Patients With Thyroidectomy (Scheduled)
Conditions
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
Interventions
Sponsors
Study design
Eligibility
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 hypertension, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adhesion incidence rate following 8 weeks | 8 weeks |
Countries
South Korea