Status:
COMPLETED
Evaluation of the Performance of a New Adhesive Strip
Lead Sponsor:
Coloplast A/S
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study investigates 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 a stoma for more than one year
- Have intact skin on the area used in the evaluation
- Has a stoma with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist)
Exclusion
- 1 Currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- 3\. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal or abdominal area (assessed by investigating scientist) 5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.
Key Trial Info
Start Date :
August 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03257787
Start Date
August 8 2017
End Date
September 23 2017
Last Update
November 8 2017
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark, 3050