Different Methods of Tranexamic Acid Application in Controlling Peri Operative Bleeding in Gynecomastia Surgery

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Pharmacological-Aggravated Urticaria

Treatments: Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06509256

plastic surgery department

Details and patient eligibility

About

Different Methods of Tranexamic Acid Application in Controlling Peri-Operative Bleeding in Gynecomastia Surgery

Full description

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

Enrollment: 50 estimated patients

Sex: Male

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age (16 - 45 years)
• Any grade of gynecomastia well be included

Exclusion criteria

• 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. 6. Patients with history of cardiac disease or thromboembolic events.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Tumescent solution only (Control group)

Active Comparator group

Description:

"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.

Treatment:

Drug: Tranexamic acid injection

Tumescent solution with tranexamic acid added

Active Comparator group

Description:

"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.

Treatment:

Drug: Tranexamic acid injection

Tumescent solution with intravenous tranexamic acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid injection