NCT02967146Unknown3 期
Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- sum of ROM(range of motion)
研究概览
简要总结
Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer
详细描述
A Multicenter Double-blinded, Randomized Study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients needed axillary dissection in breast cancer
- •Written informed consent
- •Patients without clinically significant lab
- •the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy
排除标准
- •having enrolled another clinical trials within 1 month
- •Immunosuppression or autoimmune disease
- •Anticoagulant, general steroids within a week from surgery
- •Incompatible medications
- •Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
结局指标
主要结局
sum of ROM(range of motion)
时间窗: 4weeks
to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
次要结局
- pain assessment (numeric pain rating scale)(4weeks, 24weeks)
- sum of ROM(range of motion)(24weeks)
- Scoring DASH(Disablities of the arm, shoulder and hand)(4weeks, 24weeks)
研究者
Seok Won Kim
MD
Samsung Medical Center
研究点 (2)
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