NCT03293186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3.5 years

First QC Date

August 18, 2017

Last Update Submit

March 15, 2021

Conditions

AdhesionThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Use MEDICLORE

EXPERIMENTAL

use mediclore at the end of surgery

Combination Product: MEDICLORE

No antiadhesive product

NO INTERVENTION

use no antiadhesive product at the end of surgery

Interventions

MEDICLORECOMBINATION_PRODUCT

use MEDICLORE at the end of surgery as antiadhesive product

Use MEDICLORE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 18, 2017

First Posted

September 26, 2017

Study Start

July 1, 2017

Primary Completion

December 27, 2020

Study Completion

December 31, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)