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

Sponsor
HAN Biomedical Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05036525
Collaborator
(none)
100
2
15

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: HANBIO BarriGel
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
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.
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: use HANBIO BarriGel

Device: HANBIO BarriGel
an anti-adhesive product

No Intervention: No anti-adhesive product

Outcome Measures

Primary Outcome Measures

  1. Dysphagia Handicap Index (DHI) [Preoperative 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • HAN Biomedical Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HAN Biomedical Inc
ClinicalTrials.gov Identifier:
NCT05036525
Other Study ID Numbers:
  • HAN2013001-CT02
First Posted:
Sep 5, 2021
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022