A Pilot Evaluation of Adhesives and How They Are Impacted by Output
Not Applicable
Completed
- Conditions
- Ileostomy
- Interventions
- Other: adhesive strip
- Registration Number
- NCT02626260
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The study investigates the impact real output has on the adhesion of adhesives.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1b adhesive strip The subject test one adhesive strip on the peristomal area
- Primary Outcome Measures
Name Time Method Remaining adhesive area of adhesive 30 hours 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
Name Time Method
Trial Locations
- Locations (1)
Coloplast A/S
🇩🇰Humlebaek, Denmark