Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

CGBio

Status and phase: Unknown; Phase 3

Conditions: Patients With Thyroidectomy (Scheduled)

Treatments: Device: Mediclore® (adhesion barrier)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02940210

CG-AHS004

Details and patient eligibility

About

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

Enrollment: 172 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

Mediclore®

Experimental group

Description:

adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy

Treatment:

Device: Mediclore® (adhesion barrier)

No treatment

No Intervention group

Description:

No treatment, standard treatment for thyroidectomy