Back to resultsA Pilot Evaluation of Adhesives and How They Are Impacted by Output
Primary Purpose
Ileostomy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
adhesive strip
Sponsored by
About this trial
This is an interventional basic science trial for Ileostomy
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
Sites / Locations
- Coloplast A/S
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohort 1b
Arm Description
The subject test one adhesive strip on the peristomal area
Outcomes
Primary Outcome Measures
Remaining adhesive area of adhesive
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02626260
Brief Title
A Pilot Evaluation of Adhesives and How They Are Impacted by Output
Official Title
A Pilot Evaluation of Adhesives and How They Are Impacted by Output
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the impact real output has on the adhesion of adhesives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileostomy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1b
Arm Type
Experimental
Arm Description
The subject test one adhesive strip on the peristomal area
Intervention Type
Other
Intervention Name(s)
adhesive strip
Intervention Description
Adhesive strip with a standard adhesive base
Primary Outcome Measure Information:
Title
Remaining adhesive area of adhesive
Description
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area
Time Frame
30 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
Coloplast A/S
City
Humlebaek
ZIP/Postal Code
3050
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Pilot Evaluation of Adhesives and How They Are Impacted by Output
We'll reach out to this number within 24 hrs