About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Pregnant patients
Known allergy to CO2 Lift or Vaseline
History of keloid formation or significant dermatological conditions.
Coagulopathy or current use of anticoagulant therapy.
Trial design
Crossover
Treatments tested in this trial
Carboxytherapy
DrugApplication of the intervention (CO2 Lift) in the area according to the protocol schedule
Placebo
Other interventionApplication of the placebo (Vaseline) in the area according to the protocol schedule
Treatment groups
Trial outcomes
Primary outcomes
Ecchymosis of the area - 7 days post procedure
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).
Secondary outcomes
Ecchymosis of the area - 24 hours post procedure
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).
Ecchymosis of the area - 3 days post procedure
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).
Pain Score
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.
Patient Satisfaction Scores
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.
Sponsors and contacts
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