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

Thyroid Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036525
• Other study ID #: HAN2013001-CT02
• Status: Completed
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: March 2024
• Source: HAN Biomedical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesion
• Thyroid Diseases
• Tissue Adhesions

Intervention

Device:
• HANBIO BarriGel
an anti-adhesive product

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
HAN Biomedical Inc

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia Handicap Index (DHI)		Preoperative 6 weeks