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.

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.

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.

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.

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.

Evaluation of a new hyaluronic acid dermal filler for volume restoration.

OBJECTIVES: The present study aimed to evaluate the effectiveness and safety of hyaluronic acid gel for the treatment of volume loss or contour deficiency. METHODS: This 6-month, open-label study recruited sixty adults aged 40-65 years with bilateral moderate to severe volume loss or contour deficiency (Facial Volume Loss Scale [FVLS] score: 2-5). Eligible subjects were treated at the baseline visit with an injection of hyaluronic acid gel in one or more of three facial subregions: the zygomatic malar region, the anteromedial cheek and nasolabial folds. RESULTS: A significant improvement from baseline was observed in the FVLS score at each study visit up to 6 months post treatment (p < 0.0125 by Wilcoxon test). A significant improvement was also observed in the Global Aesthetic Improvement Scale (GAIS) at each visit up to 6 months. The study showed that the GAIS score improved in 100% of subjects at month 3, while at the end of the study (month 6) the percentage of improved subjects decreased to 91. Treatment effect was maintained by 100% of subjects up to month 3, while 57% of subjects showed a persistence of effect up to month 6. CONCLUSIONS: Volume loss or contour deficiency may be safely and effectively corrected using the new dermal filler.

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.

Transverse upper gracilis flap with implant in postmastectomy breast reconstruction: a case report.

Autologous flaps can be used in combination with prosthesis in postmastectomy breast reconstruction. The deep inferior epigastric perforator (DIEP) flap is considered the preferred choice among autologous tissue transfer techniques. However, in patients with a peculiar figure (moderately large breasts and large thighs with flat stomach), who cannot use their abdominal tissue, the transverse upper gracilis (TUG) flap with implant is investigated as a further option for breast reconstruction. This report presents a patient who underwent the TUG flap plus implant reconstruction. A bilateral skin-sparing mastectomy was performed removing 340 g for each breast. The volume of the TUG flaps was 225 g (left) and 250 g (right). Preoperative volumes were restored by placing under the TUG muscle a round textured implant. No complications occurred during the postoperative period both in the recipient and donor site and the outcomes of the procedure were good. In cases where the use of the DIEP flap is not possible because of past laparotomies or inadequate abdominal volume, the TUG flap plus implant may be considered as a valid alternative.

Co2/Erbium:YAG/Dye laser combination: an effective and successful treatment for angiofibromas in tuberous sclerosis.

BACKGROUND: Tuberous sclerosis, an autosomal dominant neurocutaneous syndrome seen in approximately 1 in 6,000 people worldwide, is characterized by the appearance of hamartomas in multiple organs. The classic clinical triad consists of angiofibromas, epilepsy, and developmental delay. Dermatologic disorder is one of the main characteristics. Angiofibromas, a common form of presentation, causes significant cosmetic and medical problems. The current treatment for skin lesions is laser therapy. The carbon dioxide (CO2) laser has been used satisfactorily in treating these lesions, but several studies have demonstrated a high percentage of recurrences. Erbium:yttrium-aluminum-garnet (YAG) laser treatment has been used to resurface skin abnormalities in patients with dermatologic conditions. The dye laser as an alternative uses the principles of selective photothermolysis and is very effective in treating the vascular component of tuberous sclerosis. The use of all these lasers to treat skin lesions in patients affected by tuberous sclerosis has never been described in the literature. METHODS: A retrospective study, conducted from 2007 to May 2013, investigated 13 patients who had tuberous sclerosis treated with an erbium:YAG/CO2/dye laser combination. RESULTS: All the patients showed great improvement of their skin lesions. The results were evident immediately after the first treatment. No patient experienced complications or recurrence. CONCLUSIONS: The combined use of the erbium:YAG/Dye/CO2 laser is a safe and effective treatment for skin lesions in patients affected by tuberous sclerosis. 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 .

Evidence-based evaluation technique to assess augmentation mammaplasty results: a simple method to objectively analyze mammary symmetry and position.

BACKGROUND: Despite the great variety of mammaplasty techniques, outcome assessment remains a challenging issue. OBJECTIVES: The authors devised an objective method to evaluate mammary symmetry based on statistical analysis of objective manual breast measurements and validated the method by applying it to results of a randomized controlled trial on the correction of breast asymmetry. METHODS: Sixty consecutive patients with hypoplastic breasts and small-volume asymmetry were enrolled in the study and randomly assigned to 1 of 2 groups. One group received a fixed-volume implant in 1 breast and an adjustable-volume implant in the other. The other group received 2 fixed-volume implants of different sizes. The differences in specific breast and chest measurements, obtained before surgery and during follow-up, were analyzed statistically with the Wilcoxon signed rank test. RESULTS: Correction of the asymmetry resulted in the reduction of the differences between left and right values for each specific breast measurement. Placement of an adjustable implant on 1 side yielded better symmetry than placement of 2 fixed-volume prostheses of different sizes. Patient and physician satisfaction was high for both groups. CONCLUSIONS: This objective analysis of clinical parameters enables comparing results for different patients in large clinical trials and for the same patient at different follow-up periods. LEVEL OF EVIDENCE: 3.

Botulinum toxin type A in the healing of chronic lesion following bilateral spasticity of gluteus muscle.

Use of botulinum toxin is expanding as the clinical studies demonstrate new potential therapeutic applications. In rehabilitation, botulinum toxin is above all used as adjunct therapy for the treatment of spasticity, but it may prove useful for other atypical clinical situations. A 17-year-old man had a sub-arachnoid haemorrhage following the rupture of cerebral aneurism. The patient presented gluteus maximus and medius bilaterally spasticity that produced a chronic lesion in the intergluteal cleft, a flexed wrist and a flexed elbow. As treatment for this spasticity, a total of 100 U botulinum toxin type A were injected into the glutei muscles. This treatment allowed for application of topical medication and subsequently, chronic lesion healing. Botulinum toxin A may be an important therapeutic aid for clinicians faced with treating persistent pathological conditions caused by spasticity.

Skin ulcer caused by venous extravasation of heroin.

The accidental leakage of the compound, in this case heroin, from the veins where it is injected, causes the formation of tissue lesions. Similar mechanisms lead to progressive tissue necrosis, which, if not immediately treated, results in the loss of the relevant function. A 57-year-old man presented a skin lesion on the posterior region of the left forearm with extensive necrosis of skin and subcutaneous layer involving the underlying muscle planes, caused by a venous extravasation of heroin that he reports having injected himself. The wound size is 15 × 10 cm; it had a sanious, fibrinous, secreting and smelly bottom. In this period, the patient was subjected to daily focused dressing before debridement of the lesion through a collagenase plus hyaluronic acid ointment: Bionect Start®; (FIDIA Pharmaceutical, Abano, Italy). The therapeutic choice was rewarded with a complete resolution of the wound through a non-invasive technique and over a short period. Avoiding the hospitalisation of the patient achieved a reduction of risks for him and of the costs for the National Health Service (NHS). The Bionect Start®; (FIDIA Pharmaceutical) as well as allowing the healing of the wound also decreased significantly the pain felt by the patient, the amount of exudate and the bad smell improving in a non-negligible way his quality of life.

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.

Extracorporeal shock wave therapy for the management of burn scars.

BACKGROUND: Hypertrophic and contracture scars are common problems after burn injuries and cause functional and cosmetic deformities. A wide variety of treatments has been advocated for postburn pathologic scars regression. Unfortunately, the reported efficacy has been variable. OBJECTIVES: To investigate the use of extracorporeal shock wave therapy (ESWT), which mainly targets the fibroblasts in scar tissue, as an effective modality for scar treatment in burn patients. MATERIALS AND METHODS: An experimental study with ESWT was performed in 16 patients with postburn scars contractures, hypertrophic scars, or keloids twice a week for 6 weeks. Digital photographs were obtained and visual analogue scales were completed before and after treatment. RESULTS: Already after the first session, scars appeared more pliable, and color mismatch was less evident. At the end of the study period, all treated scars obtained a more acceptable appearance. CONCLUSIONS: Extracorporeal shock wave therapy is a feasible and cost-effective treatment in the management of postburn pathologic scars.

Optimal care for eyelid contraction after radiotherapy: case report and literature review.

Radiotherapy represents a major problem in facial surgery. Orbital and periorbital radiation therapy causes a contraction of the soft tissues. Scarring with ectropion is the most severe complication, with shrinking of the anterior lamella, skin dystrophy, muscle atrophy, and alteration of the remaining soft tissues. Goals for reconstruction include correction of distorted orbitofacial tissues and the restoration of orbital structures. The management of these patients is not standardized. We suggest systematically using a combined approach of surgery and lipofilling to restore the orbital deformity and dystrophy, respectively. For this purpose, we present the case of a 65-year-old woman with asymmetry of the orbital regions and severe lower eyelid cicatricial ectropion due to multiple radiation treatments in childhood for an extensive cavernous hemangioma of the right side of the face. We performed a reconstructive procedure using a tarsal strip technique in association with contralateral upper eyelid graft to correct the extensive retraction of the right lower eyelid and lid asymmetry. Subsequently, the patient underwent lipofilling to correct the post-radiotherapy dystrophy. Skin texture, softness, and elasticity greatly improved with further symmetrization. The combined treatment with surgery and lipofilling can significantly improve the functional and cosmetic outcome of shortened and dystrophic eyelids with a successful result with regard to post-radiotherapy retraction.

A clinical study of late seroma in breast implantation surgery.

BACKGROUND: The use of mammary implants may lead to a variety of early and delayed complications. The most common delayed complications are capsular contracture and implant failure. Late seroma has seldom been reported. In a long-term prospective observational study, cases of late seroma were assessed and recorded. METHODS: Between March 2005 and November 2009, suspected cases of late seroma in patients who had undergone breast augmentation or reconstruction with textured implants were evaluated clinically and with instrumental analyses. An ultrasound-guided needle aspiration of the fluid was performed. RESULTS: In this study, 13 cases of late seroma (8 augmentations and 5 reconstructions) were observed. The overall incidence of this complication was 1.68%. Chemical analyses confirmed the diagnosis of seroma, which recurred in all the patients within days of evacuation. For 12 patients, a reoperation was performed, during which the implant was removed, a total capsulectomy was performed, and in cases of subglandular breast augmentation, the implant pocket was changed to a submuscular placement before a new prosthesis was inserted. One patient underwent a second ultrasound-guided needle aspiration. No seroma recurrence was observed in any of the patients during the follow-up period. CONCLUSION: In case of unexpected breast enlargement after prosthesis implantation, the physician should first rule out infection, then investigate possible friction irritation from either a fold in the device or rubbing of a textured implant. According to the authors' experience and another report, this complication occurs in 1% to 2% of cases. The inclusion of this complication in the informed consent form should be considered. Long-term studies designed to investigate the underlying causes of late seroma are warranted for the prevention and treatment of this complication.