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

HAN Biomedical

Status

Completed

Conditions

Thyroid Diseases

Adhesion

Treatments

Device: HANBIO BarriGel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05036525

HAN2013001-CT02

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No 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.
Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.