Data Requirement for Animal-Derived Wound Care Devices: Limitations of the 510(k) Regulatory Pathway.

BACKGROUND: Device classification and preclinical data requirements for animal-derived wound care products were recently reviewed by the FDA. Given the possible performance differences for these products, we evaluated the FDA data requirements as well as the published literature for all animal-derived wound care products ever cleared through the FDA. STUDY DESIGN: The publicly available online database was queried for all animal-derived wound products; premarket data requirements for each product were recorded. A PubMed search was conducted to determine the number of published clinical studies for each product, and manufacturer websites were accessed to obtain the price for each product. RESULTS: A total of 132 animal-derived wound products have been cleared by the FDA since the Center for Devices and Radiological Health was established in 1976. Of these, 114 had a publicly available clearance statement online. Preclinical biocompatibility testing was performed in 85 products (74.6%) and referenced in 10 (8.8%). Preclinical animal wound healing testing took place in 17 (14.9%). Only 9 products (7.9%) had clinical safety testing, and no products had clinical effectiveness data. We found no published peer-reviewed clinical data for 97 products (73%). Cost was infrequently available but ranged from $4.79 to $2,178 per unit. CONCLUSIONS: Although the current pathway is appropriate for efficiently clearing new wound care products, clinical effectiveness is not included in the regulatory review process. Wound care products are primarily evaluated by the FDA for safety and biocompatibility. Thus, any claims of clinical effectiveness require independent validation, which is often lacking.

The Versatile Role of Fat Injection During Various Genioplasties.

BACKGROUND: Fat injection has become increasingly popular in aesthetic surgery, but there is a sparsity of literature regarding its role during genioplasty. In this study, we present the largest series of patients receiving fat injections to the chin for various indications. METHODS: Data were collected from January 2016 to December 2021 for patients who underwent chin fat injection for a variety of chin refinements. Patients with chin fat injection were divided into isolated genioplasty with fat injection (CF), combined facial and chin fat injection (CFC) and combined chin fat injection and osseous genioplasty (CFG). Complication rates and reoperations were compared using Fischer's exact test between each cohort. RESULTS: 181 patients were included in final analysis, with 14 patients in CF cohort, 130 patients in CFC cohort, 24 patients in CFG cohort, and 13 patients who underwent genioplasty alone. Repeat fat injections were required in 17 (9.4%) patients overall, which included 14 patients (10.8%) of CFC subcohort and three patients (12.5%) of CFG subcohort (p > 0.05). No patients who underwent genioplasty alone or CF required reoperation. There were no significant differences in complications between genioplasty alone group (0%) in comparison to CF (7.1%; p = 1.00), CFC (6.2%; p = .53), or CFG cohorts (7.7%; p = 1.00). CONCLUSION: Fat injection can safely correct minor chin deficiency or asymmetry, as either an isolated procedure or in combination with osteotomies. Additionally, fat injection enables advancement of the caudal segment to achieve superior outcomes by preventing unaesthetic deepening of labiomental groove which will not be advanced during sliding osteotomy. LEVEL OF EVIDENCE IV: 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 .

The Logical Sequence of Primary Open Rhinoplasty Founded on the Principles of Rhinoplasty Dynamics.

Rhinoplasty is a perplexing procedure due to the variety of complex interplays between anatomical structures of the nose and the maneuvers used to accomplish the intended objective. Although every rhinoplasty is individualized, having a systematic order and an algorithm is crucial to achieve the designed aesthetic goals and a superior outcome, considering the interactions between maneuvers. Otherwise, the accumulated, unanticipated effects will result in displeasing outcomes due to over or under correction. In this report, we describe the sequential steps of rhinoplasty based on knowledge that the senior author has garnered over four decades of experience and having studied the rhinoplasty dynamics continually. Furthermore, we explain the detailed reasoning for each maneuver based on surgical indications and the resulting interplays.Level of Evidence IV 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 http://www.springer.com/00266.

Common Dorsal Flaws Following Preservation Rhinoplasty: A Systemic Analysis.

BACKGROUND: There has recently been a resurgence of interest in preservation rhinoplasty (PR) for dorsal hump elimination or dorsal projection reduction. However, no studies have scrutinized aesthetic outcomes to identify common pattern of flaws seen in published images to aid those with ardent enthusiasm for this technique to become aware of the frequency of these flaws and find ways to reduce imperfections. METHODS: A systematic literature review was performed using search terms ("preservation" OR "let down", "push down") AND "rhinoplasty" on PubMed, Cochrane, SCOPUS, and EMBASE databases for studies between January 2000 and December 2022. Patient images from these studies were analyzed by three reviewers (MWW, IAC, and BG) for dorsal flaws. Raw interrater agreement percentage and Krippendorff's alpha were calculated to determine interrater reliability. A descriptive and comparative analysis with Fisher's exact test was performed for the aggregate data. RESULTS: There were 59 patient images with 464 views from 24 studies included for final analysis. Optimal dorsal aesthetic lines (DAL) were noted in 12 patients (20.3%), while optimal profile was observed in 15 patients (25.4%) (p = 0.66). Combined ideal front and profile view of dorsum was not observed on any patients. The most common flaws were DAL irregularities (n = 45; 78.0%), dorsal deviation (n = 32, 54.2%), and residual hump (n = 25, 42.4%). There was excellent interrater agreement. CONCLUSIONS: While PR may have some advantages, it has shortcomings in outcomes, particularly dorsal irregularities, dorsal deviation, and residual humps. Awareness of these imperfections may compel those performing this procedure to modify their techniques and improve their results. LEVEL OF EVIDENCE III: 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 .

Exploring the Resurgence of the Preservation Rhinoplasty: A Systematic Literature Review.

INTRODUCTION: The underlying principles of preservation rhinoplasty (PR) center around maintaining the soft tissue envelope, dorsum, and alar cartilage through surgical manipulations and tip suture techniques. In particular, the let-down (LD) and push-down (PD) techniques have been described, although reports of indications and outcomes in the literature are sparse. METHODS: A systematic review of the literature was performed using search terms "preservation" OR "let down" OR "push down" AND "rhinoplasty" on PubMed, Cochrane, SCOPUS, and EMBASE databases. Patient demographic information, operative details, and surgical outcomes were recorded. Sub-cohorts for patients who underwent LD and PD techniques were analyzed utilizing Fischer's exact test for categorical variables and Student's t test for continuous variables. RESULTS: Overall, there were 5967 PR patients in 30 studies in the final analysis, with 307 patients in the PD cohort and 529 patients in the LD cohort. The Rhinoplasty Outcome Evaluation Questionnaire showed a significant increase of patient satisfaction after PR compared to before PR (62.13 vs 91.14; p < 0.001). There was a significantly lower rate of residual dorsal hump or recurrence of 1.3% (n = 4) in the PD when compared to 4.6% (n = 23) in LD cohorts (p = 0.02). The revision rate of PD (0%, n = 0) was also significantly lower than that of LD (5.0%, n = 25) (p < 0.001). CONCLUSION: Based on these published articles, it seems that preservation rhinoplasty is safe and efficacious procedure with improved dorsal aesthetic lines, reduced dorsal contour irregularities, and claimed excellent patient satisfaction. In particular, the PD technique has fewer reported complications and revisions than LD approach, although PD is often indicated in patients with smaller dorsal humps. LEVEL OF EVIDENCE III: 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 .

Nonpharmacologic Treatments for Chronic and Episodic Migraine: A Systematic Review and Meta-Analysis.

BACKGROUND: Minimally invasive techniques for treatment-resistant migraine have been developed on recent insights into the peripheral pathogenesis of migraines. Although there is a growing body of evidence supporting these techniques, no study has yet compared the effects of these treatments on headache frequency, severity, duration, and cost. METHODS: PubMed, Embase, and Cochrane Library databases were searched to identify randomized placebo-controlled trials that compared radiofrequency ablation, botulinum toxin type A (BT-A), nerve block, neurostimulation, or migraine surgery to placebo for preventive treatment. Data on changes from baseline to follow-up in headache frequency, severity, duration, and quality of life were analyzed. RESULTS: A total of 30 randomized controlled trials and 2680 patients were included. Compared with placebo, there was a significant decrease in headache frequency in patients with nerve block ( P = 0.04) and surgery ( P < 0.001). Headache severity decreased in all treatments. Duration of headaches was significantly reduced in the BT-A ( P < 0.001) and surgery cohorts ( P = 0.01). Quality of life improved significantly in patients with BT-A, nerve stimulator, and migraine surgery. Migraine surgery had the longest lasting effects (11.5 months) compared with nerve ablation (6 months), BT-A (3.2 months), and nerve block (11.9 days). CONCLUSIONS: Migraine surgery is a cost-effective, long-term treatment to reduce headache frequency, severity, and duration without significant risk of complication. BT-A reduces headache severity and duration, but it is short-lasting and associated with greater adverse events and lifetime cost. Although efficacious, radiofrequency ablation and implanted nerve stimulators have high risks of adverse events and explantation, whereas benefits of nerve blocks are short in duration.

Frequency, Indications and Intraoperative Dynamics of Repositioning of the Lateral Crura of the Lower Lateral Cartilage: A 35-Year Experience.

BACKGROUND: Lower lateral cartilage repositioning (LLCR) is an effective technique that places the lateral crus in a newly created caudal pocket, and is utilized for a variety of indications including cephalic malposition, alar asymmetries and tip rotation/projection alteration. However, there is a relative sparsity in the literature regarding this procedure and the dynamic changes that it produces. In this study, we report our experience with LLCR in regard to its indications and related interplays. METHODS: Data from our institution were collected from the most recent 100 primary rhinoplasties, most recent 100 secondary rhinoplasties and all LLCRs performed. For each LLCR, patient demographics and concurrent surgical techniques were compiled. A descriptive analysis was performed for all cohorts, while Fischer's exact test was performed to compare the associations of categorical data for the respective sample sizes of the primary and secondary rhinoplasty cohorts. RESULTS: Overall, 127 patients underwent LLCR, with eleven (11%) LLCRs in the primary rhinoplasty cohort and twelve (12%) LLCRs in the secondary rhinoplasty cohort. The most common indication for LLCR was cephalic malposition, followed by over-projection and asymmetry of the lower lateral cartilages. Intraoperative observation of dynamic changes included invariable cephalic rotation of the tip, ability to precisely control the tip projection, drastic narrowing of the domal arch often minimizing the need for the transdomal suture, alar repositioning caudally, correction of alar retraction and more elegant tip definition. However, the external valve lost its strength on majority of LLCR patients, which required almost routine use of Gunter lateral crus strut. CONCLUSION: LLCR is a powerful and versatile tool that can be utilized in either primary or secondary rhinoplasty. Its transposition results in cephalic rotation of the tip, narrowing of the domal arch, caudal reposition of the alar rim and superior tip definition. LEVEL OF EVIDENCE IV: 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.

Postsurgical Outcomes with Meshes for Two-stage Prosthetic Breast Reconstruction in 20,817 Patients.

Use of acellular dermal matrices (ADMs) for tissue expander breast reconstruction remains controversial with an uncertain safety and efficacy profile. This study analyzes the rates and factors for reoperation and postoperative infection in patients who underwent tissue expander breast reconstruction with and without ADM. Methods: Patients who underwent breast reconstruction with and without ADM were identified from the National Surgical Quality Improvement Program database utilizing CPT codes. Covariates included patient demographics, preoperative comorbidities, and operative characteristics, while outcomes of interest were postoperative infection and reoperation. Univariate and multivariate analyses were performed to identify predictors of adverse outcomes. Results: There were 8334 patients in the ADM cohort and 12,451 patients who underwent tissue expander breast reconstruction without ADM. There were significantly fewer reoperations in the non-ADM cohort (5.4%) compared to the ADM cohort (7.7%) (P < 0.0001), with infection and hematoma as the most common etiologies in both cohorts. Surgical infections were also more prevalent in the ADM cohort (4.7%) compared with the non-ADM cohort (3.6%) (P < 0.0001). Univariate and multivariate analysis of the tissue expander breast reconstruction cohort revealed race, obesity, hypertension, smoking status, albumin, and operative time as predictive for infection risk, while race, obesity, hypertension, smoking, albumin, operative time, and age were significant for reoperation. Conclusion: Our study of 20,817 patients revealed significantly higher risk of infection and reoperation in patients who underwent breast reconstruction utilizing ADM versus without ADM. Patients considering ADM for breast reconstruction should engage in discussion with their surgeon about complications, aesthetics, and cost.

Maxillary and Mandibular Healing After Facial Allotransplantation.

INTRODUCTION: Facial transplantation has emerged as a viable option in treating devastating facial injuries.Despite the high healing rate of Le Fort III and bilateral sagittal split osteotomies (BSSO) in nontransplant patients, few studies have reported assessment of maxillary and mandibular healing in face transplant patients compared with nontransplant patients. The aim of this study was to examine differences in bone healing in our patients. PATIENTS AND METHODS: A retrospective chart review was conducted of facial allotransplantation patients at the Cleveland Clinic from December 2008 to inception. Demographics such as age, date of birth, and sex were recorded. Additional variables included procedures, revisions, reoperations, medications, and bone stability and healing. Computed tomography (CT) images assessed the alignment of skeletal components, bony union quality, and stability of fixation. RESULTS: Three patients were included: 2 had Le Fort III segment transplantation, and 1 had transplantation of both a Le Fort III segment and mandibular BSSO. The Le Fort III segment in all patients exhibited mobility and fibrous union at the Le Fort III osteotomy on CT. In contrast, the BSSO healed uneventfully after transplantation and revision surgery, with bony union confirmed by both CT and histology of the fixation area between the donor and recipient mandible bilaterally. No patients with midfacial fibrous union required revision of the nonunion as they were clinically asymptomatic. CONCLUSION: Le Fort osteotomy demonstrates inferior healing in facial transplantation compared with the nontransplant population. In contrast, the successful healing in the mandible is likely owing to the high density of rich cancellous bone.

Dual Fluorescent Tracers for Surgical Guidance: Preventing Donor-site Lymphedema in Vascularized Lymph Node Transfer.

Introduction: Vascularized lymph node transfer (VLNT) restores physiological lymphatic function. Although effective, postoperative impairment of donor-site lymphatic function and iatrogenic lymphedema following lymph node transfer remains a pressing concern. Methods: Prospective analysis of VLNT patients undergoing dual fluorescent tracers-assisted harvest was performed at our institution from September 2013 to April 2022. Reverse lymphatic mapping of the lower extremity was performed with indocyanine green (ICG). Blue dye was utilized in both white light and near-infrared spectra for visualization of donor-site lymphatic structures. Demographics, intraoperative details, and surgical outcomes were recorded. Results: Twenty-five patients were included. Median age was 52.9 years with a body mass index of 29.1 kg/m2 and mean follow-up of 44 months (range 24 to 90 months). Lymphedema stage ranged from Campisi 2 to 4. Inguinal VLNT was performed in 13 patients, and 12 patients received combined VLNT and free flap breast reconstruction. No patients required change in lymph node donor site intraoperatively. All ICG stained nodes were preserved in situ. No cases of iatrogenic lower extremity lymphedema were observed. Postoperative bioimpedance spectroscopy, circumferential, and volumetric measurements of the donor-site limb did not show evidence of subclinical or clinical lymphedema. The donor site healed appropriately in 92% of patients; one patient developed methylene blue-induced skin necrosis. Conclusion: Reverse lymphatic mapping and surgical guidance with dual ICG and blue dye fluorescent tracers provides surgeons with real-time surgical guidance without radioisotope, improves surgical visualization in both white light and near-infrared spectra, and avoids iatrogenic lymphatic dysfunction in the donor limb.

The Hairline Brow Lift.

Effective rejuvenation of the upper face results when effective brow repositioning is combined with maintenance or improvement of brow shape. Endoscopic brow lift techniques have increased in popularity as surgeons have investigated less invasive surgical procedures. This article provides a comparison of hairline brow lift with other open and endoscopic techniques used for improving brow position. It includes a detailed description of hairline brow lift with videos illustrating the authors' preferred technique. It also provides a description of ideal candidates including indications and contraindications to procedure, and common modifications to technique used in select patient populations.

The Positive Patient Experience: A Comprehensive Analysis of Plastic Surgery Online Reviews.

BACKGROUND: Subjective online physician evaluation is an important component of patient decision-making. Understanding reviews may improve satisfaction and build positive online reputation. OBJECTIVES: The aim of this study was to analyze and compare the top predictive factors driving patient satisfaction across the most popular plastic surgery procedures. METHODS: Online reviews were analyzed from RealSelf, Yelp, and Google for the 5 highest-rated plastic surgeons in 6 US metropolitan areas. Blank, non-English, consultation, duplicate, and unrelated reviews were excluded. Data from free-text reviews included physician rating, patient-reported reasons for rating, procedure, and complications. Univariate analysis was performed to compare predictive factors of online ratings. RESULTS: In total, 11,078 reviews were included. RealSelf had the highest average rating (4.77), and Yelp had the lowest (4.66). Reviews in Miami, Philadelphia, New York City, and Chicago were mostly published on RealSelf, whereas Houston and Los Angeles mostly used Google and Yelp, respectively. Reconstructive procedures were rated significantly higher than cosmetic procedures (P = 0.035). Aesthetic appearance was the strongest predictor of rating across all procedures. Buccal fat removal (98.8%) and abdominoplasty (98.1%) had the highest satisfaction, and Brazilian butt lift had the lowest (88.2%) (P < 0.001). Additional significant contributors included staff interaction, bedside manner, health outcomes, complications, and postoperative care (P < 0.001). CONCLUSIONS: Although aesthetic outcome is an important predictor of satisfaction, other aspects of care, such as bedside manner and staff interaction, provide an important foundation of support. Excellent patient-surgeon communication and postoperative care may mitigate patient dissatisfaction and elicit high-satisfaction online patient reviews.

Labiaplasty: Analysis of the National Surgical Quality Improvement Program Database.

BACKGROUND: Labiaplasty is an increasingly popular procedure performed for both cosmetic and pathologic etiologies. Questions have been raised regarding the efficacy of the procedure, especially for cosmetic etiologies. OBJECTIVES: The aim of this study was to examine the complication profiles of labiaplasties for both cosmetic and pathologic etiologies. METHODS: The 2005 to 2017 National Surgical Quality Improvement Program database was analyzed for patients who, according to the relevant Current Procedural Terminology code, had undergone labiaplasties. Our cohort was further separated into cosmetic and pathologic groups based on International Classification of Diseases codes. Information was collected on patient demographic characteristics, patient comorbidities, and operative variables. Outcomes of interest included surgical complications and delayed length of stay (DLOS). A univariate analysis and multivariate logistic regression were applied to determine statistically significant predictors of our outcomes of interest for both etiologies. RESULTS: There were 640 patients in the cosmetic cohort and 1919 patients in the pathologic cohort. There were no significant differences in rates of surgical complications between the 2 groups, but there was a statistically significant increase in length of stay for the pathologic group. Univariate analysis revealed operative time and plastic surgeon specialty to be predictive of DLOS in the cosmetic cohort. No covariates were implicated with multivariate analysis for either surgical complications or for DLOS in the cosmetic cohort. CONCLUSIONS: Our findings suggest that cosmetic labiaplasty is a safe and efficacious procedure with low complication rates and no predictors of adverse outcomes.

A Multimetric Readability Analysis of Online Patient Educational Materials for Submental Fat Reduction.

BACKGROUND: Patients often utilize the Internet to seek information related to their care. This study assesses the readability of online patient educational materials for submental fat reduction. METHODS: Patient educational materials from the 12 most popular websites related to submental fat reduction were downloaded and assessed for readability grade level using 10 unique scales. RESULTS: Analysis of the 12 most popular websites (and corresponding 47 articles) revealed that patient educational materials were written, on average, at an 11th grade reading level. The Flesch Reading Ease score was 48.9 (range 39.8-59.2), representing a "difficult" level of reading. Mean readability grade levels (range 9-13th grade for individual websites) were as follows: Coleman-Liau, 11.1; Flesch-Kincaid, 10.8; FORCAST, 10.8; Fry Graph, 10.1; Gunning Fog, 12.7; New Dale-Chall, 10.1; New Fog Count, 11.8; Simple Measure of Gobbledygook, 11.7; Raygor, 6.7. No website was at the 6th grade reading level for patient educational materials recommended by the American Medical Association and National Institutes of Health. CONCLUSIONS: Online patient educational materials for submental fat reduction are written well above the recommended reading level. Recognition of disparities in health literacy is necessary to enable patients to make informed decisions and become active participants in their own care. 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.

Repair Sequence and Management of the Premaxilla in Patients With Bilateral Cleft Lip and Palate: A Systematic Review of the Literature.

BACKGROUND: Bilateral cleft lip and palate (BCLP) remains a difficult surgical problem due to the severely protruding premaxillary segment, with no consensus of optimal treatment sequence in older patients. A systematic review of the literature was performed to assess the current status of BCLP repair based on age. METHODS: A PRISMA systematic review of the PubMed, Web of Science, and Embase databases was performed using a series of search terms related to BCLP. Studies were categorized based on the age of presentation, repair sequence, and technique. RESULTS: The database search identified 381 articles. Of these, 72 manuscripts were ultimately included. The lip was repaired first in 1077 patients (86.0%), palate first in 161 patients (12.9%), and simultaneous lip and palate in 14 patients (1.1%). Patients less than 6 months old received lip repair first (n = 959, 98.6%), with complications of unaesthetic appearance (n = 86, 62.3%) and midface retrusion (n = 41, 34.1%) in younger patients and wound dehiscence (n = 8, 40%) in older patients. Primary lip repair was preceded by presurgical orthopedics (n = 760) or lip adhesion (n = 272) to reduce lip tension with nasoalveolar molding (n = 452, 62.9%) or the Latham device (n = 282, 37.1%). In older patients, the palate was repaired first or premaxillary setback (n = 222) was indicated in protruded premaxillae greater than 10 mm, but carried the risk of premaxilla mobility (n = 20, 37.7%) and midface retrusion (n = 10, 18.9%). CONCLUSION: In younger patients, lip repair is performed first with preoperative orthopedics or lip adhesion. In older patients, the palate is more commonly repaired first compared with the lip; however, there is no difference in complication rate.