NCT03619226CompletedNot Applicable
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Resistance (Moisture in the Adhesive)
Study Overview
Brief Summary
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have intact skin on the area used in the evaluation
- •Have an abdominal area accessible for application of test product (assessed by investigator)
- •Negative pregnancy test for fertile women
- •Signed document claiming use of safe contraceptives for fertile women
Exclusion Criteria
- •Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
- •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 investigator)
- •Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation
Arms & Interventions
test patch
Experimental
two adhesive patches are applied to the abdominal area
Intervention: test patch (Other)
Outcomes
Primary Outcomes
Resistance (Moisture in the Adhesive)
Time Frame: 3 days
The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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