NCT02141373Unknown不适用
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Total drainage volume
研究概览
简要总结
Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The Patient should be above 18 years old
- •The Patients has Node positive breast cancer
- •The Patient is eligible for axillary dissection in addition to a surgical intervention for the primary tumor
- •Patients whose sentinel lymph nodes test positive during surgery.
- •The patient is willing to sign an informed consent to participation
排除标准
- •Platelet count is less than 100000
- •Obese patients with a BMI of more than 35
- •Patients who need immediate breast reconstruction surgery
- •Patients who are receiving anticoagulation therapy or have coagulation disorders
- •Pregnant or lactating patients
- •Patients who are on steroid therapy
- •Patients who received chest radiotherapy
- •Patients who received neoadjuvant chemotherapy
结局指标
主要结局
Total drainage volume
时间窗: 3 months
Total seroma aspirate volume
时间窗: 3 months
次要结局
- Time to drain removal(3 months)
- Number of seroma aspirations(3 months)
- Adverse events(3 months)
- Duration of fluid drainage(3 months)
- Additional costs incurred due to the need of aspirations(3 months)
研究者
Mahmoud Al-Masri
Chairman, Department of Surgery
King Hussein Cancer Center
研究点 (2)
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