Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
The study will evaluate up to 20 subjects scheduled to undergo breast reduction or breast mastectomy in which scar assessment can be made after pre-surgical treatment in a split-body design. The study will involve a single treatment of radiofrequency (RF) applied to one side of the surgical area(s) within 24 hours prior to the procedure. The subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. Tissue samples will be biopsied from the RF treated skin, as well as non-treated skin, at follow up visits. The samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.
UT Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, United States
RECRUITINGIndependent blinded assessment
Independent blinded evaluator assessment of the surgical scar sites using the Global Aesthetic Improvement Scale (GAIS), comparing follow-up visit photographs for both the treated and untreated sides.
Time frame: 6-months after treatment
Principle Investigator (PI) evaluation of the scar(s)
PI evaluation of the scar(s) using the Manchester Scar Scale (MSS) at 3 and 6 months post-treatment for both the treated and untreated sides. Non-invasive skin assessments will be evaluated to document scar morphology, scar thickness/density and colorimetry for both the treated and untreated sides.
Time frame: 3- and 6-months after treatment
Subject Satisfaction
Subject satisfaction of treatment using the Subject Satisfaction Scale
Time frame: 3- and 6-months after treatment
Histological Assessment
Histological assessment of the treated and the untreated (control) area.
Time frame: 1-, 3- and 6-months after treatment
Scar Morphology
Scar morphology will be digitally analyzed using 3D photography camera
Time frame: Baseline, 3- and 6-months after treatment
Ultrasonography
High ultrasonography will be used to analyze scar thickness, epidermal thickness and skin density
Time frame: Baseline, 3- and 6-months after treatment
Colorimetry
o Colorimetry assessment will be used to establish a clinically acceptable objective assessment of patients' scars
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Time frame: Baseline, 3- and 6-months after treatment