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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2023-04-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Adhesion Thyroid Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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use HANBIO BarriGel

Group Type EXPERIMENTAL

HANBIO BarriGel

Intervention Type DEVICE

an anti-adhesive product

No anti-adhesive product

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HANBIO BarriGel

an anti-adhesive product

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No