Preliminary Prospective and Randomized Study of Highly Purified Polynucleotide vs Placebo in Treatment of Moderate to Severe Acne Scars.

BACKGROUND: Managing acne scars is a challenge and therapies are divided into nonsurgical and surgical. Highly Purified Technology Polynucleotides (PN-HPT) is a compound that contains a mixture of DNA polymers of different lengths. Numerous studies have shown that PN-HPT also serves as an energy source, thus influencing cellular growth and cell vitality. OBJECTIVES: The authors aimed to assess the improvement in dermal quality and acne scars after PN-HPT vs placebo according to Antera 3D and the patient responses to the patient satisfaction questionnaire after a comparison of pretreatment and posttreatment photographs at 1 and 3 months. METHODS: Included were women aged 30 to 50 years with grade 3 to 4 moderate-to-severe atrophic scars according to the Goodman classification; nonsmokers; and had not had active acne during the past 5 years. Ten patients (PN-HPT group) were treated with 4.0 mL of PN-HPT, and 10 patients (control) were treated with 4.0 mL of normal saline. All medical treatments were performed in a double-blinded manner; neither the injection doctor nor the patient knew if the PN-HPT or the placebo was being administered. RESULTS: Twenty women who fit the inclusion criteria were enrolled in this study. Only patients in the PN-HPT group improved significantly at 1 and 3 months after treatment compared with baseline. CONCLUSIONS: This prospective and randomized study showed that PN-HPT in monotherapy was safe and effective treatment for atrophic scar acne compared with placebo. Prospective and randomized studies will be necessary to investigate the clinical effectiveness in a larger cohort of patients and for a longer follow-up.

Prospective Study on Clinical Efficacy and Safety of a Single Session of Microfocused Ultrasound With Visualization for Collagen Regeneration.

BACKGROUND: Recent studies have shown that transcutaneous microfocused ultrasound with visualization is beneficial for noninvasive skin tightening, collagen regeneration, and lower face contour improvement. OBJECTIVES: The primary study endpoint was the improvement of the laxity and ptosis face skin; the secondary endpoint was the improvement of wrinkles, texture, and hemoglobin content; and the third endpoint was the patient's responses to a patient satisfaction questionnaire. METHODS: Patients with soft to moderate skin laxity and ptosis of the face and neck were enrolled and their sex, ethnicity, age, Fitzpatrick skin type, and smoking habit recorded. Patient assessment was made by digital macro-photographs, Vectra H2, and Antera 3D, and strict exclusion criteria were set up. RESULTS: From November 2017 to November 2018, 47 women and 3 men with a mean age of 52.8 ± 7.43 years and Araco's Ptosis Scale System 2.7 ± 0.46, which fit the inclusion criteria, were enrolled in the study. All patients signed a consent form and received 1200 spot-lines (400 lines from each transducer) of microfocused ultrasound with visualization. No major side effects were reported during the study and all patients completed the follow-up after 6 months. Wrinkles, texture, Surgeon Assessment Scoring System scores, and patient satisfaction questionnaire scores improved significantly. Patients found the treatment tolerable according to the patient pain scale rate. No statistically significative differences were found among homogenous groups of smokers and nonsmokers. CONCLUSIONS: The study proves that microfocused ultrasound with visualization in a single session of treatment in monotherapy is safe and effective for the treatment of face laxity and ptosis when a proper number of energy spot-lines is delivered in the correct tissue layer.

A prospective study comparing topic platelet-rich plasma vs. placebo on reducing superficial perioral wrinkles and restore dermal matrix.

Introduction: The goal of our prospective study was to assess the efficacy of the topical Platelet-rich plasma on reducing superficial perioral wrinkles and restoring the dermal matrix. Materials and methods: 50 women with moderate to severe perioral wrinkles were treated on the perioral area by a single session of fractional CO2 laser skin resurfacing plus intradermal injection of prp. 25 patients (group 1) applied topically prp twice a day for 12 weeks as post laser treatment. 25 (group 2) applied gentamicin and betamethasone twice a day for the first 7 days and then hyaluronic acid gel for the following 12 weeks. Results: In group 1, moisture (p < 0.001), amount of collagen fiber (p < 0.001) skin elasticity (p < 0.001), PSAl (p < 0.001) and SSAl (p < 0.001) improved significantly. In group 2 all the parameters investigated improved but did not reach significant difference. Discussion: Our medical device with a plasma-like formulation is able to maintain prp active for a period of 7 days so patients are able to apply topically growth factors at home. Conclusions: Our prospective study proves that the use of topical prp reduces superficial perioral wrinkles and restore dermal matrix when used at home for 12 weeks.

Clinical efficacy and safety of polynucleotides highly purified technology (PN-HPT®) and cross-linked hyaluronic acid for moderate to severe nasolabial folds: A prospective, randomized, exploratory study.

INTRODUCTION: The mandibular profile undergoes progressive wasting with aging, and the deepening of nasolabial folds (NLFs) has a leading role. Hyaluronic acid (HA) efficiently controls tissue hydration and permeability to small and large molecules. NLFs are an acknowledged HA target; at the same time, another class of agents, PN-HPT® (Polynucleotides Highly Purified Technology), enjoy growing acknowledgement in aesthetic medicine. This exploratory, prospective study probed the rationale of sequentially associating PN-HPT® as a first priming agent acting in the skin followed by HA dermal filler injections for correcting moderate to severe NLFs. METHODS: Following strict inclusion and exclusion criteria, the authors screened Caucasian ambulatory women aged 40-65 with moderate to severe NLFs and randomly selected two NLFs for each enrolled woman. Due to the purely explorative nature of the study, the authors initially planned to enroll no >10 women. According to a split-face design, the selected right-side NLFs received 4 ml of PN-HPT® intradermally in the initial priming phase ("NLF Rx group"); the selected left-side NLFs received 4 ml of saline (placebo) ("NLF Lx group"). After 3 and 6 weeks, all patients received 2 ml of subdermal cross-linked HA over both NLF areas (4 ml overall). The total study follow-up was 6 months after the first injection, with objective assessments, based on the qualitative and quantitative Antera 3D® and Vectra H2® skin imaging technologies, after 6 weeks and 3 and 6 months. RESULTS: Because of the favorable early outcomes, the authors let enrollment progress between January and June 2020 up to a total of 20 women and 40 NLFs. All treated women completed the six-month follow-up without reporting side effects, even clinically minor. The Antera 3D® device demonstrated that wrinkles and skin texture significantly improved in the NLF Rx after 6 weeks (monotherapy phase) and 3 and 6 months (PN-HPT® priming + HA phase) compared with baseline. HA levels, measured with the quantitative Vectra H2® assessment technology in the right NLFs, were significantly higher than contralaterally at both 3 and 6 months. CONCLUSIONS: Although conceived only as an exploratory investigation, the study confirmed that PN-HPT® monotherapy might be a valuable and effective option to rapidly improve the skin dermis texture and quality in individuals with moderate to severe NLFs. Acting as a priming agent in the skin, PN-HPT® prolong the clinical efficacy of cross-linked HA. Well-designed trials in larger treatment groups will hopefully confirm these early promising results.

Surgical site infections after post-bariatric abdominoplasty and flank liposuction: a case-control study focusing on the quantity of tissue removed.

We evaluated whether the quantity of fat removed during abdominoplasty and liposuction correlated with the occurrence of surgical site infection (SSI). We selected patients of similar age, sex, smoking status, obesity, and post-bariatric weight loss, retrospectively, and classified them into groups according to the development of SSI. The total amount of fat removed and aspirated was compared. The size of the flap removed from the abdomen and the amount of fat aspirated with liposuction differed significantly between the SSI and no-SSI groups (1.6 ± 0.2 vs. 0.6 ± 0.3 kg and 2 ± 0.2 vs. 0.9 ± 0.3 l, respectively; p < 0.001). The four SSI patients with the most fat removed (1.4 ± 0.2 kg) or aspirated (2 ± 0.1 l kg) had the deepest infections. SSI was strongly correlated with the size of flap resection (ρ = 0.80; p < 0.001) and liposuction (ρ = 0.72; p < 0.001). The quantity of fat removed or aspirated can influence the occurrence of SSI. If confirmed, these data could be used to better stratify patients according to their risk.

Prospective randomized clinical study of a new topical formulation for face wrinkle reduction and dermal regeneration.

BACKGROUND: A new topical formulation (TF) based on 3 main lifting components has been developed to reduce superficial facial wrinkles. OBJECTIVES: Determine the effectiveness of this new TF in reducing superficial face wrinkles and restructuring the dermal matrix. METHODS: Women, aged 30-65 y.o. with moderate to severe crow's feet wrinkles were included. EXCLUSION CRITERIA: men; younger than 30 or older than 65 years old; smokers. Patients received 15 IU of botulinum toxin on crow's feet and 2 creams. Fifty patients (Group 1) applied the TP (Product A) and 50 (Group 2) a placebo (Product B). Assessments were made by digital macro-photography's, Antera 3D, and a patient satisfaction questionnaire. RESULTS: From April to June 2019, 100 women were enrolled in the study and were divided into two homogeneous groups. No major or minor side effects were reported. In group 1, wrinkles, texture, static and dynamic crow's feet wrinkles improved significantly at 3 and 6 months. Patients were very satisfied at 3 months and satisfied at 6 months. In group 2, wrinkles and texture improved significantly at 3 months but did not improve at 6 months. Static and dynamic crow's feet wrinkles improved significantly at 1 and 3 months but did not improve significantly at 6 months. CONCLUSIONS: Our prospective and randomized study has shown that the new TF is safe and effective in reducing superficial face wrinkles and producing dermal regeneration. It, therefore, prolongs the duration of the botulinum toxin. Further controlled study would be necessary to compare the new TF to neurotoxin treatment, or its action alone.

Transversus abdominis plane block reduces the analgesic requirements after abdominoplasty with flank liposuction.

INTRODUCTION: The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle. We describe results obtained with a case control study between patients undergoing abdominoplasty with the TAP block compared with a similar group of patients not receiving the block. MATERIALS AND METHODS: Medical notes were reviewed, and patients were classified according to the presence of TAP. Outcomes evaluated were the requirements of morphine in the first postoperative hour and the number of co-codamol tablets administered afterward. RESULTS: Seventy-five patients were screened. No intra- or postoperative complications were recorded. TAP+ patients required significantly less analgesia during the first 12 postoperative hours (P < 0.001). The patients with increased body mass index and large flap resected were more likely to fail the anesthetic block and required postoperative analgesia. CONCLUSIONS: In aesthetic abdominal surgery, the TAP block is safe, is performed without ultrasound guidance, and markedly reduces the requirement of postoperative opioid analgesia. Future studies will now confirm these results and evaluate the consequences in terms of postoperative nausea, vomiting, and overall satisfaction of patients.

Pseudomonas aeruginosa necrotizing infection of the abdominal flap in a post-bariatric patient undergoing body contouring surgery.

Pseudomonas aeruginosa infections may involve any organ or body district and may give serious clinical sequelae. We report the case of an infection of the abdominoplasty flap that compromised wound closure and jeopardized the aesthetic outcome. To the best of our knowledge, this is the first such case reported in the literature for this group of patients. We have presented this case in order to alert plastic and general surgeons who may encounter this complication in future, such that they may be aware of the need to adopt an aggressive approach to manage these patients. This consisted of the accurate monitoring of the patient's clinical condition, prescribing appropriate antibiotics, and performing serial debridement of necrotic tissue.

Postbariatric patients undergoing body-contouring abdominoplasty: two techniques to raise the flap and their influence on postoperative complications.

Postbariatric patients undergoing abdominoplasties were retrospectively analyzed to correlate postoperative local complications with the 2 most commonly used techniques of raising the abdominal flap: diathermocoagulation versus scalpel. All patients undergoing body-contouring abdominoplasties were included. Excluded were patients with ongoing clinical infections, those that received a complete course of antibiotic in the 6 months before operation, those requesting steroid therapy, those with systemic diseases that could impair wound repair (arteriosclerosis, diabetes mellitus), and those who had undergone apronectomy. One hundred thirty-seven patients were divided into 2 groups (diathermocoagulation = 90 vs. scalpel = 47). Overall, 7 seromas (5.1%), 7 hematomas (5.1%), and 28 wound infections (20.4%) were detected. A higher occurrence of postoperative hematomas was found after the flap raised using a scalpel (12.8% vs. 1.1%, Fisher exact test, P < 0.05), with a relative risk of 11.6. A significant association existed between postoperative hematomas and wound infections with delayed healing (n = 10, 7.3%): 43% of patients with a hematoma also experienced a wound infection with delayed healing versus 5.4% of those that did not develop hematomas (Fisher exact test; P < 0.01). In patients for whom a scalpel had been used to raise the flap, this correlation persisted (50% of patients with a hematoma had developed a wound infection with delayed healing vs. 7.3% of those that did not develop hematomas; Fisher exact test; P < 0.05).In postbariatric patients, diathermocoagulation reduces the occurrence of postoperative hematomas and wound infections with delayed healing compared with the cold knife.

Pulmonary embolism after combined abdominoplasty and flank liposuction: a correlation with the amount of fat removed.

BACKGROUND: We prospectively followed patients who underwent esthetic abdominoplasty and flank liposuction to determine the influence of the amount of fat removed on the occurrence of pulmonary embolism. MATERIALS AND METHODS: We recruited patients undergoing abdominoplasties and flank liposuction and composed 2 groups according to the amount of fat removed, one of small resections (<1500 g) and the other of great resections (>1500 g). All patients received deep vein thrombosis prophylaxis. RESULTS: Since January 2005, we enrolled 103 patients and registered 3 embolisms (2.9%). All occurred in nonsmokers, had no risk factor for deep vein thrombosis, and a resection weight greater than 1500 g (21.4%; 3/14). The calculated relative risk conferred by the amount of fat greater than 1500 g was 7.4. An association was also found with duration of surgery: all embolisms occurred in patients that underwent long operation (>140 minutes; 8.8%; 3/34) with a relative risk of 3.0. CONCLUSIONS: The amount of fat removed during plastic surgery is a factor influencing the occurrence of pulmonary embolism in patients undergoing abdominoplasty/flank liposuction, and the duration of surgery is a concomitant factor. Should this data be confirmed, specific measures for prevention of this serious complication could be developed.

Miniabdominoplasty for the treatment of aesthetic defects after Pfannenstiel incisions.

We describe the miniabdominoplasty technique adopted in patients with unfavourable aesthetic defects after Pfannenstiel incisions and give our results from 32 patients. Eligibility criteria were cutaneous ptosis after Pfannenstiel incisions, and skin elastic enough to do the miniabdominoplasty. Exclusion criteria were obese or previously fat subjects in whom the operation was not possible. The technique is based on the combination of a miniabdominoplasty done obliquely up to the fascia, and liposuction. We operated on 32 patients from September 2005 to May 2006. We saw no postoperative bleeding, haematoma, or seroma. Thirty-one patients had a good final result. In one case postoperative asymmetry required secondary remodelling, which was done under local anaesthesia as an outpatient. After six months follow-up we recorded no asymmetry or change in body shape. We use the miniabdominoplasty technique for the correction of cosmetic abnormalities after Pfannenstiel incisions. It is feasible and safe, with a short operating time, and gives good aesthetic results and few postoperative complications. Further studies, with more patients, are now required to validate these results.

Laparoscopic adjustable gastric bandings: a prospective randomized study of 400 operations performed with 2 different devices.

OBJECTIVE: To evaluate potential differences between 2 devices used to perform laparoscopic adjustable gastric bandings (the Swedish adjustable gastric band and the Lap-Band). DESIGN: The following groups were considered eligible: (1) patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of greater than 40; (2) patients with a body mass index between 35 and 40, with associated comorbidities; and (3) patients with a body mass index of greater than 60 who could not undergo derivative procedures. RESULTS: We recruited 400 patients. The mean +/- SD body mass index decreased to 40.6 +/- 3.0 after the first year and to 35.2 +/- 7.0 after 2 years. The average excess weight loss reduction was 48.2% after 1 year and 56.0% after 2 years. The excess weight loss reduction was inversely related to the initial weight: patients with an estimated weight excess of 50 kg or less (108 patients [27.0%]) had an excess weight loss reduction of 55% after 2 years; those with a weight excess of greater than 50 kg (292 patients [73.0%]) had an excess weight loss reduction of 44% (P = .004). We recorded 1 death (0.2%). Transient gastric occlusions (24 patients [6.0%]) and slippages (12 patients [3.0%]) were the most common complications. The devices used (Swedish adjustable gastric band and Lap-Band) were similar in terms of correction of obesity and morbidity. CONCLUSIONS: Laparoscopic adjustable gastric banding is a safe and feasible technique with specific indications in moderately obese patients and, secondarily, in highly obese patients who are unfit for more invasive techniques. No differences were found among the devices examined. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN22839090.

Iatrogenic collapse of the nasal valve after aesthetic rhinoplasty.

We present our experience of reconstruction of the nasal valve after iatrogenic collapse, and evaluate the feasibility and outcome of composite grafts. We selected all collapsed nasal valves that occurred after primary aesthetic rhinoplasties of the total number done at the University Tor Vergata in Rome. We excluded collapses that followed septoplasty for nasal deviation, reconstructions, and rhinoplasties for trauma. We selected 15 patients of 1252 who presented from January 1998 to December 2003. Eleven patients who had collapse of both the external and internal valve were treated with a composite graft (septum plus retroauricular) inserted by an "open tip" technique. Four patients (1 with both internal and external valve collapse, 3 with only internal) were treated with a section and opening of the upper lateral cartilages, transposition and repositioning of mucocartilaginous flaps. Good functional and aesthetic results were achieved in almost all patients without complications. Composite cartilaginous grafts are an easy and safe technique for the treatment of iatrogenic collapse of the nasal valve.

Sensitivity of the nipple-areola complex and areolar pain following aesthetic breast augmentation in a retrospective series of 1200 patients: periareolar versus submammary incision.

BACKGROUND: Different studies have investigated the anatomical and operative factors associated with alterations of nipple-areola complex sensitivity after aesthetic breast augmentation. The authors conducted a retrospective evaluation of a large series of patients to assess the risk factors that could be associated with such alterations. METHODS: Data were collected retrospectively from the personal archive of the first author from May of 2004 to September of 2010. Excluded were those that underwent operations on the breast different from augmentation (i.e., breast reductions), augmentations associated with other operations that could influence the nipple-areola complex (e.g., mastopexy, lifting of the nipple, inverted nipple, reduction of the nipple, capsulectomy), breast revisions, breast implant replacements, or monolateral or nonsymmetrical augmentations. RESULTS: The number of patients included in the study was 1222. The only factor associated with nipple-areola complex sensitivity alterations and areolar pain at 6 months was the type of skin incision used. Alterations were more present postoperatively with the periareolar than with the submammary incision (chi-square test, p=0.001). The periareolar incision increased the risk of nipple-areola complex sensitivity alterations almost threefold and the risk of areolar pain by more than threefold. CONCLUSIONS: The type of skin incision adopted for breast augmentation seems to influence the occurrence of postoperative nipple-areola complex alterations of sensitivity or areolar pain. Although this affects a small percentage of patients, it is worth mentioning so that a more lucid informed consent and agreement to the operation can be achieved. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

A comparative study of the transversus abdominis plane (TAP) block efficacy on post-bariatric vs aesthetic abdominoplasty with flank liposuction.

The transversus abdominis plane (TAP) block acts on the nerves localised in the anterior abdominal wall muscles. We evaluated the efficacy on post-bariatric (PB) patients undergoing body-contouring abdominoplasty. We retrospectively evaluated PB patients undergoing abdominoplasty with flank liposuction and compared results to a matched group of TAP aesthetic patients. Outcomes evaluated were the analgesic requirements during the early postoperative days. Fifty-one patients (PB n = 27, aesthetic n = 24) were assessed. No complications were observed. All PB patients required analgesia until the second postoperative day contrarily to most aesthetic ones. Patients with greater flap resected and higher pre-abdominoplasty BMI had greater morphine consumptions. In PB patients, the larger amount of tissues resected corresponded to a greater stimulation of pain fibres that cannot be paralleled by a concomitant increase of the local anesthetic administered. This partially invalidates TAP's efficacy on PB patients.

Capsular contractures: a systematic review.

BACKGROUND: The aim of this article was to review the current literature on capsular contractures, focusing in particular on the epidemiology, risk factors, cause, and treatment modalities, to provide the plastic surgeon with an up-to-date review of the current available evidence. METHODS: A literature search was undertaken of the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases. The search strategy was conducted using three groups of key words, with the first relating to the organ involved (breast), the second relating to the surgical procedure performed and related technical issues, and the third relating to the surgical complications. Potentially relevant articles were identified by means of the title and the abstract, and full articles were obtained and assessed in detail. RESULTS: Only a few studies have included large enough sample sizes, were conducted in a prospective manner, were adequately randomized, and achieved adequate follow-up periods to obtain a true measure of rates of capsular contraction occurrence. Recent advances in molecular biology, microbiology, immunology, and basic pathology have outlined some of the mechanisms that underlie this phenomenon. Revision surgery remains the only effective treatment option available but is limited by its high associated risk of recurrences. No adequate preventative measures exist in practice, beyond the avoidance of risk factors. CONCLUSIONS: Although a great deal of progress has been made over the past few decades, the exact nature and contribution of molecular, immunologic, and microbiological factors remain unclear. It is hoped that future studies will focus on attempting to resolve some of the issues highlighted in this review.

The evaluation of breast tissues removed during reductive mammaplasty with dual energy X-ray absorptiometry.

PURPOSE: We conducted a case-control study in which patients were evaluated with dual energy X-ray absorptiometry (DEXA) before and after breast reduction surgery, and results were correlated with the histological examination. Our goal was to confirm the DEXA as a precise technique for the measurement of breast composition, in order to propose it for the preoperative evaluation of plastic surgery patients. MATERIALS AND METHODS: We prospectively recruited all women that underwent reduction mammaplasty and excluded patients with contraindications to the operation or those that previously underwent bariatric surgery to reduce their weight. Patients were evaluated with DEXA 1 week before and after surgery. RESULTS: From February to October 2006 we recruited 25 patients. The statistical analysis found a significant reduction of weight, BMI, regional fat free mass and fat mass after the operation. The comparison between DEXA and the histological analysis produced a correlation r=0.989 (r(2)=0.978), with a predictivity of 98% and a percentage of error 8.3% (95% confidence intervals -252.6, 273.7; 95% limits of agreements of Bland and Altman -436.0, 457.1). Similar results were obtained with the analysis of fat. CONCLUSIONS: Our study demonstrated that conventional segmental DEXA is a very precise technique to measure the amount of tissue removed in breast reductions and could open future application in the preoperative assessment of patients undergoing such operations.

Wound infections in aesthetic abdominoplasties: the role of smoking.

BACKGROUND: In this prospective study, the authors followed patients who underwent aesthetic abdominoplasty to determine the influence of smoking on the occurrence of postoperative wound infections. METHODS: Patients who underwent aesthetic abdominoplasty were considered eligible for the study. The authors excluded postbariatric patients, those with ongoing clinical infections, those receiving a recent antibiotic course, and those with systemic diseases such as arteriosclerosis and diabetes mellitus. Smokers were advised to quit smoking at least 4 weeks before surgery. RESULTS: Starting in February of 2004, the authors enrolled 84 patients. Postoperative infections were present in 13 patients (15.5 percent) and were superficial in 10 (77 percent). All but one occurred in smokers. These had a certain number of cigarettes smoked per day, years of smoking, and higher estimated overall number of smoked cigarettes when postoperative infections were present. The relative risk of smoking on infections was 12. A cutoff value of approximately 33,000 overall cigarettes smoked determined 3.3 percent false-positive and 0 percent false-negative rates. CONCLUSIONS: Smoking is an important issue in aesthetic surgery that needs to be accurately addressed during the preoperative interview. In the future, the analysis of smoke-related, easy-to-gather variables such as the estimated overall number of cigarettes smoked until surgery could help stratify patients according to their risk of manifesting infections.