Evaluating the impact of perioperative systemic tranexamic acid and topical hemocoagulase on reducing axillary drain output and seroma formation in breast cancer patients undergoing axillary lymph node dissection.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- To compare the cumulative axillary drain output measured daily in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection
研究概览
简要总结
This study is a randomized, parallel group, evaluating the impact of perioperative systemic tranexamic acid and topical hemocoagulase on reducing axillary drain output and seroma formation in breast cancer patients undergoing axillary lymph node dissection. The members of Test Group will be receiving injection tranexamic acid (15mg/kg) IV route 30 mins before the induction of anesthesia. After completion of ALND, 4 drops/cm2 of H (strength 0.2 U/mL) are sprayed over the raw surface of the axilla of the test group. Control group receives routine care.Test Group will also receive oral tranexamic acid tablet 500mg thrice daily for the next 5 days and the Control Group will be provided routine medications.The cases will be followed up for a period of 30 days.
The primary outcome is to compare the cumulative axillary drain output measured daily in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection.
The secondary outcomes are :
To compare the day of axillary drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTo compare the incidence of seroma formation after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection
To compare the volume and number of seroma aspirations done in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection
To compare the incidence of Surgical site infection after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection
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 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Cases of breast carcinoma with TNM staging- T-1 T-2 T-3 N-0 N-1 N-2 M-0 Undergoing Modified radical mastectomy and breast conservation surgery.
排除标准
- •1.Cases of Breast Carcinoma with TNM staging T4N3Mo 2.Cases with bilateral Carcinoma breast 3.Cases undergoing palliative mastectomy 4.Cases of breast carcinoma in males 5.Patients with a history of radiation therapy to the axilla, lymphedema of the affected upper limb, clotting disorders, active thromboembolic disease, pregnancy, lactation, or allergic to Tranexamic acid or Hemocoagulase.
- •6.Patients who developed hematoma after surgery.
结局指标
主要结局
To compare the cumulative axillary drain output measured daily in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection
时间窗: 3 years
次要结局
- To compare the day of axillary drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection(3 years)
- To compare the incidence of seroma formation after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection(3 years)
- To compare the volume and number of seroma aspirations done in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection(3 years)
- To compare the incidence of Surgical site infection after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissection(3 years)
研究者
Dr Vigneshwar M
Jawaharlal Institute of Postgraduate Medical Education and Research