Status:
COMPLETED
Evaluation of the Performance of an Adhesive Strip
Lead Sponsor:
Coloplast A/S
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study investigated the performance of a new adhesive strip when impacted by output
Eligibility Criteria
Inclusion
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had an ileostomy for more than one year
- Have intact skin on the area used in the evaluation
- Has an ileostomy with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of test product (assessed by investigator)
Exclusion
- 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
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
- Participating in other interventional clinical investigations or have previously participated in this investigation
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03419013
Start Date
January 10 2018
End Date
January 22 2018
Last Update
February 1 2018
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, 3050