Different Methods of Tranexamic Acid Application in Controlling Perio Operative Bleeding in Gynecomastia
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Intraoperative blood loss during liposuction in milliliters
研究概览
简要总结
Different Methods of Tranexamic Acid Application in Controlling Peri-Operative Bleeding in Gynecomastia Surgery
详细描述
The term "gynecomastia" is derived from the Greek words "gyne" = woman and "mastos" = breast and is a benign enlargement of the male breast. It is the most common condition affecting the male breast due to enlargement of both ductal and stromal tissue[1].
Plastic surgeons frequently perform gynecomastia operations as cosmetic procedures. Since these operations result in relatively little blood loss, there is little information in the literature about how to minimise blood loss during these cosmetic procedures Some preventive measure against bleeding and hematomas include perioperative blood pressure control, use compressive dressing, different types of suction drains, size of incision, careful hemostasis, and infusion of adrenalin during local anesthesia, infusion of tranexamic acid in tumescent or intravenous directly
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age (16 - 45 years)
- •Any grade of gynecomastia well be included
排除标准
- •Age (<16 - >40 years)
- •History of previous gynecomastia surgery
- •Patients with known allergy to tranexamic acid
- •Patients with abnormal coagulation profile (according to American Society of Anesthesiologists guidelines for preoperative preparation of surgical patients)
- •Patients who are receiving treatment for known hyper-coagulable state.
- •Patients with history of cardiac disease or thromboembolic events.
研究组 & 干预措施
Tumescent solution only (Control group)
"The operative site will be injected with a standard tumescent solution prepared by adding 20ml of 2% lignocaine and 1ml of 1 in 1000 adrenaline to 500 ml of ringer lactate. No tranexamic acid will be used in this group."
- All patients will undergo suction-assisted liposuction through an infra-areolar incision, followed by glandular excision using the orange peel excision technique. The surgical intervention will be performed as a day-care procedure. Patients will wear pressure garments continuously for 3 days post-operatively and intermittently and by the 3rd day we estimate the ecchymosis in the chest area then pressure garment will be reapplied for 7 to 10 days. Follow-up evaluations will be conducted immediately post-op, at 10 days.
干预措施: Tranexamic acid injection (Drug)
Tumescent solution with tranexamic acid added
"The operative site will be injected with a tumescent solution prepared as in Group A (Control group), with the addition of 500 mg tranexamic acid to the tumescent solution."
- All patients will undergo suction-assisted liposuction through an infra-areolar incision, followed by glandular excision using the orange peel excision technique. The surgical intervention will be performed as a day-care procedure. Patients will wear pressure garments continuously for 3 days post-operatively and intermittently and by the 3rd day we estimate the ecchymosis in the chest area then pressure garment will be reapplied for 7 to 10 days. Follow-up evaluations will be conducted immediately post-op, at 10 days.
干预措施: Tranexamic acid injection (Drug)
Tumescent solution with intravenous tranexamic acid
The standard tumescent solution as in the control group, with 500 mg tranexamic acid administered intravenously ( well-injected IV directly).
- All patients will undergo suction-assisted liposuction through an infra-areolar incision, followed by glandular excision using the orange peel excision technique. The surgical intervention will be performed as a day-care procedure. Patients will wear pressure garments continuously for 3 days post-operatively and intermittently and by the 3rd day we estimate the ecchymosis in the chest area then pressure garment will be reapplied for 7 to 10 days. Follow-up evaluations will be conducted immediately post-op, at 10 days.
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
Intraoperative blood loss during liposuction in milliliters
时间窗: "Intraoperatively" Unit of Measure: Milliliters (mL)
The volume of blood collected in the liposuction bottle during the surgical procedure will be measured. This will be reported as mean volume in milliliters with standard deviation for each study group.
次要结局
- Change in hemoglobin concentration from baseline to 24 hours post-operation(Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Grams per deciliter (g/dL))
- Changes in coagulation profile at 24 hours post-operation("Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Seconds for PT and aPTT, no units for INR)
- Extent of post-operative ecchymosis at 7 days("7 days post-operation" Unit of Measure: Ordinal scale score (0-4))
- Duration of surgical drain placement in days(From immediate post-operation until drain removal (expected within 3 to 7 days)" Unit of Measure: Days)
研究者
Amjad Ahmed Qasim AL-Gubari
Resident of Plastic Surgery, Department of Plastic and Reconstructive Surgery
Assiut University