EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES (ARMTXA)

April 27, 2025 updated by: Alfredo Hoyos, Total Definer Research Group

IMPACT OF TRANEXAMIC ACID IN TUMESCENT SOLUTION ON POSTOPERATIVE OUTCOMES AFTER LIPOSUCTION: A DOUBLE-BLIND, CONTRALATERAL ARM RANDOMIZED CLINICAL TRIAL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia, 111111
        • Clinica Dhara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TXA Group
Tumescent solution with TXA
Drug: Tranexamic Acid (Topical)
Add 250 mg of TXA per liter of Klein's Tumescent solution for arm liposculpture
Drug: Tumescent solution with dilute lidocaine and epinephrine
Arm infiltration with traditional Klein's tumescent solution
Placebo Comparator: Control Group
Tumescent Solution without TXA
Drug: Tumescent solution with dilute lidocaine and epinephrine
Arm infiltration with traditional Klein's tumescent solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ecchymosis of the arms
Time Frame: 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.
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation of the arm
Time Frame: 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.
one week
Satisfaction
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Total Definer Research Group

Investigators

  • Study Director: Mauricio E Perez Pachon, MD, Department of Plastic Surgery | Scientific Division | Total Definer
  • Principal Investigator: Alfredo E Hoyos, MD, Department of Plastic Surgery | Total Definer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

June 13, 2024

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArmsTXA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Our data contains information about highly influential people who are not willing to publicly share their data.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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