Liposuction, Bruising, Inflammation, Pain, Postoperative, Ecchymosis, Hematoma
Conditions
Keywords
Carboxytherapy, CO2 Lift, Body contouring, Liposuction, Liposculpture, High Definition Liposculpture, Patient outcomes
Brief 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.
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
Sponsors
Total Definer Research Group
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Each patient serves as their own control, with one area receiving the intervention (CO2 Lift) and the contralateral area receiving placebo (Vaseline)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ecchymosis of the area - 7 days post procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ecchymosis of the area - 24 hours post procedure | 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). |
| Ecchymosis of the area - 3 days post procedure | 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). |
| Pain Score | 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. |
| Patient Satisfaction Scores | 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. |
Countries
Brazil, Colombia, Mexico
Contacts
Primary ContactAlfredo Hoyos, MD
Backup ContactMauricio Perez, MD
Outcome results
None listed