CompletedInterventionalNot ApplicableUpdated May 31, 2017
Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5) | NCT02992444 | Trialant
CompletedInterventionalNot ApplicableUpdated Aug 28, 2025
Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)
ClinicalTrials.gov ID
NCT02992444
Lead Sponsor
Coloplast A/SINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
5Actual
Last Update Posted
Aug 28, 2025Actual
Start Date
Dec 2016Actual
Primary Completion Date
Dec 2016Actual
Completion Date
Dec 2016Actual
Brief Summary
This study investigates the impact real output has on peristomal skin covered by an adhesive
Ileostomy - Stoma
Standard adhesive strip
Experimental adhesive strip
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 patches/adhesive strips (assessed by investigating scientist)
Exclusion Criteria:
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 investigating scientist)
Participating in other interventional clinical investigations or have previously participated in this evaluation