EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES

Phase 4

Completed

• Conditions: Liposuction; Bruising; Inflammation; Skin Condition; Edema Arm; Ecchymosis; Hematoma
• Interventions: Drug: Tranexamic Acid (Topical); Drug: Tumescent solution with dilute lidocaine and epinephrine

• Registration Number: NCT06648265
• Lead Sponsor: Total Definer Research Group

Brief Summary

The goal of this trial is to evaluate the effect of adding Tranexamic Acid (TXA) to the tumescent solution used in arm liposuction on postoperative outcomes. Study population includes healthy volunteer adults undergoing Liposculpture procedures. The main question it aims to answer is:

1. Does Tranexamic acid exert benefit on postoperative outcomes after liposuction? Researchers will compare TXA versus traditional tumescent solution to see if there are benefits on adding it to the tumescent solution.

Participants will undergo High Definition Liposculpture involving arms, legs and their torso. One arm will be infiltrated with traditional Klein's tumescent solution and the other one with the same one but adding Tranexamic Acid.

Detailed Description

Study Design:

Allocation: Randomized (one arm with TXA, one without) Intervention Model: Crossover assignment (each subject serves as their own control with one arm receiving TXA and the other not) Masking: Double-blind (Participant and Outcomes Assessor)

Interventions:

Experimental Arm (TXA): Infiltration with Klein's tumescent solution (1000 ml of Ringer's Lactate + Epinephrine 1 mg + Lidocaine 1 mg) plus 250 mg of tranexamic acid.

Control Arm: Infiltration with Klein's tumescent solution (1000 ml of Ringer's Lactate + Epinephrine 1 mg + Lidocaine 1 mg) without tranexamic acid.

Recruitment Information:

Adults aged 18-60 undergoing elective High Definition liposuction. No known allergies to TXA or lidocaine. BMI of 30 kg/m\^2.

Study Start Date: January 2022. Primary Completion Date: January 2024. Study Completion Date: June 2024. Study Locations: Clinica Dhara, Bogota DC, Colombia.

Data Collection: Photomicrographic analysis with ImageJ (Fiji): Photos taken on days 1, 3, and 7 will be processed to calculate the surface area of ecchymosis.

Manual arm circumference measurements: Measurements will be taken with a tape measure to monitor local swelling/inflammation.

Ethical Considerations:

Informed Consent: Participants will be provided with detailed information about the study and will be required to provide informed consent prior to participation.

IRB Approval: The trial will be conducted in compliance with ethical standards and will be reviewed and approved by an Institutional Review Board (IRB).

Study Timeline

• Study Start: 2022-01-20
• Primary Completion: 2024-02-15
• Study Completion: 2024-06-13
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Adults aged 18-60 undergoing elective arm liposuction.
• No known allergies to TXA or lidocaine.
• BMI < 30.

Exclusion Criteria

• Previous surgery or trauma to the arms.
• Known coagulation disorders.
• History of thromboembolic events.
• ASA > II.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TXA Group	Tranexamic Acid (Topical)	Tumescent solution with TXA
TXA Group	Tumescent solution with dilute lidocaine and epinephrine	Tumescent solution with TXA
Control Group	Tumescent solution with dilute lidocaine and epinephrine	Tumescent Solution without TXA

Primary Outcome Measures

Name	Time	Method
Ecchymosis of the arms	One week	NAME OF THE MEASUREMENT: Area of ecchymosis of each arm MEASUREMENT TOOL: Photomicrographic analysis with ImageJ (Fiji) Software. UNIT OF MEASURE: Area (in cm\^2) affected by bruising normalized to the total area of the arm (in cm\^2).; Timing: Repeated measures in a standard position and lighting conditions after liposuction on days 1, 3 and 7 postoperatively.

Secondary Outcome Measures

Name	Time	Method
Inflammation of the arm	one week	NAME OF THE MEASUREMENT: Inflammation of the arms MEASUREMENT TOOL: Metric tape to assess the circumference of the arm. UNIT OF MEASURE: Circumference (in cm) measured at the midpoint of the arm. Timing: Repeated measures in a standard position (90 degree elbow flexion and 90 degree shoulder abduction) after liposuction on days 1, 3 and 7 postoperatively.
Satisfaction	6 months	NAME OF THE MEASUREMENT: Aesthetic assessment after liposuction.; MEASUREMENT TOOL: Global Aesthetic Improvement Scale (GAIS), is a standardized scale used primarily in cosmetic and dermatological treatments to assess the overall aesthetic improvement of a patient after a procedure. It consist of three questions: * how do you feel about your appearance after surgery? Possible answers: Very much improved, much improved, slightly improved, no change.; * Are you satisfied with the surgery? Very satisfied, satisfied, not satisfied.; * Would you recommend the surgical procedure? Possible answers: Yes, perhaps, no.; UNIT OF MEASURE: Rate of satisfaction, appearance and recommendation of the procedure.; Timing: Six months after surgery.

Trial Locations

Locations (1)

Clinica Dhara; 🇨🇴 Bogota, Colombia