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

Total Definer Research Group

Status and phase: Enrolling; Phase 4

Conditions: Ecchymosis; Bruising; Liposuction; Inflammation; Pain, Postoperative; Hematoma

Treatments: Other: Placebo; Drug: Carboxytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06791577

Carboxy-gel (CO2 Lift)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

CO2 Lift group

Experimental group

Description:

* 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.

Treatment:

Drug: Carboxytherapy

Control group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo