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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03000881 |
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Date of registration:
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20/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Influence of Output on Skin Covered by Adhesives
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Scientific title:
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Date of first enrolment:
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December 2016 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03000881 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Lene F Nielsen, M. Sc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of preclinical department |
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Key inclusion & exclusion criteria
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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 adhesive strips
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 -
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ileostomy - Stoma
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Intervention(s)
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Other: New adhesive strip
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Other: standard adhesive
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Primary Outcome(s)
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Trans Epidermal Water Loss
[Time Frame: 8 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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