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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05036525

Enrollment

100

Registered

2021-09-05

Start date

2022-06-17

Completion date

2023-04-17

Last updated

2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesion, Thyroid Diseases

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.

Interventions

DEVICEHANBIO BarriGel

an anti-adhesive product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Dysphagia Handicap Index (DHI)	Preoperative 6 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026