A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put | NCT02610907 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 20, 2016
A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
ClinicalTrials.gov ID
NCT02610907
Lead Sponsor
Coloplast A/SINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
4Actual
Last Update Posted
Jan 20, 2016Estimated
Start Date
Nov 2015
Primary Completion Date
Jan 2016Actual
Completion Date
Jan 2016Actual
Brief Summary
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.
Ileostomy
Buffer
Own output
simulated output
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