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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:
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:
Study Design: Randomized, controlled, single-blind trial
Study Locations:
Data Collection:
Ethical Considerations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 Lift group | Experimental |
|
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxytherapy | Drug | Application of the intervention (CO2 Lift) in the area according to the protocol schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Ecchymosis of the area - 3 days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alfredo Hoyos, MD | Contact | +13059154274 | alhoyos@gmail.com | |
| Mauricio Perez, MD | Contact | meperezmd@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Recruiting | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32091181 | Background | 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. | |
| 36641310 | 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. |
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Depending upon reasonable request
Immediately after publication.
Request to the main author
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Each patient serves as their own control, with one area receiving the intervention (CO2 Lift) and the contralateral area receiving placebo (Vaseline)
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| Placebo | Other | Application of the placebo (Vaseline) in the area according to the protocol schedule |
|
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). |
| 3 days |
| 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. | 7 days |
| 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. | 6 months |
| Dhara clinic | Recruiting | Bogotá | DC | Colombia |
|
| Private Practice | Recruiting | Mexico City | Mexico City | Mexico |
|
| 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 |
| ID | Term |
|---|---|
| D003288 | Contusions |
| D007249 | Inflammation |
| D010149 | Pain, Postoperative |
| D004438 | Ecchymosis |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D012877 | Skin Manifestations |
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