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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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17 August 2015 |
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Main ID: |
NCT02518035 |
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Date of registration:
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05/08/2015 |
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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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Silicone Gel to Improve Scar in Microtia Patients
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Scientific title:
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Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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32 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02518035 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chun-Shin Chang, M.D.; M.S. |
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Address:
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Telephone:
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886975365538 |
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Email:
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frankchang@cgmh.org.tw |
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Affiliation:
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Name:
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Chun Shin Chang, M.D. |
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Address:
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Telephone:
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886975365538 |
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Email:
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frankchang@cgmh.org.tw |
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Affiliation:
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Name:
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Zung-Chung Chen, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Gung Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with microtia.
- Written informed consent given by parent/guardian.
Exclusion Criteria:
- Combined other craniofacial anomalies
- Without permission of parent/guardian, without signed informed consent by
parent/guardian.
Age minimum:
9 Years
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Microtia
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Scar
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Intervention(s)
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Drug: Silicone Gel
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Primary Outcome(s)
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Scar width
[Time Frame: 6 months after surgery]
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Secondary Outcome(s)
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Visual Analogue Scale
[Time Frame: 6 months after surgery]
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Vancouver Scar Scale
[Time Frame: 6 months after surgery]
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Secondary ID(s)
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103-2849B
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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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