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临床试验/NCT01700504
NCT01700504已完成3 期

Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume

Hospital General Universitario Elche1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Drainage volume

研究概览

简要总结

The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.

详细描述

Inclusion criteria will be a diagnosis of mammary neoplasms and 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. Exclusion criteria will be chronic renal failure due to possible toxicity of gentamicin and patients undergoing a modified radical mastectomy.

The patients will be randomized by means of an Internet randomization module into 2 groups: those patients undergoing 2 lavages of the axillary surgical bed with normal saline (Group 1) and those ones first undergoing lavage with normal saline followed by a second lavage with a gentamicin solution (Group 2).

Surgical dissection will be performed using harmonic scalpel (Ultracision, Ethicon Endosurgery, Johnson and Johnson, Cincinnati, OH, USA). Once finished the ALND, a Jackson-Pratt drain will be left in place and connected to a low pressure vacuum device.

Methodology: Irrigation technique and extraction of microbiological samples:

The lavage will be performed immediately prior to closure of the wound, once placed the drainage into the cavity. In both groups, prior to the lavage, a microbiological sample from the surgical bed will be obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline. After aspiration of the saline, a new microbiological sample will be obtained (sample 2). In Group 1 a second lavage with 500 ml normal saline will be performed, while in Group 2 the second lavage will be performed with an antibiotic solution, including gentamicin (240 mg) dissolved in 500 ml normal saline. After aspirating this second lavage, a third microbiological sample will be obtained in the same way as the two previous ones, in both groups (sample 3).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of mammary neoplasms and 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

  • chronic renal failure due to possible toxicity of gentamicin
  • patients undergoing a modified radical mastectomy.

研究组 & 干预措施

Gentamicin lavage

Experimental

Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution

干预措施: Axillary lavage with gentamicin solution (Drug)

Normal saline lavage

Active Comparator

Patients undergoing 2 axillary lavages with 500ml of normal saline

干预措施: Axillary lavage with gentamicin solution (Drug)

结局指标

主要结局

Drainage volume

时间窗: 7 days

The drainage volumen between groups (interventional and control)will be analyzed.

次要结局

未报告次要终点

研究者

发起方
Hospital General Universitario Elche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Ruiz-Tovar, MD, PhD

Associate Professor Universidad Miguel Hernandez

Hospital General Universitario Elche

研究点 (1)

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