Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Total Definer Research Group
Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking. 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. 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 assigned to a group based on their individual physical evaluation findings: Cellulite Group, Fibrosis Group, Fibrosis and Cellulite Group. Study Locations: * Dhara Clinic (Bogota, Colombia) * Miami Aesthetic Center (Miami, FL - USA) 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, including pain assessment in the immediate postoperative, hemoglobin and hematocrit levels, time to discharge, and complications \& management. * 3D photographic analysis will be employed to analyze preoperative, and postoperative images at 1, 3, 6 and 9 months post procedure. Then the changes will be objectively compared using Quantificare Photographical Software, through the different timepoints to evaluate the objective contour defects and postoperative improvement changes. * Satisfaction Scores: Global Aesthetic Improvement Scale (GAIS) evaluated at least 3 months postoperatively.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
