Clinical outcomes and patient satisfaction after S.I.H technology®: follow-up of 258 patients.

BACKGROUND: Aging is a natural process. The association between the gradual loss of tissue integrity and the force of gravity determines a condition from which it is complex to go back. The approval by the American FDA of the monopolar radiofrequency (Thermage®) dates back to 2002. Since then, innovation has made great strides up to the development of endodermal technology in recent years which allows subcutaneous probes to act with precision and under careful control on the treated areas. METHODS: We retrospectively reported our experience in rejuvenation treatments of the face and of different areas of the body using the Subdermal Induced Heat (S.I.H.) technology®, featuring a population of 258 patients who received 502 treatments between 2018 and 2022. Clinical outcomes and patient satisfaction were assessed, respectively by analyzing adverse events and complications at 7 days from treatment, and patient-reported outcome at 3, 6 and 12 months using a 5-point Likert Scale. RESULTS: Only 25 complications were reported, of which 68% consisted in bruising, 24% in hematomas and 8% in edema. Most patient were reportedly satisfied with overall treatment, with 55% of them being "very satisfied" with the results at 6 months from initial procedure. CONCLUSIONS: We highlight the manageability of the S.I.H. technology which has been proven to be safe and effective in achieving satisfying results for skin rejuvenation, with a reduced number of sessions required and good maintenance of the results obtained.

Comparison of 2.5% agarose gel vs hyaluronic acid filler, for the correction of moderate to severe nasolabial folds.

BACKGROUND: Agarose gel filler is a natural hydrocolloid with a three-dimensional structure similar to the extracellular matrix, with gel formed by hydrogen bonds and electrostatic interactions rather than through chemical cross-linking or polymerization. OBJECTIVE: To determine efficacy and safety of 2.5% agarose gel filler for the correction of nasolabial folds. METHODS: In this split-face study, efficacy, safety, and usability of 2.5% agarose gel were compared to those of NASHA-L. Assessments included the nasolabial fold (NLF) Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS [blinded investigator]), subject satisfaction, safety (adverse events), and usability. RESULTS: Sixty-six subjects were treated, and 46/66 (66.7%) were available for evaluation at 3 months, when mean change in WSRS was identical for both products (-1.1 ± 0.4 for 2.5% agarose; -1.1 ± 0.4 for NASHA-L). Scores for each product remained similar across all time points and began to return to baseline between 7 and 8 months. GAIS score followed a similar pattern, rising between months 7 and 8 (2.7 ± 0.6 for 2.5% agarose at month 7-3.3 ± 0.5 at month 8 and 2.7 ± 0.6 for NASHA-L at month 7-3.3 ± 0.5 at month 8). Ultrasound confirmed the longevity of both fillers between 7 and 8 months. All adverse events were transient in nature and resolved within 15 days. Most events were mild in nature, and the number of events was similar between the two fillers. CONCLUSION: Treatment with 2.5% agarose gel resulted in improvement that persisted for between 7 and 8 months. The treatment effect was equivalent to NASHA-L.

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.

Medical and Surgical Treatment of Hidradenitis Suppurativa: A Review.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease presenting with painful nodules, abscesses, sinus tracts, and scarring primarily affecting apocrine gland-rich intertriginous areas. HS prevalence ranges from 0.05 to 1%. The central pathogenic event in HS is believed to be the occlusion of the upper part of the folliculopilosebaceous unit, leading to the rupture of the sebofollicular canal with the consequent development of perifollicular lymphohistiocytic inflammation. The HS treatment choices are influenced by disease severity and its individual subjective impact, involving both medical and surgical interventions. However, given the chronic nature of HS, its destructive impact on social, working, and daily life of patients, its management is often frustrating for both the patient and physician. Hence, prompt and effective management strategies are urgently needed and a multidisciplinary approach is advocated. Therefore, in this article, we highlighted the main features of HS (clinical aspects, epidemiology, pathogenesis, diagnostic criteria, classifications, comorbidities, and treatments), so that awareness of this disease might be heightened in primary care physicians and surgeons, who may be the first health care providers to see patients with this disease owing to its characteristic clinical presentation (inflammatory nodules, abscesses, sinus tract, etc.).

Bifid median nerve and carpal tunnel syndrome: an uncommon anatomical variation.

Dear sir, one of the most common entrapment neuropathy syndromes in clinical practice is "Entrapment of median nerve in carpal tunnel" also called "Carpal tunnel syndrome (CTS)" (Aydin et al., 2007; Huisstede et al., 2010). This syndrome is caused by entrapment of the median nerve in the wrist (Preston and Shapiro, 2005) when the pressure increases in the carpal tunnel. A high division of the median nerve proximal to the carpal tunnel, also known as a bifid median nerve, is a rare anatomic variation that may be associated with CTS and with persistent median vessels (Lanz, 1977). This anatomic variation has an incidence of 0,8% to 2,3% in patients with CTS. Lanz (1977) has characterized this anatomic condition of the median nerve in the carpal tunnel. These anatomic variants have been classified into four groups: - Group 0: extraligamentous thenar branch (standard anatomy); - Group 1: variations of the course of the thenar branch; - Group 2: accessory branches at the distal portion of the carpal tunnel; - Group 3: divided or duplicated median nerve inside the carpal tunnel; - Group 4: accessory branches proximal to the carpal tunnel. During dissection of the wrist performed for the treatment of a CTS under local anesthesia, we found an anatomical variation of the median nerve that was divided in two branches inside the carpal tunnel (Group 3 of Lanz Classification) and in which its radial branch passed through its own compartment. The two parts of the nerve seems to be unequal in size (Fig. 1). Moreover the nerve passed in carpal tunnel associated with a median artery, so we classified this variation in the group 3b of Lanz Classification (Fig. 2). The persistence of median artery coexisting with a bifid median nerve has been widely reported in surgical literature (Lanz, 1977; Barbe et al., 2005). Before surgical intervention clinical evaluation of patient and electrophysiological examination showed no differences compared to a non bifid median nerve entrapment syndrome. In conclusion the bifid median nerve may facilitate compression of median nerve in the carpal tunnel because of its increased cross sectional area even if it has no electrophysiological or clinical differential diagnosis in case of CTS. The aim of this letter is aware the physicians in order to borne in mind the possible presence of a median nerve variation during dissection of carpal tunnel in order to avoid the damage of this non common anatomical structures.

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.

A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation.

PURPOSE: Many treatment modalities exist to counteract the effects of cutaneous aging. Ablative methods have been the mainstay for nonsurgical facial rejuvenation. In recent years, nonablative techniques have been developed with the aim of achieving facial rejuvenation without epidermal damage. Light-emitting diode (LED) photorejuvenation is a novel nonablative technique that induces collagen synthesis through biophotomodulatory pathways. MATERIALS AND METHODS: A single-center, randomized, single-blinded, placebo-controlled, split-faced clinical trial was designed. Thirty-two patients were enrolled for a 12-week study. Patients were randomized into one of four groups: Group A, treatment with KLOX-001 gel formulation and white LED (placebo) light; Group B, treatment with a placebo/base gel (no active chromophore) formulation and KLOX LED light; Group C, treatment with KLOX-001 gel formulation and KLOX LED light; and Group D, treatment with the standard skin rejuvenating treatment (0.1% retinol-based cream). Patients received treatment at weeks 0, 1, 2, and 3, and returned to the clinic at weeks 4, 8, and 12 for clinical assessments performed by an independent, blinded committee of physicians using subjective clinician assessment scales. Tolerability, adverse outcomes, and patient satisfaction were also assessed. RESULTS: Analysis demonstrated that the KLOX LED light with KLOX placebo/base gel and the KLOX LED light + KLOX-001 gel formulation groups were superior to standard of care and KLOX-001 gel formulation with placebo light on subjective clinical assessment and multiple wrinkle scales, with statistically significant results obtained for brow positioning, perioral wrinkling, and total wrinkle score. CONCLUSION: The study results show that KLOX LED light with KLOX-001 gel formulation and KLOX LED light with KLOX placebo/base gel are effective, safe, well-tolerated, and painless treatment modalities for skin rejuvenation.

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.

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.

Effect of enzymatic debridement with two different collagenases versus mechanical debridement on chronic hard-to-heal wounds.

A chronic ulcer is usually defined as an injury that does not spontaneously evolve towards healing and does not progress through normal healing stages such as inflammation, proliferation and remodelling. This study was designed in order to compare two types of collagenases with mechanical debridement alone. It was thus possible to evaluate their differences in terms of pain and debridement efficacy. Patients were divided into three groups: 30 patients were daily dressed using an ointment based on collagenase produced by Vibrio alginolyticus (B group), 30 patients were daily dressed using an ointment based on a collagenase preparation derived from Clostridium histolyticum (N group) and 30 patients underwent classical mechanical debridement (M group). Complete wound healing over a period of 8 weeks occurred in 24 patients (27%) out of 90;10 patients belonging to the B group, 8 patients to the N group and 6 patients to the M group. This study was performed in order to highlight the differences between two commercially available collagenase-based ointments in comparison with mechanical debridement alone. At the final time point of week, the difference in the percentage of debridement was not statistically significant in all groups, but at 4 weeks, the debrided area in the B group was larger with respect to the N and M groups, suggesting a more rapid wound bed cleansing process. On the basis of our experience, collagenase derived from V. alginolyticus with hyaluronic acid showed chemical and physical properties that make it a product of great manageability and ensure the protection of peri-wound skin. Moreover, less pain was experienced by the patients.