CompletedInterventionalNot ApplicableUpdated May 31, 2017
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives | NCT02886455 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 13, 2016
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
ClinicalTrials.gov ID
NCT02886455
Lead Sponsor
Coloplast A/SINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
4Actual
Last Update Posted
Oct 13, 2016Estimated
Start Date
Sep 2016
Primary Completion Date
Sep 2016Actual
Completion Date
Sep 2016Actual
Brief Summary
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.
Ileostomy - Stoma
Standard adhesive strip
New 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