ClinicalTrials.gg
CompletedNCT06791577CO2L001Updated Jul 21, 2026

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 interventional study of Carboxytherapy and Placebo in Liposuction, Bruising and Inflammation, sponsored by Total Definer Research Group. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Total Definer Research Group · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 patient-reported pain and satisfaction?

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.
02

Conditions studied

  • Liposuction
  • Bruising
  • Inflammation
  • Pain, Postoperative
  • Ecchymosis
  • Hematoma

Keywords

  • Carboxytherapy
  • CO2 Lift
  • Body contouring
  • Liposuction
  • Liposculpture
  • High Definition Liposculpture
  • Patient outcomes
03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's enrollment of 72 is below the median of 90 across 31 interventional studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
  • ≥ 32 kg/m2.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    CO2 Lift group

    * 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.

    Drug: Carboxytherapy

  • Placebo comparator
    Control group

    \* Application of Vaseline to the contralateral area in which CO2 lift was applied, using the same timing protocol as per CO2 lift

    Other: Placebo

Interventions

  • DrugCarboxytherapy

    Application of the intervention (CO2 Lift) in the area according to the protocol schedule

  • OtherPlacebo

    Application of the placebo (Vaseline) in the area according to the protocol schedule

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 7 days

Secondary outcomes

  1. 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).

    Time frame: 24 hours

  2. 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).

    Time frame: 3 days

  3. 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.

    Time frame: 7 days

  4. 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.

    Time frame: 6 months

07

Study locations

3 sites
  • Private Practice
    São Paulo, Brazil
  • Dhara clinic
    Bogotá, DC, Colombia
  • Private Practice
    Mexico City, Mexico City, Mexico
08

References and documents

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 32091181 ↗
  • Delgado-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 36641310 ↗
  • Waked 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

Individual participant data

Plan to share: Yes — Depending upon reasonable request

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Immediately after publication.

Access criteria: Request to the main author

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Jun 2025, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2025
First posted
Jan 24, 2025
StartActual
Sep 1, 2023
Primary completionActual
Jun 30, 2025
CompletionActual
Dec 15, 2025
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06791577
Lead sponsor
Total Definer Research Group
Responsible party
Alfredo Hoyos (Plastic Surgeon, Total Definer Research Group) — Principal investigator
First posted
Jan 24, 2025
Start date
Sep 1, 2023
Primary completion
Jun 30, 2025
Completion
Dec 15, 2025
Last update
Jul 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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