Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)"

Seoul National University Hospital90 enrolled

Overview

One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Adhesion Thyroidectomy

Interventions

MEDICLORECOMBINATION_PRODUCT

use MEDICLORE at the end of surgery as antiadhesive product

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * planned to perform thyroidectomy due to thyroid nodule * no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer * normal preoperative vocal cord movement * normal preoperative laboratory study Exclusion Criteria: * uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy * history of keloid or hypertrophic scar * Graves disease or hashimoto thyroiditis patients * aspirin or anticoagulant medication within 7 days * radiation exposure to the head and neck * previous operation to the neck * history of allergic reaction to drugs * pregnant women

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.

Time frame: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months

Data from ClinicalTrials.gov

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