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

NCT06791577 | Recruiting Phase 4

• 1 other identifier: Carboxy-gel (CO2 Lift)
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 3

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.

Conditions

Liposuction; Bruising; Inflammation; Pain, Postoperative; Ecchymosis; Hematoma

Keywords

Carboxytherapy; CO2 Lift; Body contouring; Liposuction; Liposculpture; High Definition Liposculpture; Patient outcomes

Outcome Measures

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).

  7 days

Secondary Outcomes (4)

• Ecchymosis of the area - 24 hours post procedure

  24 hours

• Ecchymosis of the area - 3 days post procedure

  3 days

• Pain Score

  7 days

• Patient Satisfaction Scores

  6 months

Study Arms (2)

CO2 Lift group

EXPERIMENTAL

* Application of CO2 lift to one arm, and/or one glute, and/or one half of the lower abdomen. * Apply immediately after surgery and 12 hours later. Then one time per day for 3-5 days for patients with low risk for flap/skin ischemia/suffering.

Drug: Carboxytherapy

Control group

PLACEBO COMPARATOR

\* Application of Vaseline to the contralateral area in which CO2 lift was applied, using the same timing protocol as per CO2 lift

Other: Placebo

Interventions

Carboxytherapy DRUG

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

CO2 Lift group

Placebo OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Total Definer Research Group: lead

Study Sites (3)

Private Practice

São Paulo, Brazil

RECRUITING

Dhara clinic

Bogotá, DC, Colombia

RECRUITING

Private Practice

Mexico City, Mexico City, Mexico

RECRUITING

Related Publications (3)

• 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.

  PMID: 32091181 BACKGROUND

• 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.

  PMID: 36641310 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Contusions; Inflammation; Pain, Postoperative; Ecchymosis; Hematoma

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Skin Manifestations

Central Study Contacts

Alfredo Hoyos, MD

CONTACT

+13059154274; alhoyos@gmail.com

Mauricio Perez, MD

CONTACT

meperezmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: Each patient serves as their own control, with one area receiving the intervention (CO2 Lift) and the contralateral area receiving placebo (Vaseline)

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: September 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 15, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Immediately after publication.
• Access Criteria: Request to the main author

Locations

ME (1); BR (1); CO (1)