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

A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02909270

Enrollment

172

Registered

2016-09-21

Start date

2016-08-31

Completion date

Unknown

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Thyroidecomy (Scheduled)

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

DEVICEMediclore

to apply mediclore fully around thyroid gland

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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 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

Design outcomes

Primary

Measure	Time frame
adhesion incidence rate following 8 weeks	8 weeks

Countries

South Korea

Contacts

Primary ContactWan Huh

whuh408@daewoong.co.kr+82-2-550-8106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026