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

Primary Purpose

Adhesion, Thyroidectomy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MEDICLORE
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adhesion

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Use MEDICLORE

No antiadhesive product

Arm Description

use mediclore at the end of surgery

use no antiadhesive product at the end of surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 18, 2017
Last Updated
March 15, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03293186
Brief Title
Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)"
Official Title
Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" by Using Double-blind Test in Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 27, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesion, Thyroidectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use MEDICLORE
Arm Type
Experimental
Arm Description
use mediclore at the end of surgery
Arm Title
No antiadhesive product
Arm Type
No Intervention
Arm Description
use no antiadhesive product at the end of surgery
Intervention Type
Combination Product
Intervention Name(s)
MEDICLORE
Intervention Description
use MEDICLORE at the end of surgery as antiadhesive product
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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