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

Phase 4

Completed

• Conditions: Adhesion; Thyroidectomy
• Interventions: Combination Product: MEDICLORE

• Registration Number: NCT03293186
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-26
• Primary Completion: 2020-12-27
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use MEDICLORE	MEDICLORE	use mediclore at the end of surgery

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of