NCT05036525已完成不适用
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.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Dysphagia Handicap Index (DHI)
研究概览
简要总结
The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
No anti-adhesive product
No Intervention
use HANBIO BarriGel
Experimental
干预措施: HANBIO BarriGel (Device)
结局指标
主要结局
Dysphagia Handicap Index (DHI)
时间窗: Preoperative 6 weeks
次要结局
未报告次要终点
研究者
研究点 (7)
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