Contrast The Role of Microfibrillar Collagen Hemostat Flour（Avitene） And OK-432 （Sapylin）in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- postoperative drainage magnitude
研究概览
简要总结
After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma formation and it can not be ignored.Investigators aimed to study two new methods of application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation and to verify the efficacy and safety of these two applications.Try to prove them as beneficial supplements for axillary lymphadenectomy of breast cancer.
详细描述
A prospective,randomized analysis of breast-conserving surgery or mastectomy plus axillary lymphadenectomy for those patients with sentinel node positive using Microfibrillar Collagen Hemostat Flour 、 OK-432 or using nothing in equal probability.Up to 12 months,a total of 180 will be recruited in plan.During the operation and after the axillary lymphadenectomy，according the arms，Investigators put Microfibrillar Collagen Hemostat Flour（avitene）、 OK-432（Sapylin） or nothing into patients axillary wounds。And Investigators will the statistical significance of these three arms that the postoperative drainage magnitude and duration.Also the complications associated with axillary lymphadenectomy will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
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
- •Patients volunteered for the study and signed informed consent；
- •Preoperative biopsy or intraoperative sentinel lymph node biopsy confirmed axillary lymph node metastasis and need axillary lymphadenectomy
- •No penicillin allergy
- •No blood system diseases
- •No rheumatic heart disease
- •No history or family history of asthma
- •No history of axillary surgery
排除标准
- •A history of severe hypertension
- •A history of diabetes
- •Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year
- •Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment
研究组 & 干预措施
Avitene,Drainaging,reexamine
干预措施: Avitene (Drug)
Avitene,Drainaging,reexamine
干预措施: axillary drainage (Behavioral)
Avitene,Drainaging,reexamine
干预措施: reexamine (Other)
Sapylin,Drainaging,reexamine
干预措施: Sapylin (Drug)
Sapylin,Drainaging,reexamine
干预措施: axillary drainage (Behavioral)
Sapylin,Drainaging,reexamine
干预措施: reexamine (Other)
Drainaging,reexamine
干预措施: axillary drainage (Behavioral)
Drainaging,reexamine
干预措施: reexamine (Other)
结局指标
主要结局
postoperative drainage magnitude
时间窗: up to 1 year
次要结局
- Duration of the drainage(up to 1 year)
研究者
Jia Weijuan
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University