Clinical trial NCT06791577: Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction
Official title: Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liposuction
Bruising
Inflammation
Pain, Postoperative
Ecchymosis
Hematoma
Keywords: Carboxytherapy
CO2 Lift
Body contouring
Liposuction
Liposculpture
High Definition Liposculpture
Patient outcomes
Lead sponsor: Total Definer Research Group
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ecchymosis of the area - 7 days post procedure
timeFrame: 7 days
Secondary outcomes:
measure: Ecchymosis of the area - 24 hours post procedure
timeFrame: 24 hours
measure: Ecchymosis of the area - 3 days post procedure
timeFrame: 3 days
measure: Pain Score
timeFrame: 7 days
measure: Patient Satisfaction Scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Private Practice
city: Bogota
country: Colombia
facility: Dhara clinic
state: DC
city: Mexico City
country: Mexico
facility: Private Practice
state: DF
Study officials:
References:
citation: Oliveira SMD, Rocha LB, da Cunha MTR, Cintra MMM, Pinheiro NM, Mendonca AC. Effects of carboxytherapy on skin laxity. J Cosmet Dermatol. 2020 Nov;19(11):3007-3013. doi: 10.1111/jocd.13337. Epub 2020 Feb 24.
citation: Delgado-Miguel C, Miguel-Ferrero M. Preliminary results of the use of carboxytherapy in the treatment of pathologic scars: A minimally invasive alternative. J Pediatr Surg. 2023 Apr;58(4):679-683. doi: 10.1016/j.jpedsurg.2022.12.008. Epub 2022 Dec 22.
citation: Waked K, Kierdaj M, Aslani A. The Use of Carboxytherapy for the Treatment of Deep Partial-Thickness Skin Burns After Circumferential and High-Definition Liposuction: Promising Clinical Results in 5 Consecutive Cases. Aesthetic Surg J Open Forum. 2023;5:ojad096. doi:10.1093/asjof/ojad096