EUREKA study - the evaluation of real-life use of a biophotonic system in chronic wound management: an interim analysis Marco Romanelli,1 Alberto Piaggesi,2 Giovanni Scapagnini,3 Valentina Dini,1 Agata Janowska,1 Elisabetta Iacopi,2 Carlotta Scarpa,4 Stéphane Fauverghe,5 Franco Bassetto4 1Wound Healing Research Unit, Division of Dermatology, School of Medicine, University of Pisa, Pisa, 2Diabetic Foot Section, Department of Medicine, University of Pisa, Pisa, 3Department of Medicine and Health Sciences, School of Medicine, University of Molise, Campobasso, 4Clinic of Plastic and Reconstructive Surgery, Padova University-Hospital, Padova, Italy; 5KLOX Technologies Inc., Laval, QC, Canada Objective: Interest has grown regarding photobiomodulation (PBM) with low-level light therapy, which has been shown to positively affect the stages of the wound healing process. In a real-life context clinical setting, the objective of the EUREKA study was to investigate efficacy, safety, and quality of life associated with the use of a BioPhotonic gel (LumiHealâ?¢) in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs). This BioPhotonic gel represents a new, first-in-class emission spectrum of light, including fluorescence, to induce PBM and modulate healing.Design: The multicenter, prospective, interventional, uncontrolled, open-label study enrolled 100 patients in 12 wound centers in Italy. We performed an early interim analysis based on the first 33 subjects (13 VLU, 17 DFU, 3 PU) in seven centers who completed the study.Main results: Seventeen patients (52%) achieved total wound closure (full re-epithelialization for 2 weeks) during the study period. Two patients (6%) were considered â??almost closedâ?? (decrease of the wound area of more than 90% at study end) and three others (9%) were considered â??ready for skin graftingâ??. No related serious adverse events were observed, and the compliance was excellent. After the treatment, the average time to â??pain-freeâ?? was 11.9 days in the VLU group. Quality of life was improved with overall increase of 26.4% of the total score (Cardiff Wound Impact Schedule, p=0.001).Conclusion: The study revealed a positive efficacy profile of the BioPhotonic gel in promoting wound healing and reactivating the healing process in different types of chronic, hard-to-heal wounds. The treatment was shown to be safe and well tolerated by the patients, and a reduction of pain perception was also detected during the treatment period. The improvement of the quality of life was accompanied by a high level of clinician satisfaction. Keywords: photobiomodulation, fluorescence biomodulation, biophotonics, phototherapy, light, venous leg ulcers, VLUs, pressure ulcers, PUs, diabetic foot ulcers, DFUs, hard-to-heal wounds

Fluorescent light energy (FLE) has been used to treat various injured tissues in a non-pharmacological and non-thermal fashion. It was applied to stimulate cell proliferation, accelerate healing in chronic and acute wounds, and reduce pain and inflammation. FLE has been shown to reduce pro-inflammatory cytokines while promoting an environment conducive to healing. A possible mechanism of action of FLE is linked to regulation of mitochondrial homeostasis. This work aims to investigate the effect of FLE on mitochondrial homeostasis in an in vitro model of inflammation. Confocal microscopy and gene expression profiling were performed on cultures of inflamed human dermal fibroblasts treated with either direct light from a multi-LED lamp, or FLE from either an amorphous gel or sheet hydrogel matrix. Assessment using confocal microscopy revealed mitochondrial fragmentation in inflamed cells, likely due to exposure to inflammatory cytokines, however, mitochondrial networks were restored to normal 24-h after treatment with FLE. Moreover, gene expression analysis found that treatment with FLE resulted in upregulation of uncoupling protein 1 (UCP1) and carnitine palmitoyltransferase 1B (CPT1B) genes, which encode proteins favoring mitochondrial ATP production through oxidative phosphorylation and lipid β-oxidation, respectively. These observations demonstrate a beneficial effect of FLE on mitochondrial homeostasis in inflamed cells.

Background: Due to the great impact of bariatric surgery on the overweight epidemic, the number of post-bariatric body-contouring procedures is constantly increasing worldwide. The portable incisional negative pressure wound therapy (piNPWT) is a promising medical device for accelerating wounds closure and controlling post-operative complication, which have been shown promising results in post-bariatric population. We aimed to evaluate the role of piNPWT in optimizing wound healing and controlling post-operative complications after a post-bariatric brachioplasty. Patients and Methods: 26 post-bariatric female patients who underwent a brachioplasty followed by either a piNPWT (14 cases) or a standard wound treatment (12 controls) were analyzed. The number of post-operative dressing changes, the rate of local post-operative complications (re-operation, hematoma and serosa development, dehiscence and necrosis), the time to dry as well as the scar quality and hospitalization length were evaluated. Results: None of the patients prematurely stopped treatment with piNPWT due to intolerance. The piNPWT patient group showed a significant lower healing time as well as a significant reduction of the number of post-operative dressing changes and hospital stay. Despite the scarring process was excellent from the functional point of view in the long term, we noticed a higher rate of hyperchromic scarring at 90 days after surgery. Conclusion: The piNPWT is a cost-effective and user-friendly medical tool that increase and promote wound healing. We suggest the use of this device in post-bariatric patients who undergo a brachioplasty, especially if there is the need to minimize the number of post-operative dressing changes. Level of Evidence IV: 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 Table of Contents or the online Instructions to Authors www.springer.com/00266.

Silver nanoparticle dressings have gained popularity recently as a way to treat challenging wounds. Notwithstanding the properties of Ag‐NPS (silver nanoparticles) described by several articles, there is a lack of clinical studies that guide healthcare professionals to specific and conscious use. In this case series, Ag‐NPS dressing was tested on a randomized group of 10 patients with complex wounds requiring conservative treatment. Each case was analysed, recording the patient's history, the peculiar characteristics and the progressive changes in the wound. The wound bed and the quality of the peri‐wound skin improved and a decrease in signs of infection was observed. The application of the dressing was simple and comfortable for the patient and it was appreciated for its sealing ability. A few capacity restrictions showed up: those should be read as elements to improve the indications for this peculiar dressing. The thin tissue matrix of the Ag‐NPS dressing does not allow for massive absorption and also performs poorly in reducing little exudate. The reduction in wound width is also limited: reconstructive surgery was required in half of the enrolled patients to achieve wound healing.

Background: Due to the high demand of post-bariatric surgeries, the number of litigation cases is rapidly growing. Even if surgical mistakes still represent one of the main causes of medico-legal issues, many disputes depend on what happens in the post-operative course. In this article we analyzed the litigation cases that occurred in our Plastic Surgery Department, the current literature about medico-legal disputes and the importance of the doctor–patient relationship. Patients and methods: The medical records of 788 post-bariatric surgeries, the post-operative complications and the related litigation cases from January 2015 to December 2019 were collected, analyzed and compared. Results: We performed 380 abdominoplasties, 28 torsoplasties, 65 breast reductions, 99 mastopexies, 94 brachioplasties, 52 thighplasties, 65 liposuctions and 5 facelifts between 2015 and 2019. Eight patients complained of medical issues and claimed for litigation. Despite in all cases the judges highlighted the risk of consent misinterpretation, the payout was granted only in one case. Conclusion: Post-bariatric patients often mistake their preoperative condition and consider body contouring procedures as an aesthetic surgery treatment. Patients should be therefore clearly informed about the complexity of body contouring procedures after massive weight loss, which should never be compared to aesthetic surgery. Surgeons should always promote the communication with their patients and build a strong and trustworthy relationship. This attitude will allow to deal more easily with complications and, in the worst situations, with medico-legal litigations. Level of Evidence IV: 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.

Since the end of the nineteenth century, fat grafting has become one of the most promising treatments for posttraumatic deformities and more in general for scars. Its easy application and collection have made it as the ideal therapy to restore volume and pliability, and contour and to prevent symptoms as pain. In these years the application method, the indications and the guidelines have been changed many times. In this chapter, we analyze why fat grafting is becoming so popular in the twentieth century and what is the scientific rational to use autologous adipose tissue. We will also discuss the current guidelines and the possible applications. At the end, we will also present some new fields such as the application of autologous fat grafting in the treatment of the hypertrophic scars and how we can try to improve its engraftment using external mechanical forces (the external negative pressure therapy) and/or the plasma-rich platelet (PRP).