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NCT03293186 Clinical Trial

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

Thyroidectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03293186
Other study ID # SNUHthyroid2
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 1, 2017
Est. completion date December 31, 2020

Study information
Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 31, 2020
Est. primary completion date December 27, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• MEDICLORE
use MEDICLORE at the end of surgery as antiadhesive product

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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