Bruising, Ecchymosis, Edema Arm, Hematoma, Inflammation, Liposuction, Skin Condition
Conditions
Keywords
Tranexamic Acid, Body contouring, Liposuction, Liposculpture, Patient outcomes, High Definition Liposculpture
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).
Interventions
Add 250 mg of TXA per liter of Klein's Tumescent solution for arm liposculpture
Arm infiltration with traditional Klein's tumescent solution
Sponsors
Total Definer Research Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Crossover assignment (each subject serves as their own control with one arm receiving TXA and the other not)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Colombia
Outcome results
None listed