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

Not Applicable

Completed

• Conditions: Thyroid Diseases; Adhesion
• Interventions: Device: HANBIO BarriGel

• Registration Number: NCT05036525
• Lead Sponsor: HAN Biomedical Inc

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-05
• Study Start: 2022-06-17
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
use HANBIO BarriGel	HANBIO BarriGel	-

Primary Outcome Measures

Name	Time	Method
Dysphagia Handicap Index (DHI)	Preoperative 6 weeks

Trial Locations

Locations (5)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Keelung Chang Gung Memorial Hospital; 🇨🇳 Keelung, Taiwan