Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- seroma formation complication incidence
研究概览
简要总结
Axillary dissection is the standard treatment for breast cancer patients with positive nodes. However, seroma formation after axillary dissection remains the most common early complication to breast cancer surgery. It can delay the initiation of adjuvant therapy, predispose to wound infection, delay wound healing and has also been linked to arm lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following axillary dissection and groin dissection, we use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed to evaluate the efficacy, safety and economics benefits of early VAC application on postoperative complications and wound healing after extensive axillary dissection in comparison to conventional suction drain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •patients diagnosed with breast cancer, receiving modified radical mastectomy and axillary dissection；
- •Body Mass Index ≥28；
- •drainage volume within the first 48 hours is more than 200 mL.
排除标准
- •Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes.
- •Subjects having previously had axillary surgery,
- •Subjects having undergone irradiation therapy to the axillary tissue
- •Subjects having ever received chemotherapy before the surgery,
- •Subjects with known hypersensitivity to components of the surgical sticky membrane
研究组 & 干预措施
Axillary dissection
Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
干预措施: Axillary dissection (Procedure)
vacuum assisted closure
Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
干预措施: vacuum assisted closure in experimental arm (Procedure)
结局指标
主要结局
seroma formation complication incidence
时间窗: within the first 30 days (plus or minus 3 days) after surgery
次要结局
未报告次要终点
研究者
Bi-Hongda
attending physician,department of plastic surgery
Changhai Hospital