Status:

COMPLETED

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

Lead Sponsor:

Seoul National University Hospital

Conditions:

Adhesion

Thyroidectomy

Eligibility:

All Genders

20-70 years

Phase:

PHASE4

Brief 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 prospect...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2020

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT03293186

Start Date

July 1 2017

End Date

December 31 2020

Last Update

March 17 2021

Active Locations (1)

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Seoul National University Hospital

Seoul, South Korea, 110-744