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

NCT ID: NCT06509256

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2025-04-20

Brief Summary

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

Detailed 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

Conditions

Pharmacological-Aggravated Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery

Interventions

Tranexamic acid injection

work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amjad Ahmed Qasim AL-Gubari

Resident of Plastic Surgery, Department of Plastic and Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

amjad ahmed al-gubari, bchelor ged

Role: CONTACT

amjadgubari@gmail.com

01080769394 ext. 0882315377

Other Identifiers

plastic surgery department

Identifier Type: -

Identifier Source: org_study_id