Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
Phase 3
- Conditions
- Patients With Thyroidecomy (Scheduled)
- Interventions
- Device: Mediclore
- Registration Number
- NCT02909270
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 172
Inclusion Criteria
- Written informed consent
- Male or female at least 20 years of age
- Patients without clinically significant lab
- Patients scheduled for thyroidectomy
Exclusion Criteria
- Another clinical trials within 1 month
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediclore Mediclore adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy
- Primary Outcome Measures
Name Time Method adhesion incidence rate following 8 weeks 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ajou University Hospital
🇰🇷Su won, Gyeonggi-do, Korea, Republic of