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

Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" by Using Double-blind Test in Thyroid Surgery

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 Overview

• Status: Completed
• Conditions: Adhesion; Thyroidectomy
• Intervention / Treatment: Combination product: MEDICLORE

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Use MEDICLORE; use mediclore at the end of surgery	Combination product: MEDICLORE; use MEDICLORE at the end of surgery as antiadhesive product
NO_INTERVENTION: No antiadhesive product; use no antiadhesive product at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.	Participants will be followed from the operation to postoperative 2weeks, 3months, 6months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): December 27, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: SNUHthyroid2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No