Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.

Study Overview
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Brief Summary
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The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions

Detailed Description
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The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.

Official Title
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Evaluation of the Efficacy and Safety of a High Molecular Weight Native Hyaluronic Acid Gel (HANBIO BarriGel) in Adhesion Prevention After Open Thyroidectomy: a Prospective, Randomized Controlled, Single Blind Study.

Conditions
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Adhesion, Thyroid Diseases

Intervention / Treatment
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* Device: HANBIO BarriGel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female between 20 and 70 years of age. Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection). Naïve patients to thyroid surgery. Subjects are willing to comply with all aspects of the study and have signed informed consent form. Exclusion Criteria: Pregnant or lactating female patients. Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse. Patients with previous neck radiotherapy within 1 year. Concurrent diseases/conditions which will be unable to evaluate the outcomes. Patients receiving any adhesion prevention adjuvant. Previous history of Keloid or hypertrophic scar. Anticoagulant used within a week from surgery. Subjects are hypersensitive to sodium hyaluronate. Participate in another clinical trial within 1 month. Patients presence of surgical site infection. Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: use HANBIO BarriGel<br> | Device: HANBIO BarriGel<br>* an anti-adhesive product<br>|
| No Intervention: No anti-adhesive product<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia Handicap Index (DHI) |  | Preoperative 6 weeks |