A7S
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
February 1, 2012
Study Start
February 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 10, 2014
Results First Posted
March 10, 2014
Record last verified: 2014-01