Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following facelift surgery. Subjects will receive a total of 3 treatments of their surgical scars at 1-month intervals. Subjects will be followed up at 10 months after their last treatment (12 months after the first treatment).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Fractional radiofrequency will be delivered to the area of the surgical scar.
Ocean Clinic
Marbella, Spain
Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse).
Time frame: 12 months
Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.
Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar for pain, itching, color, stiffness, thickness, and appearance compared to their normal skin using a numbered scale. The scale ranges from 7 (no scar) to 70 with higher scores being worse and suggesting a worse scar.
Time frame: 12 months
Subject Satisfaction With Treatment
Subjects will use the 5-point Likert Satisfaction scale where 4 is very satisfied, 3 is satisfied, 2 is having no opinion, 1 is unsatisfied and 0 is very unsatisfied to evaluate their satisfaction with the treatment.
Time frame: 12 months
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