跳至主要内容
临床试验/CTRI/2024/07/071644
CTRI/2024/07/071644尚未招募2/3 期

Evaluation of seroma formation after Modified Radical Mastectomy using single vs double drain : a Randomized Controlled Trial

Postgraduate Institute of Medical Education and Research Chandigarh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Total duration of drain kept insitu

研究概览

简要总结

Evaluation of seroma formation after Modified Radical Mastectomy using single vs double drain. Two groups are made based on computer generated randomisation. Modified radical mastectomy done . In one group of patient, one drain placed only at the axilla. In other group, two limbs of drain is placed, one under the skin flap , other in the axilla. Seroma formation will be evaluated on the basis of drain output and number of days the drains is kept in situ. Other outcomes being evaluated are flap necrosis, surgical site infections which are all complications of seroma formation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patients who have biopsy proven breast cancer who are scheduled for Modified Radical Mastectomy and give valid informed consent for the study.

排除标准

  • Patients who will undergo breast conservative surgery 2)Male patients with BC.

结局指标

主要结局

Total duration of drain kept insitu

时间窗: Till 4 weeks

次要结局

  • To look for flap necrosis(Till 4 weeks)
  • To look for surgical site infections(Till 4 weeks)
  • Pain at drain site(Till drain is insitu)

研究者

发起方
Postgraduate Institute of Medical Education and Research Chandigarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SRIJITA SAHA

Post Graduate Institute of Medical Education and Research Chandigarh

研究点 (1)

Loading locations...

相似试验