Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
Overview
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: July 4, 2018
Interventions
- Other: test patch
- the test patch consists of an adhesive patch
Arms, Groups and Cohorts
- Experimental: test patch
- two adhesive patches are applied to the abdominal area
Clinical Trial Outcome Measures
Primary Measures
- Resistance (Moisture in the adhesive)
- Time Frame: 3 days
- moisture in adhesive is measured using a measurement probe
Participating in This Clinical Trial
Inclusion Criteria
1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have intact skin on the area used in the evaluation 4. Have an abdominal area accessible for application of test product (assessed by investigator) 5. Negative pregnancy test for fertile women 6. Signed document claiming use of safe contraceptives for fertile women Exclusion Criteria:
1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy 2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator) 5. 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Coloplast A/S
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Lene F Nielsen, Principal Investigator, Head of the pre-clinical department
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