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.

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.

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.

Sedation with local versus general anesthesia for the tension-free vaginal tape Secur hammock procedure.

OBJECTIVE: To compare the intraoperative and immediate postoperative results achieved with the tension-free vaginal tape Secur (TVT-S) hammock procedure performed under local anesthesia (LA) versus general anesthesia (GA). METHODS: Prospective randomized trial involving patients with symptomatic stress urinary incontinence grades 1 or 2 who underwent TVT-S under either LA or GA. Postoperative pain intensity, duration of hospitalization, rate of complications, duration of operating and recovery times, and number of additional procedures required were recorded. RESULTS: Each group included 40 patients. The operative times were identical in the 2 groups, but the time spent in the recovery room was significantly longer in the GA group. Patients undergoing LA experienced less pain than did those undergoing GA. Most patients in the LA group had day surgery, whereas most patients in the GA group went home 1day after the surgery. No significant differences were observed for the rates of complications. CONCLUSION: Performing the TVT-S hammock technique under LA rather than GA reduces postoperative pain and shortens the duration of hospitalization.

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.

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.

Epidemiological aspects of urinary incontinence in a female population of an Italian region.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to assess the incidence of female urinary incontinence (UI), risk factors, severity, and functional limitation using a cross-sectional survey in an Italian region. METHODS: The method employed in this study was a questionnaire-based interview on non-institutionalized women. Outcomes were the UI prevalence, severity, associated factors, and functional limitation (ICIQ score). RESULTS: From October 2008 to February 2009, 1,346 women were interviewed and 15.3% were affected by UI. Univariate analysis found different risk factors, but multivariate analysis revealed only pelvic floor surgery, diabetes, vaginal deliveries, age, and educational level as significant. The involuntary loss of stools was more common in incontinent patients compared with healthy participants. The ICIQ values were significantly different between healthy and incontinent participants and a positive correlation existed with the estimated daily urine loss (r = 0.885, p < 0.001). CONCLUSIONS: Symptoms of UI affected a substantial proportion of the population investigated. Pelvic floor surgery, diabetes, and vaginal deliveries are the most significant risk factors implicated.

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.

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.

The influence of BMI, smoking, and age on vaginal erosions after synthetic mesh repair of pelvic organ prolapses. A multicenter study.

OBJECTIVE: To study the influence of body mass index (BMI), smoking, and age on the risk of vaginal erosions after mesh repair of pelvic prolapses. DESIGN: Retrospective study. SETTING: Three university and community hospitals. POPULATION AND SAMPLE: Patients that underwent mesh correction of prolapses between 2002 and 2007. Excluded were those with stress urinary incontinence, ongoing clinical infections, with a complete antibiotic course in the last six months and with systemic diseases affecting tissue oxygenation. METHODS: Revision of medical notes. MAIN OUTCOME MEASURES: Risk contributions for age, smoking, and BMI on the occurrence of vaginal erosions. RESULTS: Data were collected from 460 patients. Postoperative erosions were present in 7%. BMI greater than 30 conferred a 10.1-fold increase in the risk of developing erosions, smoking a 3.7-fold increase, and age greater than 60 years a 2.2-fold increase. A cut-off value of seven pack years was determined for smoking where the risk associated with light smokers was similar to that of non-smokers. CONCLUSIONS: BMI, smoking, and age are important risk factors for pelvic organ prolapse surgery. Our data could be used to stratify patients according to their risk so that preventative measures can be taken in high-risk 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.

Bladder erosion after 2 years from cystocele repair with type I polypropylene mesh.

Type I polypropylene mesh have been widely used in gynaecologic surgery for the treatment of pelvic organ prolapse and stress urinary incontinence. Such devices produced positive results compared to the equivalent non-mesh-based operation but erosions into adjacent viscera, especially the vagina, have also been reported. We describe the case of bladder erosion that manifested two years after the initial cystocele repair surgery and the management adopted.

Transvaginal cystocele correction: Midterm results with a transobturator tension-free technique using a combined bovine pericardium/polypropylene mesh.

AIMS: To describe the benefits and complications of a combined bovine/pericardium polypropylene mesh for severe vaginal wall prolapse at midterm follow up. METHODS: Retrospective analysis of patients with stages 3 and 4 pelvic prolapse undergoing cystocele repair using the combined mesh. RESULTS: Between June 2004 and April 2006 36 patients were treated. The median follow up was 35 months. Two patients experienced de novo urgency (5.6%). Resolution of prolapse was achieved in 91.7% of patients. Ten percent of those with urinary incontinence continued to suffer from incontinence after surgery. There was a significant improvement in the quality of life in cases with associated urinary incontinence, and in the sexual lives and constipation of all patients. Two cases of vaginal perforation (5.6%) and three cases of vaginal erosion (8.3%) were described. CONCLUSIONS: The use of a composite bovine pericardium/polypropylene mesh for cystocele correction is feasible and safe, yielding good results at midterm follow up.

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.

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.

Risk evaluation of smoking and age on the occurrence of postoperative erosions after transvaginal mesh repair for pelvic organ prolapses.

This study evaluated the influence of age and smoking on the occurrence of vaginal erosions after transvaginal mesh repair of pelvic organ prolapses. We recruited all patients that underwent mesh correction of prolapses and excluded those with stress urinary incontinence, ongoing clinical infections, with a complete antibiotic course in the last 6 months, and with systemic diseases affecting tissue oxygenation. We enrolled 325 patients. Postoperative erosions were present in 6%. Age conferred a 1.6-fold increase in the risk to develop erosions while smoking a threefold increase. Patients with deep erosions had the highest values of pack years, and 6.85 pack years conferred a risk similar to advanced age. Age and smoking are important factors also after pelvic organ prolapse surgery. Our data could be used to stratify patients according to their estimated risk and to dedicate them to specific cares for prevention.