Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.
详细描述
A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma between the two groups and the quality of life of the patients is assessed, given that none of them has a drain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Over 18 years old
- •Conservative surgery for breast cancer with associated axillary lymphadenectomy
排除标准
- •Mastectomy
- •History of axillary surgery or ipsilateral axillary radiotherapy
- •ASA 4 patients. (ASA 3 patients selected)
- •Lack of adequate cognitive capacity and/or signed informed consent
- •Pregnancy
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: Up to 1 year
Type and number of adverse events
Change in symptomatic seroma
时间窗: Up tp 1 year
Number of evacuating punctures
次要结局
- Demographic characteristics of patients related to seroma(Up to 1 year)
- Number of patients with temporary or permanence of disability after operation(Up to 1 year)
- Individual's perception of the position in life of the participants(Day 7 and 14 after surgery)
- Seroma volume(Day 7 and 14 after surgery)
- Milliliters of evacuated seroma in case of puncture(7, 14 and 30 day after surgery)
研究者
Sandra Lopez Gordo
Principal investigator
Omphis Foundation