跳至主要内容
临床试验/NCT04730674
NCT04730674已完成不适用

Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.

Zagazig University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
The number of injection sessions to reach complete resolution of seroma

研究概览

简要总结

female patients with established diagnosis of post-mastectomy seroma following modified radical mastectomy, were treated by local injection of tetracycline after the seroma fluid was aspirated, then a crepe bandage was applied over the mastectomy area. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications. The amount of seroma aspirated in each session.

详细描述

In this study, 18 patients with established diagnosis of post-mastectomy seroma were included. All of them were females undergoing modified radical mastectomy where seroma appeared after drain removal.

The age, co-morbidities, total leukocytic count (as an indicator of infection), serum albumin and tumour size and pathology for all of them were recorded. Then we interfered with our tetracycline injection technique for the treatment of seroma.

All the patients were consented regarding this therapeutic technique explaining the expected possible occurrence of some pain during and after injection, other complications like wound infection or flap necrosis necessitating further intervention. Moreover, repetition of the technique may be needed

In our technique the following was adopted:

  1. First, the seroma fluid was aspirated completely using a 20 cc syringe while the patient lying flat and the needle inserted in the most dependent area
  2. Then, 10 cc of saline containing 2 gm of tetracycline mixed with 5 ml of 2% xylocaine (as a pain relieving agent) was injected at the seroma bed.
  3. After completion of injection, a crepe bandage was applied over the mastectomy area (flaps covering the seroma bed)
  4. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications as infection or flap necrosis. If there were any re-collection, the tetracycline injection procedure would be repeated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • any patient with post-mastectomy seroma following modified radical mastectomy after removal of drain
  • no signs of infection or flap necrosis

排除标准

  • patients with post-mastectomy seroma following modified radical mastectomy with drain still in
  • if signs of infection or flap necrosis present

研究组 & 干预措施

post-mastectomty seroma group

Experimental

female patients with established diagnosis of post-mastectomy seroma following modified radical mastectomy, were treated by local injection of tetracycline after the seroma fluid was aspirated, then a crepe bandage was applied over the mastectomy area. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications. The amount of seroma aspirated in each session.

干预措施: tetracycline mixed with xylocaine (Drug)

结局指标

主要结局

The number of injection sessions to reach complete resolution of seroma

时间窗: 5 days

number of injection sessions to reach complete resolution of seroma

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Joseph Rizk Awad

lecturer of surgery, faculty of human medicine

Zagazig University

研究点 (1)

Loading locations...

相似试验

Predictive Factors Affecting the Efficacy of Local... | 临床试验