Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Drainage volume discharge
研究概览
简要总结
The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing lavages with normal saline (Group 1), patients undergoing lavage gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution (Group 3). Drainage volume discharge is investigated
详细描述
The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing 2 lavages with 500 ml normal saline (Group 1), patients first undergoing lavage with 500 ml normal saline followed by a second lavage with a 500 ml of a gentamicin (240 mg) solution (Group 2) and patients first undergoing lavage with 500 ml normal saline followed by a second lavage with 500ml of a clindamycin (600mg) solution (Group 3). Drainage volume discharge is investigated
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of breast neoplasms
- •plans to undergo an elective ALND of Berg's levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis.
排除标准
- •allergy to any of the antibiotic drugs used
- •chronic renal failure due to possible toxicity of gentamicin
- •patients undergoing a modified radical mastectomy.
研究组 & 干预措施
Irrigation with Gentamicin solution
The surgical bed is irrigated with a gentamicin solution
干预措施: Irrigation with gentamicin solution (Drug)
Irrigation with Clindamycin solution
The surgical bed is irrigated with a clindamycin solution
干预措施: Irrigation with Clindamycin solution (Drug)
Irrigation with Normal saline
The surgical bed is irrigated with normal saline
干预措施: Irrigation with Normal saline (Drug)
结局指标
主要结局
Drainage volume discharge
时间窗: 14 days
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Medicine Doctor
Hospital General Universitario Elche