Randomized Double-Blind Controlled Study on the Safety and Efficacy of a Novel Injectable Cross-linked Hyaluronic Gel for the Correction of Moderate-to-Severe Nasolabial Wrinkles.

INTRODUCTION: The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles. MATERIALS AND METHODS: This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6 months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness. RESULTS: Complete data were available for 59 subjects. At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34 days (Ial System Duo) and 277 ± 34 days (Belotero Basic/Balance; Student's t test: p = 0.2181). No significant differences were observed with regard to the subject's satisfaction and adverse events. CONCLUSIONS: The Ial System Duo achieves long-term permanence (more than 9 months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction. LEVEL OF EVIDENCE II: 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 .

Chemotherapy Extravasation Management: 21-Year Experience.

Chemotherapy extravasation may result in serious damage to patients, with irreversible local injures and disability. Evidence-based standardization on extravasation management is lacking and many institutions do not practice adequate procedures to prevent the severer damages. Our aim was to explore the prevention and treatment of extravasation injuries, proposing a standard therapeutic protocol together with a review of the literature. From January 1994 to December 2015, 545 cases were reviewed (age range, 5-87 years; 282 men and 263 women). Our therapeutic protocol consisted of local infiltration of saline solution and topical occlusive applications of corticosteroids. The infiltrations were administrated 3 to 6 times a week depending on damage severity. Our protocol allowed us to prevent ulceration in 373 cases. Only 27 patients required surgery (escarectomy, skin graft, regional, and free flap). Numerous treatments have been proposed in literature. The antidotes have been discussed controversially and are not considered standard methods for treatment, especially when polychemotherapy is administrated and the identification of the responsible drug is not possible. We proposed the use of saline solution injection to dilute rapidly the drug, thus reducing its local toxic effects. This method is easy to use and always reproducible even when the drug is not known or when it is administrated in combination with other drugs. It is possible to perform it in ambulatory regimen, and, overall, it represents a standard method.

Clinical, histological, and ultrasound follow-up of breast reconstruction with one-stage muscle-sparing "wrap" technique: A single-center experience.

BACKGROUND: Prepectoral implant placement and complete coverage with porcine acellular matrix after mastectomy is a new concept in breast surgery presented in few cases in the literature. This paper aimed to present our single-center experience in one-stage breast reconstruction muscle-sparing "wrap" technique by evaluating clinical and aesthetic outcomes, ultrasound and histological examination, and patient quality of life. METHODS: From January 2014 to January 2017, 52 patients (40 unilateral, 12 bilateral) underwent one-stage muscle-sparing breast reconstructions with Braxon® acellular dermal matrix and implant. In 3 patients, a surgical biopsy and histological examination with immunohistochemical analysis of the periprosthetic tissue were performed. All patients underwent breast ultrasound examination, and the occurrence of capsular contracture was assessed through the Baker classification and by measuring the mammary compliance scores with the Antoon Paar Mammary compliance system. Breast appearance was evaluated using a visual analogue scale (VAS) and in terms of quality of life using the EOCRT QLQ C-30 and QLQ BR-23 questionnaires. RESULTS: Early and late postoperative complications are reported. Histological and ultrasound evaluation showed a complete integration of the matrix. According to the VAS scale, the EOCRT QLQ C-30, and QLQ BR-23, patients' satisfaction resulted in a high score in terms of quality of life and aesthetic outcomes. CONCLUSION: The results of this new surgical technique in selected cases are promising in terms of effectiveness and low rate of postoperative complications, but further long-terms evaluations are required.

Safety and Patient Satisfaction of AbobotulinumtoxinA for Aesthetic Use: A Systematic Review.

A systematic review of the published literature (from January 2000 to January 2016) to ascertain the safety of, and patient satisfaction with, the aesthetic use of abobotulinumtoxinA was conducted. In addition to the licensed indications, other special populations were considered for discussion. The potential impact of neutralizing antibodies and systemic toxicity were also addressed. A total of 364 papers were screened and 86 were found to be relevant to the population, intervention(s), and outcomes stipulated in the protocol. The safety and patient satisfaction data from these publications are discussed in this review.

Improvement of Mouth Functional Disability in Systemic Sclerosis Patients over One Year in a Trial of Fat Transplantation versus Adipose-Derived Stromal Cells.

Background. Systemic sclerosis (SSc) is a multisystem disease characterized by cutaneous and visceral fibrosis. Face and mouth changes include telangiectasia, sicca syndrome, and thinning and reduction of mouth width (microcheilia) and opening (microstomia). We applied autologous fat transplantation compared with autologous adipose-derived stromal cells (ADSCs) injection to evaluate the clinical improvement of mouth opening. Methods. From February to May 2013 ten consecutive SSc patients were enrolled from the outpatient clinic of Plastic Surgery Department of Sapienza University of Rome. Patients were divided into two groups as follows: 5 patients were treated with fat transplantation and 5 patients received infiltration of ADSCs produced by cell factory of our institution. To value mouth opening, we use the Italian version of Mouth Handicap in Systemic Sclerosis Scale (IvMHISS). Mouth opening was assessed in centimetres (Maximal Mouth Opening, MMO). In order to evaluate compliance and physician and patient satisfaction, we employed a Questionnaire of Satisfaction and the Visual Analogic Scale (VAS) performed before starting study and 1 year after the last treatment. Results and Conclusion. We noticed that both procedures obtained significant results but neither one emerged as a first-choice technique. The present clinical experimentation should be regarded as a starting point for further experimental research and clinical trials.

The Use of Human Adipose-Derived Stem Cells in the Treatment of Physiological and Pathological Vulvar Dystrophies.

"Vulvar dystrophy" is characterized by chronic alterations of vulvar trophism, occurring in both physiological (menopause) and pathological (lichen sclerosus, vulvar graft-versus-host disease) conditions. Associated symptoms are itching, burning, dyspareunia and vaginal dryness. Current treatments often do not imply a complete remission of symptoms. Adipose-Derived Stem Cells (ADSCs) injection represents a valid alternative therapy to enhance trophism and tone of dystrophic tissues. We evaluated efficacy of ADSCs-based therapy in the dystrophic areas. From February to April 2013 we enrolled 8 patients with vulvar dystrophy. A biopsy specimen was performed before and after treatment. Digital photographs were taken at baseline and during the follow-up. Pain was detected with Visual Analogue Scale and sexual function was evaluated with Female Sexual Function Index. All patients received 2 treatments in 3 months. Follow-up was at 1 week , 1 and 3 months, and 1 and 2 years. We obtained a significant vulvar trophism enhancement in all patients, who reported pain reduction and sexual function improvement. Objective exam with speculum was easy to perform after treatment. We believe ADSCs-based therapy finds its application in the treatment of vulvar dystrophies, since ADSCs could induce increased vascularization due to their angiogenic properties and tissue trophism improvement thanks to their eutrophic effect.

Extracorporeal Shock Wave Therapy: An Emerging Treatment Modality for Retracting Scars of the Hands.

Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in a pathologic scar. We evaluated the efficacy of unfocused shock wave treatment, alone or in combination with manual therapy, on retracting scars on the hands. Scar appearance was assessed by means of the modified Vancouver Scar Scale; functional hand mobility was evaluated using a range-of-motion scale, whereas a visual analogue score was implemented for detecting any improvements in referred pain. Additionally, biopsy specimens were collected for clinico-pathologic correlation. For each active treatment group, statistically significant improvements in modified Vancouver Scar Scale were recorded as early as five treatment sessions and confirmed 2 wk after the last treatment session. Analogous results were observed when assessing pain and range of movement. Histopathological examination revealed significant increases in dermal fibroblasts in each active treatment group, as well as in neoangiogenetic response and type-I collagen concentration.

Reconstruction after skin cancer excision through a dermal induction template: our experience.

Dermal substitutes offer alternative approaches for wounds of all thicknesses where sufficient donation sites are not available for self-grafts. Several dermal substitutes are described in literature. This study included 20 patients treated with a dermal induction template after the removal of malignant skin cancers situated in various parts of the body. The participants were especially aged patients with multiple skin cancers, and complex clinical conditions, often affected by pathologies such as cardiopathy, diabetes mellitus, and hypercholesterolaemia, and receiving pharmacological multi-therapies, particularly antiplatelets and anticoagulants. In many of these patients, the general complex clinical picture provided significant contraindication for complex reconstructive surgery because of the high risk involved. All patients achieved complete healing about 8 weeks after the first surgery. By using a dermal induction template, it was possible to cover substantial loss of substances without the need of autologous tissue, with smoother and less apparent scar, minor occurrence of hypertrophic and retracted scars, better flexibility of healed skin and therefore a better result from an aesthetic point of view.

Non-surgical treatment of deep wounds triggered by harmful physical and chemical agents: a successful combined use of collagenase and hyaluronic acid.

Some chronic ulcers often occur with slough, not progressing through the normal stages of wound healing. Treatment is long and other therapies need to be performed in addition to surgery. Patients not eligible for surgery because of ASA class (American Society of Anesthesiologists class) appear to benefit from chemical therapy with collagenase or hydrocolloids in order to prepare the wound bed, promoting the healing process. We describe four cases of traumatic, upper limb deep wounds caused by different physical and chemical agents, emphasising the effectiveness of treatment based on topical application of collagenase and hyaluronic acid (HA) before standardised surgical procedures. We performed careful disinfection of lesions combined with application of topical cream containing hyaluronic acid, bacterial fermented sodium hyaluronate (0·2%w/w) salt, and bacterial collagenase obtained from non-pathogenic Vibrio alginolyticus (>2·0 nkat1/g). In one patient a dermo-epidermal graft was used to cover the wide loss of substance. In two patients application of a HA-based dermal substitute was done. We obtained successful results in terms of wound healing, with satisfactory aesthetic result and optimal recovery of the affected limb functionality. Topical application of collagenase and HA, alone or before standardised surgical procedures allows faster wound healing.

Diabetic foot infection treatment and care.

Foot infections in diabetic patients are a common, complex and costly problem. They are potentially adverse with progression to deeper spaces and tissues and are associated with severe complications. The management of diabetic foot infection (DFI) requires a prompt and systematic approach to achieve more successful outcomes and to ultimately avoid amputations. This study reviews a multi-step treatment for DFIs. Between September 2010 and September 2012, a total of about 37 patients were consulted for DFI. The treatment algorithm included four steps, that is, several types of debridement according to the type of wound, the application of negative pressure therapy (NPT), other advanced dressings, a targeted antibiotic therapy local or systemic as the case may, and, if necessary, reconstructive surgery. This treatment protocol showed excellent outcomes, allowing us to avoid amputation in most difficult cases. Only about 8% of patients require amputation. This treatment protocol and a multidisciplinary approach with a specialised team produced excellent results in the treatment of DFI and in the management of diabetic foot in general, allowing us to improve the quality of life of diabetic patients and also to ensure cost savings.

The effect of post-mastectomy radiation therapy on breast implants: Unveiling biomaterial alterations with potential implications on capsular contracture.

Post-mastectomy breast reconstruction with expanders and implants is recognized as an integral part of breast cancer treatment. Its main complication is represented by capsular contracture, which leads to poor expansion, breast deformation, and pain, often requiring additional surgery. In such a scenario, the debate continues as to whether the second stage of breast reconstruction should be performed before or after post-mastectomy radiation therapy, in light of potential alterations induced by irradiation to silicone biomaterial. This work provides a novel, multi-technique approach to unveil the role of radiotherapy in biomaterial alterations, with potential involvement in capsular contracture. Following irradiation, implant shells underwent mechanical, chemical, and microstructural evaluation by means of tensile testing, Attenuated Total Reflectance Fourier Transform InfraRed spectroscopy (ATR/FTIR), Scanning Electron Microscopy (SEM), high resolution stylus profilometry, and Time of Flight Secondary Ion Mass Spectrometry (ToF-SIMS). Our findings are consistent with radiation-induced modifications of silicone that, although not detectable at the microscale, can be evidenced by more sophisticated nanoscale surface analyses. In light of these results, biomaterial irradiation cannot be ruled out as one of the possible co-factors underlying capsular contracture.

Multiple timescales of body schema reorganization due to plastic surgery.

Plastic surgery modifies the distribution of mass centers of a person's body segments, changing his or her posture. The functional reorganization processes that lead subjects to re-integrate these body changes into a new stable body (posture) schema is poorly understood but current theories suggest the possible contribution of two components: a feedback mechanism that strongly depends on sensory input and an internal model that is relatively less dependent on sensory input and improves posture control, for example by compensating for delayed feedback. To assess the relative contributions of these two mechanisms during the functional reorganization of a posture scheme, we have conducted a longitudinal postural study in a population of healthy adults who were subject to breast plastic surgery to reduce or augment body weight. We measured participants' orthostatic posture and ground reaction force immediately after, after 4 months, and 1 year after the surgery. To investigate the role of visual sensory information in the reorganization process we tested the participants with eyes open and closed. Our results indicate that participants find a new dynamical equilibrium within a few days. However, posture maintenance remains sub-optimal long after the center of masses and the resultant of ground reaction force stop changing; in some cases, for more than 4 months. Furthermore, the re-adaptation process is faster and more efficient in the eyes-open than in the eyes-closed condition. These results suggest that the reorganization involves different subsystems (responsible for the biomechanical changes, the re-calibration of feedback mechanisms, and the re-adaptation of internal models), which act at different timescales.

Clinical Examination and Treatment of a Leg Ulcer Caused by a Stingray Puncture.

The most frequent causes of leg ulcers include venous incompetency (superficial and deep), arterial insufficiency, trauma, vasculitis, and neoplasm. Leg ulcers from injury by stingrays are quite rare. In this case report, we describe a leg ulcer caused by a stingray sting complicated by infection, which healed completely without surgery. In addition, since there few cases in the literature describing such traumas, we performed a comprehensive review of the literature. Important is the fact that the wound healing was complete without resorting to surgery, but only with a correct targeted antibiotic therapy and the use of a collagenase, which has the particularity of having hyaluronic acid as a component.

Retromolar trigone reconstructive surgery: prospective comparative analysis between free flaps.

PURPOSE: Retromolar trigone (RMT) tumours are rare and aggressive malignancies, which require an aggressive surgical approach. The reconstruction oral cavity defects represent a challenge because of the critical role of this area both aesthetically and functionally. Free radial forearm (RF) or anterolateral thigh (ALT) flap are the first choice for the repair of intraoral defects. In reviewing the literature, there is lack of evidence pertaining to the differences between RF and ALT flaps in the reconstruction of patients with RMT tumours. This study evaluates the better microvascular reconstruction after RMT cancer resection. METHODS: Thirty patients with RMT cancer underwent oropharingectomy and microvascular reconstruction using the free RF flap (RF group) and the ALT perforator flap (ALT group). The two groups were homogeneous for sex, age, anatomic area, body mass index, and clinicopathologic profile. Viability, complications, scarring, cosmetic appearance, disorder of sensations, ROM, disease-specific items and satisfaction rate were analyzed, and statistical analysis was performed. STUDY DESIGN: Prospective study. RESULTS: There were differences between the RF and ALT groups in the morphofunctional outcomes, both short-term and long-term follow-up. These differences were statistically significant (p < 0.05) for donor site complications, cosmetic appearance, and scar evaluations. Manual dexterity was slower on the operated donor side than on the nonoperated side in the 33.3 % in the RF group. CONCLUSIONS: The study showed that the free ALT perforator flap provides better results in appearance and scarring than the RF flap for intraoral reconstruction after RMT cancer resection.

Ten years of experience in chronic ulcers and malignant transformation.

Malignant degeneration of wounds is rare and often misdiagnosed. Delay in diagnosis may result in a worse prognosis. The aim of this study is to determine the number of skin cancers associated with chronic skin ulcers in our facility over a period of 10 years. Between January 2002 and December 2012, a total of about 1000 patients had consulted with us for chronic wounds, especially of vascular, diabetic and traumatic origin and pressure ulcers. Thirteen skin cancers had been detected: seven squamous cell and five basal cell carcinomas and one melanoma. We highlight how important it is to be aware of the signs suggesting a malignant change and the importance of biopsy at regular intervals during the life cycle of any chronic wound.