EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES

NCT ID: NCT06648265

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2024-06-13

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

TXA Group

Tumescent solution with TXA

Group Type: EXPERIMENTAL

Tranexamic Acid (Topical)

Intervention Type: DRUG

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

Tumescent solution with dilute lidocaine and epinephrine

Intervention Type: DRUG

Arm infiltration with traditional Klein\'s tumescent solution

Control Group

Tumescent Solution without TXA

Group Type: PLACEBO_COMPARATOR

Tumescent solution with dilute lidocaine and epinephrine

Intervention Type: DRUG

Arm infiltration with traditional Klein\'s tumescent solution

Interventions

Tranexamic Acid (Topical)

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

Intervention Type: DRUG

Tumescent solution with dilute lidocaine and epinephrine

Arm infiltration with traditional Klein\'s tumescent solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Total Definer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Hoyos

Plastic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauricio E Perez Pachon, MD

Role: STUDY_DIRECTOR

Department of Plastic Surgery | Scientific Division | Total Definer

Alfredo E Hoyos, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Plastic Surgery | Total Definer

Locations

Clinica Dhara

Bogotá, Bogota D.C., Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 37488309 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38425698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38025645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35759637 (View on PubMed)

Other Identifiers

ArmsTXA001

Identifier Type: -

Identifier Source: org_study_id