Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06791577

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

Led by Total Definer Research Group · Updated on 2025-04-30

50

Participants Needed

3

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of CO2 Lift to reduce bruising and pain after liposuction in this randomized, controlled, single-blind clinical trial. The study aims to determine if CO2 Lift lessens bruising at 7 days post-surgery and how it affects patient-reported pain and satisfaction. The trial compares CO2 Lift with a placebo (Vaseline) applied to different body areas during liposuction procedures. Participants receive CO2 Lift applied to one arm, one glute, or one half of the lower abdomen, while the contralateral area receives Vaseline as a control. The applications occur immediately after surgery, 12 hours later, and then once daily for 3 to 5 days depending on skin risk. This comparative contralateral design allows each participant to serve as their own control. During the study, researchers will collect baseline sociodemographic and surgical data, pain scores using a Visual Analogue Scale, and patient satisfaction scores with the Global Aesthetic Improvement Scale at least 3 months postoperatively. Postoperative follow-up includes photographic assessments of bruising at 24 hours, 3 days, and 7 days using ImageJ software. Safety and adverse events will also be monitored throughout the trial, which runs until December 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing body contouring procedures such as liposuction or liposculpture, alone or combined with up to two other major aesthetic procedures involving face, breast, or dermo-lipectomy
  • Healthy patients without underlying comorbidities classified as ASA II or lower
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • 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
  • Body mass index (BMI) of 32 kg/m2 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 5 days post-surgery

Participants receive either CO2 lift treatment or Vaseline placebo applied to different areas immediately after surgery, then 12 hours later, followed by once daily applications for 3 to 5 days depending on risk factors.

1 baseline visit and daily visits for up to 5 days

Follow-up

Duration - 6 months

Participants are assessed for bruising and pain at days 1, 3, and 7 post-procedure and provide satisfaction scores at 6 months postoperatively.

3 visits in the first week post-procedure and 1 visit at 6 months

Trial Site Locations

Total: 3 locations

1

Private Practice

São Paulo, Brazil

Actively Recruiting

2

Dhara clinic

Bogotá, DC, Colombia

Actively Recruiting

3

Private Practice

Mexico City, Mexico City, Mexico

Actively Recruiting

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Research Team

A

Alfredo Hoyos, MD

M

Mauricio Perez, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Preliminary results of the use of carboxytherapy in the treatment of pathologic scars: A minimally invasive alternative.

Carlos Delgado-Miguel, Miriam Miguel-Ferrero

https://pubmed.ncbi.nlm.nih.gov/36641310