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Renuvion氦等离子体改善大量减重后接受腹壁成形术患者皮肤松弛外观的疗效:一项前瞻性对照随机研究。

Efficacy of Renuvion Helium Plasma to Improve the Appearance of Loose Skin in Patients Undergoing Abdominoplasty After Massive Weight Loss: A Prospective Controlled Randomized Study.

作者信息

Barone Mauro, Salzillo Rosa, De Bernardis Riccardo, Brunetti Beniamino, Tenna Stefania, Persichetti Paolo

机构信息

Plastic, Reconstructive and Aesthetic Surgery Department, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Roma, Italy.

出版信息

Aesthetic Plast Surg. 2025 Apr;49(8):2260-2268. doi: 10.1007/s00266-024-04655-1. Epub 2025 Jan 15.

Abstract

INTRODUCTION

Renuvion was the first FDA approved helium plasma device utilized for subdermal tissue heating to reduce skin laxity. The purpose of this study was to demonstrate that the use of Renuvion improves the outcomes, skin quality and reduces the edema faster after lipoabdominoplasty.

MATERIALS AND METHODS

Patients with abdominal skin laxity after a weight loss of at least 20 kg, nonsmokers, without major comorbidities, with a minimum 2-year follow-up and standardized pre- and postoperative photographs were included in this study. They were randomly divided in two groups: group 1, lipoabdominoplasty alone; group 2, lipoabdominoplasty and Renuvion. Both the patients and two of the authors measuring outcomes were blinded to the treatment methods. Postoperatively, all patients were administered the BODY-Q satisfaction with abdomen and appraisal of excess skin scales. Two independent plastic surgeons reviewed photographs, rating the outcomes on a 1-5 visual analog scale (VAS). Pinch test and ultrasound of the subcutaneous tissue were also performed.

RESULTS

Seventy-six patients were enrolled, 33 males and 43 females, aged between 20 and 50 years. The BODY-Q satisfaction with abdomen scores were higher in group 2 in the 6-month (p = 0.007), 1-year (p = 0.021) and 2-year (p = 0.024) evaluations. The BODY-Q appraisal of excess skin scores were significantly higher in group 2 in the 6-month (p < 0.0001), 1-year (p < 0.0001) and 2-year (p < 0.0001) postoperative evaluations. The VAS scale reported higher scores in group 2 (p = 0.01). Ultrasound at 6 months postoperatively demonstrated lower subcutaneous thickness in group 2 (31 mm ± 2.8 SD) compared to group 1 (42 mm ± 1.4 SD) implying a faster edema reabsorption.

CONCLUSIONS

Data showed a significantly greater improvement of abdominal skin laxity in patients treated with Renuvion compared to those who underwent lipoabdominoplasty alone. This is the first prospective randomized study about Renuvion and lipoabdominoplasty and could be considered a pilot study.

LEVEL OF EVIDENCE V

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

引言

Renuvion是首个获得美国食品药品监督管理局(FDA)批准的用于皮下组织加热以减轻皮肤松弛的氦等离子体设备。本研究的目的是证明Renuvion的使用可改善抽脂腹部整形术后的效果、皮肤质量,并更快减轻水肿。

材料与方法

本研究纳入了体重减轻至少20千克后出现腹部皮肤松弛、不吸烟、无重大合并症、至少随访2年且有标准化术前和术后照片的患者。他们被随机分为两组:第1组,单纯抽脂腹部整形术;第2组,抽脂腹部整形术联合Renuvion。患者以及两名评估结果的作者均对治疗方法不知情。术后,所有患者均接受了腹部BODY-Q满意度和多余皮肤量表评估。两名独立的整形外科医生查看照片,以1-5视觉模拟量表(VAS)对结果进行评分。还进行了捏皮试验和皮下组织超声检查。

结果

共纳入76例患者,其中男性33例,女性43例,年龄在20至50岁之间。在6个月(p = 0.007)、1年(p = 0.021)和2年(p = 0.024)的评估中,第2组的腹部BODY-Q满意度得分更高。在术后6个月(p < 0.0001)、1年(p < 0.0001)和2年(p < 0.0001)的评估中,第2组的多余皮肤BODY-Q评估得分显著更高。VAS量表显示第2组得分更高(p = 0.01)。术后6个月的超声检查显示,第2组的皮下厚度(31毫米±2.8标准差)低于第1组(42毫米±1.4标准差),这意味着水肿吸收更快。

结论

数据显示,与单纯接受抽脂腹部整形术的患者相比,接受Renuvion治疗的患者腹部皮肤松弛的改善更为显著。这是关于Renuvion和抽脂腹部整形术的第一项前瞻性随机研究,可被视为一项试点研究。

证据水平V:本刊要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述,请参阅目录或在线作者指南www.springer.com/00266

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