Evaluation of a New Supporting Ostomy Product
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.
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 May 2020
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 5, 2020
April 1, 2020
7 months
April 29, 2020
May 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Wear time
To evaluate the subject change pattern (wear time) when using the supporting product in 'real-life' situations'
9 weeks
Study Arms (1)
Experimental
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than three months
- Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
- Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm)
- Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
- Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
- Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods
- Have self-reported problems with leakage\* (three times within 14 days) \*Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)
You may not qualify if:
- Currently receiving or have within the past 2 month 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
- Are pregnant or breastfeeding
- Known sensitivity towards test product
- Known sensitivity towards acrylate
- Users with a pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, 3050, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 5, 2020
Study Start
May 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
May 5, 2020
Record last verified: 2020-04