EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES

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).

• Tranexamic Acid (Topical) (Drug): Add 250 mg of TXA per liter of Klein\'s Tumescent solution for arm liposculpture
• Tumescent solution with dilute lidocaine and epinephrine (Drug): Arm infiltration with traditional Klein\'s tumescent solution

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to 60 Years, 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.

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