RecruitingPhase 4NCT06791577

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


Sponsor

Total Definer Research Group

Enrollment

50 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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.

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Interventions

DRUGCarboxytherapy

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

OTHERPlacebo

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


Locations(3)

Private Practice

São Paulo, Brazil

Dhara clinic

Bogotá, DC, Colombia

Private Practice

Mexico City, Mexico City, Mexico

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NCT06791577


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