A Phase 4 interventional study of Tranexamic Acid (Topical) and Tumescent solution with dilute lidocaine and epinephrine in Liposuction, Bruising and Inflammation, sponsored by Total Definer Research Group. Completed at 1 site in Colombia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Total Definer Research Group · Phase 4, Interventional, and Prevention
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:
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.
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).
43 studies on the registry are indexed under Contusions; 8 are open to participants now.
This study's enrollment of 78 is below the median of 90 across 31 interventional studies indexed under Contusions.
Browse Contusions studies →Total Definer Research Group is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tumescent solution with TXA
Drug: Tranexamic Acid (Topical) · Drug: Tumescent solution with dilute lidocaine and epinephrine
Tumescent Solution without TXA
Drug: Tumescent solution with dilute lidocaine and epinephrine
Add 250 mg of TXA per liter of Klein\'s Tumescent solution for arm liposculpture
Arm infiltration with traditional Klein\'s tumescent solution
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.
Time frame: One week
Inflammation of the arm
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.
Time frame: one week
Satisfaction
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.
Time frame: 6 months
Plan to share: Undecided — Our data contains information about highly influential people who are not willing to publicly share their data.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tranexamic Acid
Total Definer Research Group