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COMPLETEDNA

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

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.

NCT05036525•HAN Biomedical Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (5)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Key Dates

Start Date

June 17, 2022

Primary Completion Date

April 17, 2023

Completion Date

April 17, 2023

Last Updated

March 5, 2024

Enrollment

100

ACTUAL participants

Conditions

AdhesionThyroid Diseases

Interventions

HANBIO BarriGel

DEVICE

Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women

Ultrasound-Guided Multiple Saline Injections for Prevention of Tendon Adhesion: A Randomized Controlled Trial

Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients with Leukocyte Adhesion Deficiency Type II