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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Adhesion; Thyroidectomy

Treatments: Combination Product: MEDICLORE

Study type: Interventional

Funder types: Other

Identifiers

NCT03293186

SNUHthyroid2

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Use MEDICLORE

Experimental group

Description:

use mediclore at the end of surgery

Treatment:

Combination Product: MEDICLORE

No antiadhesive product

No Intervention group

Description:

use no antiadhesive product at the end of surgery