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

Different Methods of Tranexamic Acid Application in Controlling Perio Operative Bleeding in Gynecomastia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pharmacological-Aggravated Urticaria
• Intervention / Treatment: Drug: Tranexamic acid injection

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: amjad ahmed al-gubari, bchelor ged; Phone Number: 0882315377 01080769394; Email: amjadgubari@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Tranexamic acid injection; work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery
Active Comparator: 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.	Drug: Tranexamic acid injection; work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery
Active Comparator: 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.	Drug: Tranexamic acid injection; work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss during liposuction in milliliters	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.	"Intraoperatively" Unit of Measure: Milliliters (mL)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgical drain placement in days	The number of days the surgical drain remains in place post-operatively, until drainage is less than 30 mL per 24 hours. This will be reported as mean number of days with standard deviation for each study group.	From immediate post-operation until drain removal (expected within 3 to 7 days)" Unit of Measure: Days
Change in hemoglobin concentration from baseline to 24 hours post-operation	The difference in hemoglobin concentration between preoperative baseline and 24 hours post-operation. This will be reported as mean change in g/dL with standard deviation for each study group.	Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Grams per deciliter (g/dL)
Extent of post-operative ecchymosis at 7 days	The extent of ecchymosis will be assessed using a standardized photographic scale, ranging from 0 (no ecchymosis) to 4 (severe ecchymosis). This will be reported as median score with interquartile range for each study group."	"7 days post-operation" Unit of Measure: Ordinal scale score (0-4)
Changes in coagulation profile at 24 hours post-operation	Changes in prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) from baseline to 24 hours post-operation. These will be reported as mean changes with standard deviations for each parameter in each study group.	"Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Seconds for PT and aPTT, no units for INR

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2024
• Primary Completion (Estimated): July 20, 2024
• Study Completion (Estimated): April 20, 2025

Study Registration Dates

• First Submitted: June 8, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Breast Diseases; Skin Diseases, Vascular; Hypersensitivity; Gynecomastia; Urticaria; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: plastic surgery department

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No