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Completed

NCT Number: NCT03293186

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

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.

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Key information

Conditions

Adhesion Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thyroidectomy Tissue Adhesions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDICLORE

Combination Product

use MEDICLORE at the end of surgery as antiadhesive product

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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