EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES

NCT06648265 | Completed Phase 4

• 1 other identifier: ArmsTXA001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Liposuction; Bruising; Inflammation; Skin Condition; Edema Arm; Ecchymosis; Hematoma

Keywords

Tranexamic Acid; Body contouring; Liposuction; Liposculpture; Patient outcomes; High Definition Liposculpture

Outcome Measures

Primary Outcomes (1)

• Ecchymosis of the arms

  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 Outcomes (2)

• Inflammation of the arm

  one week

• Satisfaction

  6 months

Study Arms (2)

TXA Group

EXPERIMENTAL

Tumescent solution with TXA

Drug: Tranexamic Acid (Topical); Drug: Tumescent solution with dilute lidocaine and epinephrine

Control Group

PLACEBO COMPARATOR

Tumescent Solution without TXA

Drug: Tumescent solution with dilute lidocaine and epinephrine

Interventions

Tranexamic Acid (Topical) DRUG

Add 250 mg of TXA per liter of Klein\'s Tumescent solution for arm liposculpture

TXA Group

Tumescent solution with dilute lidocaine and epinephrine DRUG

Arm infiltration with traditional Klein\'s tumescent solution

Control Group; TXA Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Total Definer Research Group: lead

Study Sites (1)

Clinica Dhara

Bogotá, Bogota D.C., 111111, Colombia

Location

Related Publications (4)

• Wolf Y, Skorochod R, Kwartin S, Shapira L. Tranexamic Acid Irrigation in Liposuction: A Double-Blind, Half-Body, Randomized, Placebo-Controlled Trial. Aesthetic Plast Surg. 2023 Dec;47(6):2525-2532. doi: 10.1007/s00266-023-03499-5. Epub 2023 Jul 24.

  PMID: 37488309 BACKGROUND

• Reinhardt ME, Mutyala S, Gerald M, Zhao H, Nova V, Araya Cambronero S, Patel S, Baltodano PA. The Critical Blood-Sparing Effect of Tranexamic Acid (TXA) in Liposuction: A Systematic Review and Meta-Analysis. JPRAS Open. 2023 Feb 2;40:48-58. doi: 10.1016/j.jpra.2023.01.002. eCollection 2024 Jun.

  PMID: 38425698 BACKGROUND

• Bayter-Marin JE, Hoyos A, Cardenas-Camarena L, Pena-Pinzon W, Bayter-Torres AF, Diaz-Diaz CA, McCormick-Mendez M, Plata-Rueda EL, Nino-Carreno CS. Effectiveness of Tranexamic Acid in the Postoperative Period in Body Contour Surgery: Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2023 Nov 15;11(11):e5403. doi: 10.1097/GOX.0000000000005403. eCollection 2023 Nov.

  PMID: 38025645 BACKGROUND

• Hoyos AE, Duran H, Cardenas-Camarena L, Bayter JE, Cala L, Perez M, Lopez A, Talleri G, Dominguez-Millan R, Mogollon IR. Use of Tranexamic Acid in Liposculpture: A Double-Blind, Multicenter, Randomized Clinical Trial. Plast Reconstr Surg. 2022 Sep 1;150(3):569-577. doi: 10.1097/PRS.0000000000009434. Epub 2022 Jun 28.

  PMID: 35759637 BACKGROUND

MeSH Terms

Conditions

Contusions; Inflammation; Skin Diseases; Ecchymosis; Hematoma

Interventions

Tranexamic Acid; Epinephrine

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mauricio E Perez Pachon, MD

  Department of Plastic Surgery | Scientific Division | Total Definer

  STUDY DIRECTOR

• Alfredo E Hoyos, MD

  Department of Plastic Surgery | Total Definer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: Crossover assignment (each subject serves as their own control with one arm receiving TXA and the other not)

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 18, 2024
• Study Start: January 20, 2022
• Primary Completion: February 15, 2024
• Study Completion: June 13, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CO (1)