Status:
COMPLETED
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
Lead Sponsor:
Coloplast A/S
Conditions:
Colostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Detailed Description
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with th...
Eligibility Criteria
Inclusion
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be able to handle the bags themselves (application, removal)
- Have a colostomy with a diameter less than 45 mm
- Have had a colostomy for at least 3 months
- Currently use a 1-piece flat ostomy appliance with closed bag
- is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
- Use minimum 1 product per day
- Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
- Have the mental capacity to understand the study and questionnaires
Exclusion
- Use irrigation during the study (flush the stoma with water).
- Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
- Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
- Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
- Are pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01243294
Start Date
August 1 2010
End Date
November 1 2010
Last Update
October 7 2011
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, 3050