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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTotal Definer Research Group

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Carboxytherapy

    Drug

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

  • Placebo

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CO2 Lift groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
7 days

Secondary outcomes

1

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).

Time frame
24 hours
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).

Time frame
3 days
3

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.

Time frame
7 days
4

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

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