LiposuctionPhase 4ARMTXANCT06648265
EFFECTS OF TRANEXAMIC ACID IN TUMESCENT SOLUTION FOR LIPOSUCTION PROCEDURES
A Phase 4 study testing Tranexamic Acid (Topical) and Tumescent solution with dilute lidocaine and epinephrine in people with Liposuction and Bruising, run by Total Definer Research Group at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liposuction, Bruising, Inflammation
- What is being tested?
- Tranexamic Acid (Topical) and Tumescent solution with dilute lidocaine and epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteColombia
- Study dates
- 20 Jan 2022to 13 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-60 undergoing elective arm liposuction.
- No known allergies to TXA or lidocaine.
- BMI \< 30.
Who cannot join
- Previous surgery or trauma to the arms.
- Known coagulation disorders.
- History of thromboembolic events.
- ASA \> II.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT OF TRANEXAMIC ACID IN TUMESCENT SOLUTION ON POSTOPERATIVE OUTCOMES AFTER LIPOSUCTION: A DOUBLE-BLIND, CONTRALATERAL ARM RANDOMIZED CLINICAL TRIAL
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.
Read the 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).
- Conditions
- Liposuction, Bruising, Inflammation, Skin Condition, Edema Arm, Ecchymosis
- Being tested
- Tranexamic Acid (Topical), Tumescent solution with dilute lidocaine and epinephrine
- Keywords
- Tranexamic Acid, Body contouring, Liposuction, Liposculpture, Patient outcomes, High Definition Liposculpture
- Medical subject headings
- Contusions, Inflammation, Skin Diseases, Ecchymosis, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 epinephrineDrug
Arm infiltration with traditional Klein\'s tumescent solution
| Study group | Role | What they receive |
|---|---|---|
| TXA Group | Experimental | Tumescent solution with TXA Receives: Drug: Tranexamic Acid (Topical); Drug: Tumescent solution with dilute lidocaine and epinephrine |
| Control Group | Placebo comparator | Tumescent Solution without TXA Receives: Drug: Tumescent solution with dilute lidocaine and epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start20 Jan 2022
- Primary completion15 Feb 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LiposuctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover assignment (each subject serves as their own control with one arm receiving TXA and the other not)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Total Definer Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Hoyos, Total Definer Research Group
- Investigators
- Mauricio E Perez Pachon, MD, Study director, Department of Plastic Surgery | Scientific Division | Total DefinerAlfredo E Hoyos, MD, Principal investigator, Department of Plastic Surgery | Total Definer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648265
- Sponsor's protocol ID
- ArmsTXA001
- Acronym
- ARMTXA
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our data contains information about highly influential people who are not willing to publicly share their data.
Publications
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.
PubMed 37488309Reinhardt 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.
PubMed 38425698Bayter-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.
PubMed 38025645Hoyos AE, Duran H, Cardenas-Camarena L, Bayter JE, Cala L, Perez M, Lopez A, Talleri G, Dominguez-Millan R, Mogollon IR. Use of Tranexamic Acid in Liposculpture: A Double-Blind, Multicenter, Randomized Clinical Trial. Plast Reconstr Surg. 2022 Sep 1;150(3):569-577. doi: 10.1097/PRS.0000000000009434. Epub 2022 Jun 28.
PubMed 35759637
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF TRANEXAMIC ACID IN TUMESCENT SOLUTION ON POSTOPERATIVE OUTCOMES AFTER LIPOSUCTION: A DOUBLE-BLIND, CONTRALATERAL ARM RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06648265
- Acronym / sponsor ID
- ARMTXA / ArmsTXA001
- Conditions
- Liposuction, Bruising, Inflammation, Skin Condition, Edema Arm, Ecchymosis
- Keywords
- Tranexamic Acid, Body contouring, Liposuction, Liposculpture, Patient outcomes, High Definition Liposculpture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Total Definer Research GroupUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover assignment (each subject serves as their own control with one arm receiving TXA and the other not)
| Arm | Type | Receives |
|---|---|---|
| TXA Group | Experimental | Drug: Tranexamic Acid (Topical), Drug: Tumescent solution with dilute lidocaine and epinephrineTumescent solution with TXA |
| Control Group | Placebo comparator | Drug: Tumescent solution with dilute lidocaine and epinephrineTumescent Solution without TXA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-60 undergoing elective arm liposuction.
- No known allergies to TXA or lidocaine.
- BMI \< 30.
Key exclusion criteria (4 listed)
- Previous surgery or trauma to the arms.
- Known coagulation disorders.
- History of thromboembolic events.
- ASA \> II.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (Topical)Add 250 mg of TXA per liter of Klein\'s Tumescent solution for arm liposculpture | Drug | TXA Group |
| Tumescent solution with dilute lidocaine and epinephrineArm infiltration with traditional Klein\'s tumescent solution | Drug | Control Group, TXA Group |
Primary outcome
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.
2 secondary outcomes
Inflammation of the arm
Time frame: one week
Satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 37488309Wolf 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.
- Background: PubMed 38425698Reinhardt 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.
- Background: PubMed 38025645Bayter-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.
- Background: PubMed 35759637Hoyos AE, Duran H, Cardenas-Camarena L, Bayter JE, Cala L, Perez M, Lopez A, Talleri G, Dominguez-Millan R, Mogollon IR. Use of Tranexamic Acid in Liposculpture: A Double-Blind, Multicenter, Randomized Clinical Trial. Plast Reconstr Surg. 2022 Sep 1;150(3):569-577. doi: 10.1097/PRS.0000000000009434. Epub 2022 Jun 28.
- Individual participant dataSharing planned: Undecided. Our data contains information about highly influential people who are not willing to publicly share their data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (Topical) and Tumescent solution with dilute lidocaine and epinephrine in people with Liposuction and Bruising, run by Total Definer Research Group at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ecchymosis of the arms (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06648265, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.