NCT06791577

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Total Definer Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Carboxytherapy	Application of the intervention (CO2 Lift) in the area according to the protocol schedule
OTHER	Placebo	Application of the placebo (Vaseline) in the area according to the protocol schedule

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-06-30
• Completion: 2025-12-15
• First posted: 2025-01-24
• Last updated: 2025-04-30

Locations

3 sites across 3 countries: Brazil, Colombia, Mexico