Total Definer Research Group
Alfredo Hoyos
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.
Liposuction
Bruising
Inflammation
Skin Condition
Edema Arm
Ecchymosis
Hematoma
Tranexamic Acid (Topical)
Tumescent solution with dilute lidocaine and epinephrine
PHASE4
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).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 78 participants |
| Masking : | TRIPLE |
| Primary Purpose : | PREVENTION |
| Official Title : | IMPACT of TRANEXAMIC ACID in TUMESCENT SOLUTION on POSTOPERATIVE OUTCOMES AFTER LIPOSUCTION: a DOUBLE-BLIND, CONTRALATERAL ARM RANDOMIZED CLINICAL TRIAL |
| Actual Study Start Date : | 2022-01-20 |
| Estimated Primary Completion Date : | 2024-02-15 |
| Estimated Study Completion Date : | 2024-06-13 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 60 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
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Not yet recruiting
Clinica
Bogota, Colombia, 111111