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

Last updated: January 19, 2025
Sponsor: Total Definer Research Group
Overall Status: Active - Recruiting

Phase

4

Condition

Inflammation

Skin Wounds

Liposuction

Treatment

Carboxytherapy

Placebo

Clinical Study ID

NCT06791577
Carboxy-gel (CO2 Lift)
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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 participants in this clinical trial will have to be adults (between 18-65 years) scheduled for Liposuction, with or without any additional procedures. The participants can not be pregnant, have history of scaring/healing problems, severe dermatological conditions, be obese, or have important comorbidities.

The study procedures include:

  • Baseline data collection and photographic records.

  • 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.

  • Patient-reported pain is recorded using the Visual Analogue Scale (VAS), and satisfaction is assessed with the Global Aesthetic Improvement Scale (GAIS).

Primary Outcome:

  • Reduction in bruised area at 7 days post-surgery.

Secondary Outcomes:

  • Reduction in bruising at 24 hours and 3 days post-surgery.

  • Patient-reported pain and satisfaction scores.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing body contouring procedures (liposuction or liposculpture),either individually or combined with a maximum of two other major aestheticprocedures involving face, breast, or dermolipectomy.

  • ealthy patients without underlying comorbidities (classified as ASA≤II)

Exclusion

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.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Carboxytherapy
Phase: 4
Study Start date:
September 01, 2023
Estimated Completion Date:
December 15, 2025

Study 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).

Intervention:

  • Experimental area (CO2 Lift Treatment area): 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.

  • Control area (Control - Vaseline): Application of Vaseline to the contralateral area in which CO2 lift was applied. Use the same timing protocol as per CO2 lift.

Recruitment information/Selection criteria:

  • Inclusion: Adult patients (18-65 years), undergoing elective High Definition liposuction.

  • Exclusion: Known allergies to CO2 lift or Vaseline. Scaring, healing or dermatological conditions. Obese patients BMI≥ 32 kg/m2.

Timeline:

  • Study Start Date: August 2022.

  • Primary Completion Date: June 2025.

  • Study Completion Date: December 2025.

Study Locations:

  • Dhara Clinic, Bogota, Colombia

  • Private Practice, Sao Paulo, Brazil

  • Private Practice, Cuidad de Mexico, 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.

Connect with a study center

  • Private Practice

    Sao Paulo,
    Brazil

    Active - Recruiting

  • Dhara clinic

    Bogota, DC
    Colombia

    Active - Recruiting

  • Private Practice

    Cuidad de Mexico, DF
    Mexico

    Active - Recruiting

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