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Efficacy Of Renuvion Helium Plasma To Improve The Appearance Of Loose Skin In Patients Candidate To Abdominoplasty After Massive Weight Loss: Controlled Randomized Study.
Mauro Barone, MD PhD, Rosa Salzillo, MD, Riccardo De Bernardis, MD, Paolo Persichetti, MD PhD;
Fondazione Policlinico Universitario Campus Bio-Medico di Roma, Rome, Italy
Purpose: Renuvion was first helium plasma device utilized for subdermal tissue heating to reduce skin laxity under an FDA general clearance for cutting, coagulation, and ablation of soft tissue. The purpose of this study was to demonstrate that the use of Renuvion improve the outcome, the skin quality and reduce the edema faster.
Methods: Patients meeting the following criteria were included in the study: primary surgical procedure, skin laxity in abdomen region, minimum 2-years follow-up, proficiency in Italian language, signed consent, standardized pre and postoperative photographic documentation. The study was performed with a double-blinded randomized design: both the patients and two of the authors measuring outcomes were blinded to the treatment methods. All patients were asked to answer the BODY-Q satisfaction for skin quality and abdomen appearance. Two plastic surgeons reviewed all postoperative photographs, rating the outcome on a 1-5 VAS scale.
Results: 76 patients were enrolled, 33 males and 43 females, aged between 20 and 50 years. Patients were randomly divided in 2 groups: group 1, lipoabdominoplasty alone; group 2, lipoabdominoplasty using Renuvion also. All procedures were performed by the same time. Both the BODY-Q and VAS scores were higher in groups 2. Edema resolved earlier in group 2.
Conclusions: The data demonstrate benefit to patients by improvement of the appearance of lax skin in the abdominal regione using renuvion. This is the first randomized study about this topic and the use of Renuvion and could be consider a pilot study.
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