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

Total Definer Research Group

Status and phase: Completed; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06648265

ArmsTXA001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 78 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

TXA Group

Experimental group

Description:

Tumescent solution with TXA

Treatment:

Drug: Tumescent solution with dilute lidocaine and epinephrine

Drug: Tranexamic Acid (Topical)

Control Group

Placebo Comparator group

Description:

Tumescent Solution without TXA

Treatment:

Drug: Tumescent solution with dilute lidocaine and epinephrine