跳至主要内容
临床试验/CTRI/2024/11/077411
CTRI/2024/11/077411尚未招募不适用

A Comparative Study Of Using Tranexamic Acid Versus Botropase Reducing postoperative Bleeding And seroma Formation Following Modified Radical Mastectomy

Dr Medagani Bhargav1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To study the effect of tranexamic acid and botropase in reduction of

研究概览

简要总结

The patients who meet the inclusion criteria will be included in the study and will receive Inj.Tranexamic acid first dose (1gm IV in 100ml Normal Saline) initially at the the time of induction of anesthesia, followed by oral tab Tranexamic acid 500mg 8 hourly for 5 days from POD1. These patients will be labelled as Group A and will be operated in the same unit in the surgery department. Breast cancer patients who are operated in other units in the department will receive Inj.botropase 2ml intravenously at the time of induction of anesthesia and followed by 2 ml intra venously 12 hourly for 5 days and will be labelled as group B. Demographic data and following data will be collected and will be analysed for the following parameters. 1 Post operative bleeding-will be measured clinically through drain placed intraoperatively or by USG guidance if needed. 2 Seroma formation- will be measured clinically through the intraoperative drain and through USG if needed. 3 Postoperative wound healing time-will be calculated from POD 1 and we will count the number of days the wound takes to heal completely and it will be assessed clinically. 4 Postoperative hospital stay- we will count the number of days the patient takes to get discharged. 5 Post operative wound infection – wound infection will be assessed by clinical symptoms like fever, pain, discharge and signs like erythema, local rise of temperature, tenderness and discharge from the wound. 6 Demography and spectrum of patients

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Patients giving informed consent.
  • Female patients with operable breast cancer undergoing modified radical mastectomy of age more than 18 year.

排除标准

  • • Advanced breast cancer patients in which upfront surgery is not indicated.
  • • Known thrombotic disease or high risk of thromboembolism.
  • • Patients on anticoagulants.
  • • Denial of consent.
  • • Pregnant females.
  • • Patients deemed unfit for surgery.

结局指标

主要结局

To study the effect of tranexamic acid and botropase in reduction of

时间窗: 1 week

postoperative bleeding and seroma formation in post Modified radical Mastectomy

时间窗: 1 week

patients

时间窗: 1 week

次要结局

  • To reduce(Postoperative wound healing time.)

研究者

发起方
Dr Medagani Bhargav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Bhargav Medagani

Government Medical College, Haldwani

研究点 (1)

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