CompletedInterventionalNot ApplicableUpdated Nov 8, 2017
An Exploratory Study Investigating Adhesive Reaction to Output | NCT02594085 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 20, 2016
An Exploratory Study Investigating Adhesive Reaction to Output
ClinicalTrials.gov ID
NCT02594085
Lead Sponsor
Coloplast A/SINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
15Actual
Last Update Posted
Jan 20, 2016Estimated
Start Date
Oct 2015
Primary Completion Date
Jan 2016Actual
Completion Date
Jan 2016Actual
Brief Summary
The objective is to investigate the impact that faecal output has on adhesives.
Ileostomy
Patch 1
Patch 2
Patch 3
Patch 4
patch 5
Patch 6
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 3 months
Have intact skin on the area used in the evaluation
Has an ileostomy with a diameter (≤) 35mm
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 area
Convex user
Participate in other interventional clinical investigations