NCT03007654Unknown3 期
Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study
Yong Sang Song1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- adhesion rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with Gynecological disease (benign disease)
- •Patients who Written informed consent
- •Patients without clinically significant lab
排除标准
- •having enrolled another clinical trials within 1 month
- •Immunosuppression or autoimmune disease
- •Anticoagulant, general steroids within a week from surgery
- •Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
- •Patients with previous history of surgery at the same operate site
研究组 & 干预措施
Mediclore
Experimental
adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area
干预措施: Mediclore (Device)
No treatment
No Intervention
standard treatment for surgery
Adept
Active Comparator
adhesion barrier, Adept, to apply medical device fully around surgery area
干预措施: Adept (Device)
结局指标
主要结局
adhesion rate
时间窗: 4 weeks after surgery
4 weeks after surgery, finding adhesion using visceral slide test
次要结局
- Incidence of adhesion symptoms(4 weeks after surgery)
- adverse event(4 weeks after surgery)
研究者
Yong Sang Song
MD
Seoul National University Hospital
研究点 (1)
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