Introduction: Hyaluronic Acid (HA) fillers are among the most used products in cosmetic medicine. Companies offer different formulations to allow full facial treatment and/or remodeling. Gels are being studied to establish the biophysical properties behind the specific clinical use and a correlation between the gel biophysical properties and their clinical performance. Clinicians' awareness is growing about the potential benefit deriving from such biophysical characterization. Aim: The Aliaxin ® line of HA dermal fillers is the object of this study. The study aimed to widen the biophysical characterization of these gels by investigating a variety of properties to better support their optimal use. Further, we aimed to provide some clinical findings to gain a deeper insight into the correlation between filler features and clinical outcome. Methods: The four gels of the line were investigated, for the first time, for their cohesivity and stability to Reactive Oxygen Species (ROS). Additional secondary rheological parameters; evidence of relative water-uptake ability; and some clinical findings on product safety, palpability and duration of the aesthetic effect are provided. Results and conclusion: The gels proved highly cohesive and sensitive to ROS action with stability declining with the decrease in the overall gel elasticity. The G* and complex viscosity values at clinically relevant frequencies and gel water-uptake ability are consistent with the relative clinical indication related to gel projection and hydration capacity. Clinical outcomes showed the safety of the products and a perception of palpability well correlating with the cohesive/viscosity properties of the gels. A similar duration of the aesthetic effect (up to 1 year) was observed despite the diverse in vitro gel stability. The results broaden our knowledge of these gels and may contribute to optimize their clinical use towards the improvement of patient safety and satisfaction. Initial clinical observation indicated that gel biophysical properties allow for a reliable prediction of gel palpability, while in vitro data on gel stability cannot be related to the duration of the observed skin improvement. The latter finding further corroborates the idea of a skin restoration process activated by the gels besides the physical volumetric action.
Background. At present, dermal fillers based on hyaluronic acid (HA) represent the most popular intervention of dermoesthetic medicine for the treatment of skin aging. Recent studies have shown that the combination of HA chains of different lengths and molecular weights improves tissue repair and regeneration through a synergistic mechanism. Profhilo® is a product available that has been on the market since 2015 and is based on stable, hybrid, and cooperative complexes (HyCoCos) produced by means of NAHYCO® Hybrid Technology, which is an innovative thermal process that rules out the use of any chemical reagents. The result is a filler with high biocompatibility and low viscosity that favors optimal diffusion at the tissue level to obtain the target bioremodeling of the facial contour. The objective of this review is to provide data from the overall postmarketing experience after 3 years of use and more than 40,000 patients treated with the medical device. Methods. All spontaneous postmarketing adverse event (AE) reports received from physicians and healthcare professionals worldwide between February 9, 2015, and February 8, 2018, associated with the use of the studied medical device and sent to the IBSA global safety database were analyzed. Results. In total, 12 adverse event reports were logged in the global database, and none were considered serious. Early-onset injection site reactions, i.e., swelling, edema, redness, ecchymosis, and erythema, were the most frequently observed. Late-onset local reactions (e.g., swelling, nodules) followed. The genesis of these reactions was considered, both by the reporting physician and IBSA, as being local reactions of hypersensitivity and/or due to inappropriate injection techniques. In no case was the product held liable for direct damage. All events resolved without any complications according to the treatment guidelines. Two late-onset reactions were collected. Conclusions. Although underreporting of minor events cannot be ruled out, the overall number of reports is very low, thereby supporting the high tolerability and safety of the product. After 3 years of postmarketing experience, the safety profile of the studied medical device is favorable and consistent with the product information.
Background Perforator mapping has been well described in the literature. Once the suprafascial plane is reached, the course of perforators is considered constant. However, the surgeon must be aware of whether an anastomosis exists between perforators superficially to the fascia, in order to choose the best vessel upon which to base the reconstruction. Our retrospective in vivo anatomical study of lower leg perforator flaps presents the first description of variations in the suprafascial path of perforators, which may influence preoperative flap design. Methods An anatomical study of lower limb perforators was performed on 46 nonconsecutive patients who were referred to our department from June 2012 to October 2018. Reconstruction with perforator-based propeller flaps was planned for each of the patients. In total, 72 perforators were preoperatively identified and surgically isolated. The suprafascial course of each perforator was reported. Results During suprafascial surgical exploration, branching patterns were observed in four perforators. These perforators had been classified as single vessels in the preoperative ultrasonographic analysis. However, after surgical dissection, distal converging branches were noted in two of them. Conclusions Our study is the first description in the literature of suprafascial converging perforators, which might constitute an obstacle to planned reconstruction procedures. Despite the accuracy of preoperative evaluations, anatomical variations were present. Knowledge of suprafascial perforator variations may help surgeons to choose the correct perforator upon which to base a planned flap.
Prepectoral prosthetic breast reconstruction has been widely reassessed in recent years and is taking on an increasingly important role in the field of immediate breast reconstruction. We report here a case series of 32 patients who underwent nipple-sparing mastectomy for breast carcinoma and prepectoral breast reconstruction involving an acellular dermal matrix (ADM) treated by means of a skin-graft mesher in our hospital from January 2015 to March 2016. The indications for this type of reconstruction were body mass index (BMI) less than 30 kg/m2; no history of radiotherapy; no active smokers; moderate grade breast; and good viability of mastectomy flap: normal skin colour, active bleeding at the fresh cut edges, and thicker than 1 cm mastectomy flaps; the viability of lower thicknesses was ascertained by the fluorescent dye indocyanine green xenon-based imaging technology (4 patients). The mean age of the patients was 56.4 years (range: 39-77 years). Their mean BMI was 27.4 kg/m2. Until the end of follow-up (mean: 17 months), major complications requiring reoperation occurred in 9% of patients and minor complications in 22% of patients. The mean of the 3 pain visual analogue scale scores taken in the first 24 hours after surgery was 1.8. Mean duration of hospital stay has been 2.2 days. Our complication rate was similar to those reported in other studies on prepectoral breast reconstruction featuring total ADM coverage of the implant.
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