LiposuctionPhase 4CO2L001NCT06791577
Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction
A Phase 4 study testing Carboxytherapy in people with Liposuction and Bruising, run by Total Definer Research Group at 3 sites in 3 countries.
Trial summary
The goal of this clinical trial is to evaluate if CO2 Lift reduces bruising and pain after Liposuction. The study also aims to explore changes in patient satisfaction. The main questions this study seeks to answer are: Does CO2 lift reduce the extent of bruising at 7 days post-surgery? How does CO2 lift impact… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liposuction, Bruising, Inflammation
- What is being tested?
- Carboxytherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Sep 2023to 15 Dec 2025
- Phase
- Phase 4
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermo-lipectomy.
- healthy patients without underlying comorbidities (classified as ASA≤II)
Who cannot join
- Pregnant patients
- Known allergy to CO2 Lift or Vaseline
- History of keloid formation or significant dermatological conditions.
- Coagulopathy or current use of anticoagulant therapy.
- Skin disorders related to collagen disease.
- BMI ≥ 32 kg/m2.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The goal of this clinical trial is to evaluate if CO2 Lift reduces bruising and pain after Liposuction. The study also aims to explore changes in patient satisfaction. The main questions this study seeks to answer are:
- Does CO2 lift reduce the extent of bruising at 7 days post-surgery?
- How does CO2 lift impact patient-reported pain and satisfaction?
Read more
In this study, researchers will compare CO2 lift to a placebo (Vaseline) to see if the intervention has a positive effect.
The study procedures include:
- Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, pain scores, and satisfaction scores.
- During the liposuction procedure the patient will receive CO2 Lift application to one arm, and/or one glute, and/or one half of the lower abdomen, and placebo (Vaseline) to the contralateral part.
- Apply CO2 lift and Vaseline immediately after surgery, 12 hours later, and then once a day for 3 to 5 days depending of the risk of the flap/skin.
- Postoperative follow-up with photos of treated areas at 24 hours, 3 days, and 7 days, with bruising quantified using Image J software.
Read the detailed description
Study Design: Randomized, controlled, single-blind trial
- Allocation: Randomized (one area with CO2 lift treatment, one area with Vaseline control)
- Intervention Model: Comparative contralateral randomized clinical trial (each participant serves as their own control, with CO2 lift applied to one area and Vaseline to the contralateral area).
- Masking: Single-blind (Participants are blinded to the treatment allocation).
Study Locations:
- Dhara Clinic, Bogota, Colombia
- Private Practice, Sao Paulo, Brazil
- Private Practice, Mexico City, Mexico
Data Collection:
- Photographic analysis with ImageJ, from photo records from days 1, 3, 7 post procedure, to calculate the percentage of the area with ecchymosis.
- Pain Assessment: Visual Analogue Scale (VAS) scores recorded at the same time points.
- Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively.
Ethical Considerations:
- Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained.
- IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB).
- Data Confidentiality: All participant data will be anonymized and securely stored.
- Conditions
- Liposuction, Bruising, Inflammation, Pain, Postoperative, Ecchymosis, Hematoma
- Being tested
- Carboxytherapy, Placebo
- Keywords
- Carboxytherapy, CO2 Lift, Body contouring, Liposuction, Liposculpture, High Definition Liposculpture, Patient outcomes
- Medical subject headings
- Contusions, Inflammation, Pain, Postoperative, Ecchymosis, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboxytherapyDrug
Application of the intervention (CO2 Lift) in the area according to the protocol schedule
PlaceboOther
Application of the placebo (Vaseline) in the area according to the protocol schedule
| Study group | Role | What they receive |
|---|---|---|
| CO2 Lift group | Experimental | * Application of CO2 lift to one arm, and/or one glute, and/or one half of the lower abdomen.
* Apply immediately after surgery and 12 hours later. Then one time per day for 3-5 days for patients with low risk for flap/skin ischemia/suffering. Receives: Drug: Carboxytherapy |
| Control group | Placebo comparator | * Application of Vaseline to the contralateral area in which CO2 lift was applied, using the same timing protocol as per CO2 lift Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecchymosis of the area - 7 days post procedure
Reduction of ecchymosis in each area, measured using Photomicrographic analysis with ImageJ Software. The unit of measurement will me in cm^2 of the affected area (bruised) normalized to the total area of the area (in cm^2).
Measured: 7 days
Secondary outcomes (4)
Ecchymosis of the area - 24 hours post procedure
Reduction of ecchymosis in each area, measured using Photomicrographic analysis with ImageJ Software. The unit of measurement will me in cm^2 of the affected area (bruised) normalized to the total area of the area (in cm^2).
Measured: 24 hours
Ecchymosis of the area - 3 days post procedure
Reduction of ecchymosis in each area, measured using Photomicrographic analysis with ImageJ Software. The unit of measurement will me in cm^2 of the affected area (bruised) normalized to the total area of the area (in cm^2).
Measured: 3 days
Pain Score
Patient-reported pain measured using Pain Visual Analogue Scale (VAS), measured at 24 hours, 3 days, and 7 days post-procedure. In the VAS pain scores, 0 represents no pain, while 10 represents the worst possible pain experienced.
Measured: 7 days
Patient Satisfaction Scores
Patient reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS).
The 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.
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 posted24 Jan 2025
- Study start1 Sep 2023
- Primary completion30 Jun 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Each patient serves as their own control, with one area receiving the intervention (CO2 Lift) and the contralateral area receiving placebo (Vaseline)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791577
- Sponsor's protocol ID
- Carboxy-gel (CO2 Lift)
- Acronym
- CO2L001
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depending upon reasonable request
Publications
Oliveira SMD, Rocha LB, da Cunha MTR, Cintra MMM, Pinheiro NM, Mendonca AC. Effects of carboxytherapy on skin laxity. J Cosmet Dermatol. 2020 Nov;19(11):3007-3013. doi: 10.1111/jocd.13337. Epub 2020 Feb 24.
PubMed 32091181Delgado-Miguel C, Miguel-Ferrero M. Preliminary results of the use of carboxytherapy in the treatment of pathologic scars: A minimally invasive alternative. J Pediatr Surg. 2023 Apr;58(4):679-683. doi: 10.1016/j.jpedsurg.2022.12.008. Epub 2022 Dec 22.
PubMed 36641310Waked K, Kierdaj M, Aslani A. The Use of Carboxytherapy for the Treatment of Deep Partial-Thickness Skin Burns After Circumferential and High-Definition Liposuction: Promising Clinical Results in 5 Consecutive Cases. Aesthetic Surg J Open Forum. 2023;5:ojad096. doi:10.1093/asjof/ojad096