Body Contouring Surgery, Liposuction, Skin Elasticity, Skin Firmness, Skin Laxity, Skin Tightening
Conditions
Keywords
Quantum, Quantum RF, Elastometer, Body contouring, Liposuction, Liposculpture, High Definition Liposculpture
Brief summary
This prospective study aims to evaluate the safety and effectiveness of Quantum, a fully internal bipolar radiofrequency probe, for the treatment of prominent skin laxity, providing patients with a more toned and youthful appearance, in patients undergoing High-Definition (HD) Liposculpture. The main questions this study seeks to answer are: * Does Quantum reduce skin laxity in patients undergoing HD Liposculpture? * Is the effectiveness in skin laxity reduction influenced by demographical factors, including age, gender, and phototype? The participants will be adult patients (between 18-60 years) undergoing HD Liposculpture, with any measurable degree of skin laxity. The participants can not be pregnant, have history of scaring/healing problems, autoimmune diseases, severe dermatological conditions, have metal implants, be obese, or have important comorbidities.
Detailed description
Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking. Eligible patients will be approached, the study aims, objectives, procedures, and voluntary participation will be explained. In case patient consent to participate, a written informed consent will be signed. The patients will be comprehensively evaluated by the plastic surgeon, and the areas selected for Quantum use, will be chosen according to the degree of skin laxity of the anatomical region. Data Collection: * Demographic, Clinical, and surgical variables are going to be collected in an Excel-based password protected database. * Other procedure related variables are also going to be collected in the same database, hemoglobin and hematocrit levels, time to discharge, and complications. * The effect of the intervention in the skin laxity will be measured with Elastometer after liposculpture before Quantum, right after Quantum use, 1, 3 and 6 months post procedure. Variables to collect will include area, skin thickness, elasticity, viscoelasticity, and time to retraction. * Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively. * Photographical records will be kept with images pre procedure, and at follow up 1, 3, and 6 months. The study procedures include: * Procedure: All patients will undergo the standardized HD Liposculpture technique. Measurements of skin laxity will be performed with the Elastometer. Using the same ports of Liposculpture, Quantum device will be inserted, and the radiofrequency energy used in recommended parameters (energy 15 J, pulse mode 3.0 pps). Once the procedure is finished, with the patient still in operating table take the first post-treatment skin laxity measurements. * Post procedure follow up: Skin laxity measurements with Elastometer in 1, 3, and 6 months postoperative controls. Study Locations: Dhara Clinic (Bogota, Colombia) Ethical Considerations: * IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB). * Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained. * Data Confidentiality: All participant data will be anonymized and securely stored.
Interventions
DEVICEQuantum RF
Patented handpiece device designed for skin rejuvenation and tightening through intraoperative subdermal Radiofrequency treatment.
Sponsors
Total Definer Research Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will receive Quantum Radiofrequency device as intervention in the anatomical areas were the skin laxity requires treatment. The skin laxity variables will be collected for all the areas at baseline (after liposculpture), immediate after Quantum, and during follow up months 1, 3, and 6.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 dermolipectomy. * Healthy patients without underlying comorbidities (classified as ASA≤II)
Exclusion criteria
* Pregnant patients, patients planning to get pregnant, or in breastfeeding stage * Past medical history of any collagen disease or autoimmune conditions, including lupus, scleroderma, connective tissue disorders, rheumatoid arthritis, or multiple sclerosis. * Past medical history of skin disease including active skin infections, dermatitis, or history of keloid formation. * Patient with any metal implants or pacemakers * BMI ≥ 32 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin elasticity | 6 months | Objectively calculate using Elastometer the difference in the skin elasticity measures pre Quantum use (but after liposculpture procedure), immediate after Quantum use, and in the postoperative follow up on the 1st, 3rd and 6th month. |
| Skin Viscoelasticity | 6 months | Objectively calculate using Elastometer the difference in the skin viscoelasticity measures pre Quantum use (but after liposculpture procedure), immediate after Quantum use, and in the postoperative follow up on 1st, 3rd and 6th month |
| Skin retraction time | 6 months | Objectively calculate using Elastometer the difference in the retraction time measures pre Quantum use (but after liposculpture procedure), immediate after Quantum use, and in the postoperative follow up on 1st, 3rd and 6th month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 6 months | Patient-reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS) for the reduction of skin laxity, and improvement of the appearance. 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. |
Countries
Colombia
Contacts
Primary ContactAlfredo Hoyos, Plastic Surgeon
Backup ContactMauricio Perez, MD
Outcome results
None listed