Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction (CO2L001)

April 27, 2025 updated by: Alfredo Hoyos, Total Definer Research Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Private Practice
        • Contact:
  • Colombia
    • DC
      • Bogota, DC, Colombia
        • Recruiting
        • Dhara Clinic
        • Contact:
        • Principal Investigator:
          • Alfredo E Hoyos, MD
  • Mexico
    • DF
      • Mexico City, DF, Mexico
        • Recruiting
        • Private Practice
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Application of the intervention (CO2 Lift) in the area according to the protocol schedule
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
Application of the placebo (Vaseline) in the area according to the protocol schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 hours
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 days
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.
7 days
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Total Definer Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carboxy-gel (CO2 Lift)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Depending upon reasonable request

IPD Sharing Time Frame

Immediately after publication.

IPD Sharing Access Criteria

Request to the main author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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