Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.
1 other identifier
interventional
100
1 country
5
Brief Summary
The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2023
CompletedMarch 5, 2024
March 1, 2024
10 months
September 2, 2021
March 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Dysphagia Handicap Index (DHI)
Preoperative 6 weeks
Study Arms (2)
use HANBIO BarriGel
EXPERIMENTALNo anti-adhesive product
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2021
First Posted
September 5, 2021
Study Start
June 17, 2022
Primary Completion
April 17, 2023
Study Completion
April 17, 2023
Last Updated
March 5, 2024
Record last verified: 2024-03