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

NCT06509256 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: plastic surgery department
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pharmacological-Aggravated Urticaria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

• 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)

• Extent of post-operative ecchymosis at 7 days

  "7 days post-operation" Unit of Measure: Ordinal scale score (0-4)

• 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

Study Arms (3)

Tumescent solution only (Control group)

ACTIVE COMPARATOR

"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

Tumescent solution with tranexamic acid added

ACTIVE COMPARATOR

"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

Tumescent solution with intravenous tranexamic acid

ACTIVE COMPARATOR

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

Interventions

Tranexamic acid injection DRUG

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

Tumescent solution only (Control group); Tumescent solution with intravenous tranexamic acid; Tumescent solution with tranexamic acid added

Eligibility Criteria

• Age: 16 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

amjad ahmed al-gubari, bchelor ged

CONTACT

01080769394; amjadgubari@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Plastic Surgery, Department of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: July 19, 2024
• Study Start: July 20, 2024
• Primary Completion: July 20, 2024
• Study Completion: April 20, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share