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Completed

NCT Number: NCT06791577

Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction

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.

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Key information

Conditions

Liposuction Blood Coagulation Disorders Bruising Contusions Ecchymosis Hematologic Diseases Hematoma Hemic and Lymphatic Diseases Hemorrhage Inflammation Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Manifestations Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Private Practice, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Carboxytherapy

Drug

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

Placebo

Other

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

Primary outcomes

  1. Ecchymosis of the area - 7 days post procedure

    Time frame: 7 days

    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).

Secondary outcomes

  1. Ecchymosis of the area - 24 hours post procedure

    Time frame: 24 hours

    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).

  2. Ecchymosis of the area - 3 days post procedure

    Time frame: 3 days

    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).

  3. Pain Score

    Time frame: 7 days

    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.

  4. Patient Satisfaction Scores

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Total Definer Research Group

Other

Registry information

Acronym: CO2L001

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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