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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Brazil
Private Practice
RECRUITING
São Paulo
Colombia
Dhara clinic
RECRUITING
Bogotá
Mexico
Private Practice
RECRUITING
Mexico City
Contact Information
Primary
Alfredo Hoyos, MD
alhoyos@gmail.com
+13059154274
Backup
Mauricio Perez, MD
meperezmd@gmail.com
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 50
Treatments
Experimental: CO2 Lift group
* 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.
Placebo_comparator: Control group
\* Application of Vaseline to the contralateral area in which CO2 lift was applied, using the same timing protocol as per CO2 lift
Related Therapeutic Areas
Sponsors
Leads: Total Definer Research Group

This content was sourced from clinicaltrials.gov