IMPACT OF TRANEXAMIC ACID IN TUMESCENT SOLUTION ON POSTOPERATIVE OUTCOMES AFTER LIPOSUCTION: A DOUBLE-BLIND, CONTRALATERAL ARM RANDOMIZED CLINICAL TRIAL
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Ecchymosis of the arms
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
TXA Group
Tumescent solution with TXA
Intervention: Tranexamic Acid (Topical) (Drug)
TXA Group
Tumescent solution with TXA
Intervention: Tumescent solution with dilute lidocaine and epinephrine (Drug)
Control Group
Tumescent Solution without TXA
Intervention: Tumescent solution with dilute lidocaine and epinephrine (Drug)
Outcomes
Primary Outcomes
Ecchymosis of the arms
Time Frame: 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)
- Satisfaction(6 months)
Investigators
Alfredo Hoyos
Plastic Surgeon
Total Definer Research Group