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The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.
Split-body/face evaluator-blind study of the safety and performance of fractional RF for the treatment of surgical scars following breast augmentation, abdominoplasty or face lift. 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 face lift surgery. Subjects will receive a total of three treatments of their surgical scars at one-month intervals on one side of the body or face only. Subjects will be followed up at one, two, three and ten months after their last treatment. Outcomes will be compared to the non-treated side.
With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.