Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
NCT ID: NCT02909270
Last Updated: 2016-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
172 participants
INTERVENTIONAL
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Mediclore
adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy
Mediclore
to apply mediclore fully around thyroid gland
No treatment
No treatment, standard treatment for thyroidectomy
No interventions assigned to this group
Interventions
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Mediclore
to apply mediclore fully around thyroid gland
Eligibility Criteria
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Inclusion Criteria
* Male or female at least 20 years of age
* Patients without clinically significant lab
* Patients scheduled for thyroidectomy
Exclusion Criteria
* History of previous surgery on same position
* Anticoagulant, general steroids within a week from surgery
* Immunosuppression or autoimmune disease
* General or local infection
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertentsion, diabetes mellitus, coagulation deficiencies)
* Incompatible medications
* History of drug or alcohol abuse, mental disorder
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* History of esophagus diseases
* Keloid symptoms
20 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CG-AHS004
Identifier Type: -
Identifier Source: org_study_id
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