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Laboratory for Materials Strength Testing (LMST) has been conducting accredited mechanical research for aviation from 2003. Among accredited procedures are e.g. low and high cycle fatigue tests, fracture toughness tests and fatigue crack growth rate tests. The main goal of them is obtaining materials constants and characteristics. However knowledge how to conduct these tests could be used also in other applications, for instance in the work on development of Structural Health Monitoring systems (SHM). When cracks propagate in a controlled way in laboratory conditions, it allows verifying the operation of a single sensor or a network of sensors.

The objective of the research presented in this paper was to determine the honeycomb core compliance of a sandwich structure of the horizontal stabilizer of the MiG-29 fighter jet in the static compression test. The study of the specimen was conducted based on the ASTM C365/C365M standard. The article presents the results of experimentally determined dependencies and strength parameters, i.e. the force-displacement dependence, the compressive modulus and the honeycomb core deformations.

In this work, the compressive residual strength tests results, Compression After Impact (CAI), are presented. The specimens were made of carbon-epoxy prepreg E722-02 UHS 130-14. Two variants of specimens were tested: samples undamaged and samples with damage that was centrally introduced by a drop-weight impact, as per the ASTM D7136/7136M standard. An impactor with potential energy equal to 15J and the type of support required by the standard were used. The size of impacted damages, defined as an area of damage on a plane perpendicular to the impact direction, and the equivalent diameter were specified using the flash thermography method.

Seat cushion inserts in military helicopters crew seats, as suggested by the helicopters manufacturers, are made of traditional polyurethane foams.

The Pitanguy ligament is a crucial structure in nasal tip support and in maintaining the integrity of the soft tissue envelope of the nose. In this cadaveric study, we dissected out the Pitanguy ligament on a series of fresh human cadaver specimens to better elucidate the structure of the ligament and its fate in open rhinoplasty. The Pitanguy ligament can act as a tethering force to the nasal tip when reshaping the nasal tip. Release of the Pitanguy ligament alleviated downward tension on the nasal tip, and tip shaping to a more appropriate position demonstrated that this ligament was displaced from its ideal position. In patients seeking rhinoplasty, this structure may require release and reconstruction to successfully alter tip position and avoid supratip deformity., (Copyright © 2024 by the American Society of Plastic Surgeons.)

On-surface polymerization of functional organic molecules has been recently recognized as a promising route to persistent low-dimensional structures with tailorable properties. In this contribution, using the coarse-grained Monte Carlo simulation method, we study the initial stage of the Ullmann coupling of doubly halogenated chrysene isomers adsorbed on a catalytically active (111) crystalline surface. To that end, we focus on the formation of labile metal-organic precursor structures preceding the covalent bonding of chrysene monomers. Four monomeric chrysene units with differently distributed halogen substituents were probed in the simulations, and the resulting precursor structures were compared and quantified. Moreover, the effect of (pro)chirality of chrysene tectons on the structure formation was elucidated by running separate simulations in enantiopure and racemic systems. The calculations showed that suitable manipulation of the halogen substitution pattern allows for the creation of diverse precursor architectures, ranging from straight and winded chains to cyclic oligomers with enantiopure, racemic, and nonracemic composition. The obtained findings can be helpful in developing synthetic strategies for covalent polymers with predefined architecture and functionality.

Summary: Alar base surgery is approached with hesitancy and is often avoided by many surgeons because of inexperience and a lack of understanding. However, with a thorough knowledge of the anatomy and dynamic nature of the lower third of the nose, alar base resection can achieve favorable and reproducible results. Beyond correcting alar flare, an appropriately diagnosed and performed alar base procedure serves to contour both the alar rim and the alar base. The following article presents a case series of 436 consecutive rhinoplasties from a single surgeon, 214 of which underwent alar base surgery. The outcomes demonstrate that the procedure is safe and yields desirable results without a single revision being required. As the third in a series of three articles on alar base surgery by the senior author (R.J.R.), this article unifies the management of the alar base. An intuitive approach to the classification and management of alar flare and the implications of alar base surgery on contouring of the alar base and alar rim is presented., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Materials with disordered structures may exhibit interesting properties. Metal-organic frameworks (MOFs) are a class of hybrid materials composed of metal nodes and coordinating organic linkers. Recently, there has been growing interest in MOFs with structural disorder and the investigations of amorphous structures on surfaces. Herein, we demonstrate a bottom-up method to construct disordered molecular networks on metal surfaces by selecting two organic molecule linkers with the same symmetry but different sizes for preparing two-component samples with different stoichiometric ratios. The amorphous networks are directly imaged by scanning tunneling microscopy under ultrahigh vacuum with a submolecular resolution, allowing us to quantify its degree of disorder and other structural properties. Furthermore, we resort to molecular dynamics simulations to understand the formation of the amorphous metal-organic networks. The results may advance our understanding of the mechanism of formation of monolayer molecular networks with structural disorders, facilitating the design and exploration of amorphous MOF materials with intriguing properties.

Autografting with split-thickness skin grafts (STSG) remains an essential procedure in burn and reconstructive surgery. The process of harvesting STSG, however, leaves behind a donor site, an exposed area of partial-thickness dermis left to heal by secondary intention. There has yet to be a consensus amongst surgeons regarding optimal management of the donor site. The ideal donor site dressing is one that allows for expeditious healing while minimizing pain and infection. Despite numerous studies demonstrating the superiority of moist wound healing, many surgeons continue to treat STSG donor sites dry, with petroleum-based gauze. In this study, two burn centers performed a retrospective review of burn patients whose STSG donor sites were treated with either Xeroform ® or Mepilex ® Ag dressings. Infections were documented and in a subgroup analysis of patients, postoperative pain scores were noted and total opiate usage during hospitalization was calculated. Analysis revealed an overall infection rate of 1.2% in the Mepilex ® Ag group and 11.4% in the Xeroform ® group (p<0.0001). Patients with Xeroform ® donor site dressings had increased odds of donor site infection (OR=10.8, p=0.002). In subgroup analysis, there were no significant differences in maximum pain scores between Mepilex ® Ag and Xeroform ® groups, nor were there differences in opiate usage. STSG donor sites dressed with silver foam dressings have a lower rate of donor site infection relative to those dressed with petroleum-based gauze. Moist donor site dressings such as foam dressings (including Mepilex ® Ag) should be the standard of care in STSG donor site wound care., (© 2023 Euro-Mediterranean Council for Burns and Fire Disasters.)

The diversity of surface-confined metal-organic precursor structures, which recently have been observed experimentally, poses a question of how the individual properties of a molecular building block determine those of the resulting superstructure. To answer this question, we use the Monte Carlo simulation technique to model the self-assembly of metal-organic precursors that precede the covalent polymerization of halogenated PAH isomers. For this purpose, a few representative examples of low-dimensional constructs were studied, and their basic structural features were quantified using such descriptors as the orientational order parameter, radial distribution function, and one- and two-dimensional structure factors. The obtained results demonstrated that the morphology of the precursor (and thus the subsequent polymer) could be effectively tuned by a suitable choice of molecular parameters, including size, shape, and intramolecular distribution of halogen substituents. Moreover, our theoretical investigations showed the effect of the main structural features of the precursors on the related indirect characteristics of these constructs. The results reported herein can be helpful in the custom designing and characterization of low-dimensional polymers with adjustable properties.

Surface-assisted fabrication of molecular network architectures has been a promising route to low-dimensional materials with unique physicochemical properties and functionalities. One versatile way in this field is the Ullmann coupling reaction of halogenated organic monomers on catalytically active metallic surfaces. In this work, using the coarse-grained Monte Carlo simulations, we studied the on-surface self-assembly of metal-organic precursors preceding the covalent Ullman-type linkage of tetrahalogenated anthracene building blocks. To that end, a series of positional isomers was examined and classified with respect to their ability of creation of extended network structures. Our simulations focused on the identification of basic types of self-assembly scenarios distinguishing enantiopure and racemic systems and producing periodic and aperiodic networks. The calculations carried out for selected tectons demonstrated wide possibilities of controlling porosity (e. g. pore size, shape, periodicity, chirality, heterogeneity) of the networks by suitable functionalization of the monomeric unit. The findings reported herein can be helpful in rational designing of 2D polymeric networks with predefined structures and properties., (© 2022 Wiley-VCH GmbH.)

Background: The opioid epidemic continues to worsen in the USA. Post-operative opioid prescriptions contribute to development of opioid use disorders, with studies showing 6% of plastic surgery patients developing new persistent use. Prescribing by surgeons is often excessive, and plastic surgery patients only consume about half of their opioid prescriptions. To date, most studies that investigate post-operative opioid prescribing rely on examining patterns of opioid fills after surgery using administrative claims data, which exclude the overwhelming majority of aesthetic surgeries. The purpose of this study is to investigate opioid prescribing habits amongst aesthetic plastic surgeons., Methods: A 20-items survey were sent out to the Aesthetic Society. The survey focussed on general pain management techniques, as well as specific opioid prescribing patterns for several common aesthetic surgeries., Results: A total of 291 completed surveys were returned. Respondents were asked about opioid prescribing patterns for several common aesthetic surgeries. Surgeons were most likely to prescribe opioids for post-operative pain control for abdominoplasty (91%). Opioids were least likely to be prescribed for blepharoplasty (58%). For studied surgeries, the number of pills prescribed ranged from 2 to 120 pills per procedure. 45% of respondents reported being concerned that the opioid prescriptions they provide contribute to the development of an opioid use disorder., Conclusions: Aesthetic plastic surgeons vary widely in their opioid prescribing. Additionally, a significant number are concerned that prescriptions they provide contribute to development of opioid use disorders. This study demonstrates the need to work towards optimizing and standardizing pain management techniques in aesthetic patients., 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 ., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)

This paper presents the results of investigations of the effect of graphene oxide and surface shot peening on the mechanical properties and fatigue life of bolts made of austenitic 304 steel. An innovative method for the uniform deposition of graphene oxide on screws is presented. The process involved activating the surface using plasma and then performing graphene oxide deposition using centrifugal force and vacuum drying. The screw specimens prepared in this way were subjected to a surface peening process. Comparative studies have shown that the combination of graphene oxide deposition and shot peening processes results in an increase in fatigue life of approximately 42 ÷ 275% (depending on the stress amplitude level) compared to the as-delivered samples. The results presented are promising and may provide a basis for further research on the application of graphene and its derivatives to increase fatigue life and improve the mechanical properties of machine components.

Background: With continuous innovation in plastic surgery, new procedures are constantly being introduced. A number of these procedures are generally safe but have the potential for rare yet serious complications. Many surgeons steer clear of these procedures due to safety concerns., Objectives: The aim of this paper was to survey the membership of The Aesthetic Society to elicit perception of risk of several novel or less mainstream procedures., Methods: A 24-item survey was sent out to members of The Aesthetic Society. The survey focused on surgeon experience and attitude towards 3 procedures: filler rhinoplasty, gluteal augmentation with fat grafting, and submandibular gland excision., Results: In total, 189 completed surveys were returned. Of the responders, 50%, 49%, and 89% of surgeons said they do not perform filler rhinoplasty, gluteal augmentation with fat grafting, or submandibular gland excision in their practices, respectively. The majority of those who do not perform the procedures selected "danger to the patient" as the primary concern for each of the 3 procedures. Surgeons overwhelmingly reported not learning these procedures in training. Additionally, surgeons perceive the risks of more common procedures such as abdominoplasty and breast augmentation-mastopexy to be significantly lower and more acceptable than those of the studied procedures., Conclusions: When comparing the perceived complication rates with data published in the literature, particularly when looking at rates of serious or life-threatening complications, plastic surgeons overestimate the risks of procedures with which they are less familiar. This perception of risk, accompanied by the lack of exposure to novel techniques in training, may contribute to surgeons avoiding these procedures., (© 2021 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Organic synthesis reactions in the adsorbed phase have been recently an intensively studied topic in heterogeneous catalysis and material engineering. One of such processes is the Ullmann coupling in which halogenated organic monomers are transformed into covalently bonded polymeric structures. In this work, we use the lattice Monte Carlo simulation method to study the on-surface self-assembly of organometallic precursor architectures comprising tetrasubstituted naphthalene building blocks with differently distributed halogen atoms. In the coarse grained approach adopted herein the molecules and metal atoms were modeled by discrete segments, two connected and one, respectively, placed on a triangular lattice representing a (111) metallic surface. Our simulations focused on the influence of the intramolecular distribution of the substituents on the morphology of the resulting superstructures. Special attention was paid to the molecules that create porous networks characterized by long-range order. Moreover, the structural analysis of the assemblies comprising prochiral building blocks was made by running simulations for the corresponding enantiopure and racemic adsorbed systems. The obtained results demonstrated the possibility of directing the on-surface self-assembly towards networks with controllable pore shape and size. These findings can be helpful in designing covalently bonded 2D superstructures with predefined architecture and functions.

Heterotopic ossification (HO) is a diverse pathologic process, defined as the formation of extraskeletal bone in muscle and soft tissues. HO can be conceptualized as a tissue repair process gone awry and is a common complication of trauma and surgery. This comprehensive review seeks to synthesize the clinical, pathoetiologic, and basic biologic features of HO, including nongenetic and genetic forms. First, the clinical features, radiographic appearance, histopathologic diagnosis, and current methods of treatment are discussed. Next, current concepts regarding the mechanistic bases for HO are discussed, including the putative cell types responsible for HO formation, the inflammatory milieu and other prerequisite "niche" factors for HO initiation and propagation, and currently available animal models for the study of HO of this common and potentially devastating condition. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

Background: The inferior lumbar triangle of Petit is bounded by the iliac crest, lateral border of the latissimus dorsi and the medial border of the external oblique., Objectives: In the present study, we aimed to quantitatively examine the base, sides, area, and interior angles of the inferior lumbar triangle in the human fetus so as to provide their growth dynamics., Material and Methods: Using anatomical dissection, digital image analysis (NIS-Elements AR 3.0), and statistics (Student's t-test, regression analysis), we measured the base, 2 sides, area and interior angles of Petit's triangle in 35 fetuses of both sexes (16 male, 19 female) aged 14-24 weeks., Results: Neither sex nor laterality differences were found. All the parameters studied increased commensurately with age. The linear functions were computed as follows: y = -0.427 + 0.302 × age for base, y = 1.386 + 0.278 × age for medial side, y = 0.871 + 0.323 × age for lateral side, and y = -13.230 + 1.590 × age for area of the Petit triangle., Conclusions: In terms of geometry, Petit triangle reveals neither male-female nor right-left differences. An increase in both lengths and area of the inferior lumbar triangle follows proportionately. The Petit triangle is an acute one in the human fetus.

Background: Recent research into adipose-derived stem cells (ASCs) suggests that anatomical location has a major impact on the metabolic profile and differentiation capacity of ASCs. By having a better understanding of how various ASCs respond to cellular stressors such as hypoxia, which are induced during routine surgical procedures, we can facilitate future development of cell-based therapies to improve wound healing., Patients and Methods: Human ASCs were isolated from the superficial and deep adipose layers of four patients undergoing elective abdominoplasty. ASCs were cultured in hypoxic (1% O2, 5% CO2, and 94% N2) conditions. After 12 and 48 hours, ASCs were assessed for markers of angiogenesis by mRNA levels of vascular endothelial growth factor A (VEGF-A), vascular endothelial growth factor B (VEGF-B), and hypoxia inducible factor 1 α (HIF-1α). Western blot analysis was performed to assess levels of VEGF-A, p-NF-κB, and NF-κB. In addition, in vitro analysis of angiogenesis was performed using Matrigel assay (BD Biosciences, Franklin Lakes, NJ)., Results: We observed significant increases in deep ASC's VEGF-A, VEGF-B, and HIF-1α mRNA expression compared with the superficial layer after 24-hour hypoxia (p < 0.05). Similar results were found when examining protein expression levels, with the deep ASCs expressing significantly larger amounts of VEGF-A and p-NF-κB (p < 0.05) compared with the superficial layer., Conclusion: Our results suggest that significant variations exist in the angiogenic profile of superficial and deep ASCs. We demonstrate that superficial ASCs are less prone to transcribe potent chemokines for angiogenesis, such as VEGF-A, VEGF-B, and HIF-1α and are less likely to translate VEGF-A and NF-κB. This may help with the selection of specific stem cell donor sites in future models for stem cell therapy., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Background: The component separation technique (CST) is an important technique now used frequently in complex ventral hernia repair (VHR). Although this technique has demonstrated superior success rates, there is a paucity of research describing how release of the external obliques coupled with rectus myofascial advancement alters the morphology of the abdominal architecture. In this study, we apply the new concept of analytic morphomics to describe the immediate changes in morphology of the abdomen that take place after VHR by CST., Methods: We identified 21 patients who underwent VHR by CST and received both preoperative and postoperative computed tomography scans between 2004 and 2009 in our clinical database. The surgical technique involved incisional release of the external oblique muscle lateral to the linea semilunaris with rectus abdominis myofascial advancement in all patients. Using semiautomated morphomic analysis, we measured the pre- and post-operative dimensions of the abdominal wall including the anterior-posterior distance from the anterior vertebra-to-skin and fascia along with the circumferential area of the skin and fascial compartments. Paired Student t-tests were used to compare pre- and post-operative values., Results: After hernia repair, there was a decrease in the anterior vertebra-to-skin distance (16.6 cm-15.8 cm, P = 0.007). There were also decreases in total body area (968.0 cm(2)-928.6 cm(2), P = 0.017) and total body circumference (113.6 cm-111.4 cm, P = 0.016). The distance from fascia to skin decreased as well, almost to the point of statistical significance (3.3 cm-2.9 cm, P = 0.0505). Interestingly, fascia area and circumference did not decrease significantly after the operation (578.2 cm(2)-572.5 cm(2), P = 0.519, and 89.1 cm-88.6 cm, P = 0.394, respectively)., Conclusions: Morphomic analysis can be used to compare and pre- and post-operative changes in patients undergoing abdominal surgery. Our study demonstrates that component separation affects the dimensions of the entire abdomen, but leaves the fascia area and circumference relatively unchanged. These changes in the abdominal wall may help explain the muscular changes observed as a result of this operation and demonstrate that this is a functional operation that restores fascial area. By better defining the effects of this procedure, we can better understand the reason for its clinical success., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Sternal reconstruction with vascularized flaps is central to the management of sternal wound infections and mediastinitis but carries a high risk of complications. There is a need to identify reliable predictors of complication risk to help inform patients and clinicians in preparation for surgery. Unfortunately, body mass index and serum albumin may not be reliable predictors of complication rates. Analytic morphomics provides a robust quantitative method to measure patients' obesity as it pertains to their risk of complications in undergoing sternal reconstruction., Methods: We identified 34 patients with preoperative computed tomography scans of the abdomen from a cohort of sternal reconstructions performed between 1997 and 2010. Using semiautomated analytic morphomics, we identified the patients' skin and fascia layers between the ninth and 12th thoracic spine levels; from these landmarks, we calculated morphomic measurements of the patients' abdomens, including their total body cross sectional area and the cross sectional area of their subcutaneous fat. We obtained the incidence of complications from chart review and correlated the incidence of complications (including seroma, hematoma, recurrent wounds, mediastinitis, tracheostomy, and death) with patients' morphomic measurements., Results: Sixty-two percent of patients (n = 21) suffered complications after their operation. Those who suffered from complications, relative to those who did not have complications, had increased visceral fat area (12,547.2 mm(2)versus 6569.9 mm(2), P = 0.0080), subcutaneous fat area (16,520.2 mm(2)versus 8020.1 mm(2), P = 0.0036), total body area (91,028.6 mm(2)versus 67,506.5 mm(2), P = 0.0022), fascia area (69,238.4 mm(2)versus 56,730.9 mm(2), P = 0.0118), total body circumference (1101.8 mm versus 950.2 mm, P = 0.0017), and fascia circumference (967.5 mm versus 868.1 mm, P = 0.0077). We also demonstrated a significant positive correlation between the previously mentioned morphomic measurements and the incidence of complications in multivariate logistic regression models, with odds ratios ranging from 1.19-3.10 (P values ranging from 0.010-0.022)., Conclusions: Increases in abdominal morphomic measurements correlate strongly with the incidence of complications in patients undergoing sternal reconstruction. This finding may influence preoperative risk stratification and surgical decision making in this patient population., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Morphomics are three-dimensional measurements of aspects of the human anatomy generated by computed tomographic (CT) imaging. The purpose of this study was to generate preliminary data on the efficacy of morphomics, as a potential risk stratification tool, in predicting abdominal donor site wound-healing complications in patients undergoing abdominal perforator flap breast reconstruction. Patients and, Methods: In total, 58 consecutive patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction were evaluated. Using preoperative CT scan data, we quantified patients' body area, visceral and subcutaneous fat, fascia area, and body depth between T12 and L4. Associations between morphomic measures and complication rates were examined using t-tests and logistic regression., Results: Of the 58 patients, 11 (19%) patients developed a wound dehiscence and 47 (81%) patients healed their abdominal incision without complications. Patients with a dehiscence had a significantly higher body mass index (BMI) (34.32 vs. 29.26 kg/m(2), p = 0.014) than patients without a dehiscence. Multiple morphometric measures including higher visceral fat area (p = 0.003) were significant predictors of abdominal donor site wound dehiscence. BMI (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.03-1.32; p = 0.017) and visceral fat area (OR, 1.24; 95% CI, 1.08-1.42; p = 0.002) were independently significant predictors for wound dehiscence in the entire sample. Only visceral fat area retained its predictive ability in patients with a BMI > 30 kg/m(2)., Conclusions: Morphomic measurements correlate with the likelihood of developing postoperative donor site dehiscence after DIEP flap breast reconstruction. As a proof of concept study, this demonstrates that objective data obtained from CT scans may help in preoperatively assessing the risk for donor site wound healing complications in patients undergoing DIEP flap breast reconstruction., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Background: The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon., Methods: The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained., Results: The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced., Conclusion: The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

Introduction: Preoperative computed tomography (CT) evaluation of patients with nonsyndromic craniosynostosis (NSC) has focused on the bony cranial vault while ignoring the surrounding soft tissues. In this study, we posit that novel CT-derived temporal muscle and temporal fat pad morphomics (tissue thickness, area, and volume) can be used to calculate temporal morphomic indices (TMIs), which are unique to each NSC subtype (metopic, coronal, and sagittal) and divergent from normal individuals., Methods: High-throughput image analysis was used to reconstruct the 3-dimensional anatomy and quantify a TMI. These steps were completed in a semiautomated method using algorithms programmed in MATLAB v13.0. Differences in TMI across various craniosynostosis subtypes were assessed using Wilcoxon nonparametric tests for both patients with NSC and a control cohort of patients with trauma., Results: Using preoperative CT images, we evaluated 117 children with NSC from the University of Michigan Health System and 50 age-matched control patients between 1999 and 2011. Results indicate significant differences in TMI among the normal and NSC groups, with normal patients having significantly higher TMI values than patients with metopic, sagittal, and coronal synostosis. In addition, significant differences were found to exist between each craniosynostosis category., Conclusions: Patients with craniosynostosis demonstrate diminished temporalis muscle and overlying fat pad volume and thickness compared with control patients. The unique changes in temporal morphomics presented in this article demonstrate not only that the bony calvaria is affected by craniosynostosis but also that there exist quantifiable aberrations in the temporalis muscle and temporal fat pad. The methodologies described offer a novel methodology to use pre-existing CT scans to glean additional preoperative information on the soft tissue characteristics of patients with craniosynostosis.

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.

Background: Body mass index does not allow accurate risk stratification for individuals undergoing component separation repair of ventral hernias. The authors hypothesized that tissue morphology measurements (morphomics) of preoperative computed tomography scans stratify the risk of surgical site infection in patients undergoing ventral hernia repair with a component separation technique., Methods: The authors identified 93 patients who underwent component release ventral hernia repair (2004 to 2012). The surgical technique involved release of the external oblique muscle lateral to the linea semilunaris. Using analytic morphomic techniques, the authors measured patients' morphology using routine preoperative computed tomography scans. Two-sample t test was used to evaluate the effect of morphomic and demographic factors on surgical-site infection. Separate logistic regression analyses were performed on these morphomic factors to evaluate their predictive value in assessing the risk of surgical site infection, controlling for demographic covariates., Results: Surgical site infections were observed in 31 percent (n = 29) of the population. Subcutaneous fat area, total body area, and total body circumference had increased odds ratios for surgical site infection (p = 0.004, 0.014, and 0.012, respectively), indicating that these measures are better associated with surgical site infection than body mass index. These calculations control for demographic covariates, confirming that these morphomic parameters are predictive of surgical site infection., Conclusion: Specific morphomic values serve as superior predictors of surgical site infection in patients undergoing component separation technique hernia repair than currently used values such as body mass index., Clinical Question/level of Evidence: Risk, III.

Background: The triceps brachii muscle, the strongest extensor of the elbow joint, is characterized by the three heads: long, lateral and medial., Objectives: In the present study we aimed to examine the linear parameters (length, width) of the fetal triceps brachii muscle and to provide their growth dynamics., Material and Methods: Using anatomical dissection, digital image analysis (Multiscan v.14.02), and statistics (Student's t-test, regression analysis) we measured in mm the length and width of the triceps brachii in 30 fetuses of both sexes (12♂,18♀) aged 12-29 weeks., Results: Neither sex nor laterality differences were found. All the parameters studied increased proportionately with age. The linear functions were computed as follows: y = 6.797 + 2.079 x Age (r = 0.886) for length of the long head's belly, y = - 0.041 + 0.215 × Age (r = 0.786) for width of the long head's belly, y = 1.889 + 0.174 × Age (r = 0.796) for length of the long head's proximal tendon, y = 0.158 + 0.052 × Age (r = 0.864) for width of the long head's proximal tendon, y = 5.270 + 1.809 × Age (r = 0.855) for length of the lateral head's belly, y = 0.348 + 0.284 × A ge (r = 0.829) for width of the lateral head's belly, y = 0.942 + 1.837 × Age (r = 0.839) for length of the medial head's belly, y = 0.314 + 0.234 × Age (r = 0.852) for width of the medial head's belly, y = - 3.191 + 0.984 × Age (r = 0.929) for lenght of the common tendon, and y = - 0.478 + 0.133 × Age (r = 0.933) for width of the common tendon., Conclusions: Neither male-female nor right-left differences are observed in morphometric parameters of the triceps brachii muscle. The long head's belly is the thinnest, while the lateral head's belly is the widest one. The long head is the longest and the medial head is the shortest one. The developmental dynamics of the triceps brachii muscle follow proportionately.

Introduction: In adipose tissue healing, angiogenesis is stimulated by adipose-derived stromal stem cells (ASCs). Ventral hernia repair (VHR) patients are at high risk for wound infections. We hypothesize that ASCs from VHR patients are less vasculogenic than ASCs from healthy controls., Methods: ASCs were harvested from the subcutaneous fat of patients undergoing VHR by the component separation technique and from matched abdominoplasty patients. RNA and protein were harvested on culture days 0 and 3. Both groups of ASCs were subjected to hypoxic conditions for 12 and 24 hours. RNA was analyzed using qRT-PCR, and protein was used for western blotting. ASCs were also grown in Matrigel under hypoxic conditions and assayed for tubule formation after 24 hours., Results: Hernia patient ASCs demonstrated decreased levels of VEGF-A protein and vasculogenic RNA at 3 days of growth in differentiation media. There were also decreases in VEGF-A protein and vasculogenic RNA after growth in hypoxic conditions compared to control ASCs. After 24 hours in hypoxia, VHR ASCs formed fewer tubules in Matrigel than in control patient ASCs., Conclusion: ASCs derived from VHR patients appear to express fewer vasculogenic markers and form fewer tubules in Matrigel than ASCs from abdominoplasty patients, suggesting decreased vasculogenic activity.

Background: The psoas muscle has been shown to predict patient outcomes based on the quantification of muscle area using computed tomography (CT) scans. The accuracy of morphomic analysis on other muscles has not been clearly delineated. In this study, we determine the correlation between temporalis muscle mass, psoas muscle area, age, body mass index (BMI), and gender., Methods: Temporalis and psoas muscle dimensions were determined on all trauma patients who had both abdominal and maxillofacial CT scans at the University of Michigan between 2004 and 2011. Age, BMI, and gender were obtained through chart review. Univariate and multivariate analyses were performed to determine the relative relationship between morphomic data of the temporalis and psoas muscles and the ability of such information to correspond with clinical variables, such as BMI, age, and gender., Results: A total of 646 patients were included in the present study. Among the 249 (38.5%) women and 397 (61.5%) men, the average age was 49.2 y. Average BMI was 27.9 kg/m². Total psoas muscle area directly correlated with mean temporalis muscle thickness (r = 0.57, P < 0.001). There was an indirect correlation between age and psoas muscle area (r = -0.52, P < 0.001) and temporalis muscle thickness (r = -0.36, P < 0.001). Neither psoas nor temporalis measurements correlated strongly with BMI (r = 0.18, P < 0.001; r = 0.14, P = 0.002), although stronger correlations were found in a more "frail," subgroup as defined by a BMI of <20 (r = 0.59, P = 0.002)., Conclusions: We demonstrate that dimensions of the temporalis muscle can be quantified and may serve as a proxy for age. Going forward, we aim to assess the utility of temporalis and psoas morphomics in predicting complication rates among trauma patients admitted to the hospital to predict outcomes in the future., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Introduction: Patients with mandibular fracture often have comorbidities and concomitant injuries making the decision for when and how to operate a challenge. Physicians describe "temporalis wasting" as a finding that indicates frailty; however, this is a subjective finding without quantitative values. In this study, we demonstrate that decreased morphomic values of the temporalis muscle and zygomatic bone are an objective measure of frailty associated with increased injury-induced morbidity as well as negative impact on overall hospital-based clinical outcomes in patients with mandible fracture., Methods: Computed tomographic (CT) scans from all patients with a diagnosis of a mandible fracture in the University of Michigan trauma registry and with a hospital admission were collected from the years 2004 to 2011. Automated, high-throughput CT analysis was used to reconstruct the anatomy and quantify morphomic values (temporalis volume, area and thickness, and zygomatic thickness) in these patients using MATLAB v13.0 (MathWorks Inc, Natick, MA, USA). Subsequently, a subset of 16 individuals with a Glasgow Coma Scale of 14 or 15 was analyzed to control for brain injury. Clinical data were obtained, and the association between morphomic measurements and clinical outcomes was evaluated using Pearson correlation for unadjusted analysis and multiple regression for adjusted analysis., Results: The mean age of patients in the study was 47.1 years. Unadjusted analysis using Pearson correlation revealed that decreases in zygomatic bone thickness correlated strongly with increases in hospital, intensive care unit, and ventilator days (P < 0.0001, P = 0.0003, and P = 0.0017, respectively). Furthermore, we found that decreases in temporalis mean thickness correlated with increases in hospital and ventilator days (P = 0.0264 and P = 0.0306, respectively). Similarly, decreases in temporalis local mean thickness are significantly correlated with increases in hospital and ventilator days (P = 0.0232 and P = 0.0472, respectively)., Conclusions: Decreased thicknesses of the zygomatic bone and temporalis muscle are significantly correlated with higher hospital, ventilator, and intensive care unit days in patients with mandibular fracture receiving reconstructive operations. This morphomic methodology provides an accurate, quantitative means to evaluate craniofacial trauma patient frailty, injury, and outcomes using routinely obtained CT scans. In the future, we plan to apply this approach to determine preoperative risk stratification and assist in surgical planning.

Background: Estimates of blood loss during craniosynostosis surgeries have ranged from 42 to 126 percent of infant's total blood volume. Currently, no risk model has been developed to determine the likelihood of needing a blood transfusion. The authors propose an objective model, based on patients' three-dimensional anatomical characteristics, to stratify the likelihood of needing perioperative packed red blood cells., Methods: High-throughput image analysis from already ordered preoperative computed tomographic scans was used to reconstruct the three-dimensional anatomy of the temporalis muscle and overlying temporal fat pad. Using these morphomic measurements, the authors created a risk assessment model of the amount of packed red blood cells infused based on morphomic variations in temporal soft tissue., Results: The authors evaluated 139 infants with nonsyndromic craniosynostosis from the University of Michigan Health System. Results show the need for blood transfusion ranged from 94.1 percent among patients in the smallest quartile for temporal fat pad volume compared with 65.7 percent among the group with the largest quartile for temporal fat pad volume (p = 0.0057). Using multivariable linear regression, temporal fat pad volume (p = 0.012) and fat pad thickness (p = 0.036) were independent predictors for amount of packed red blood cells required., Conclusions: The authors demonstrate that patients with diminished temporal fat pad volume are significantly more likely to need increased packed red blood cell transfusions. In addition, by use of multivariable linear regression, their data suggest that temporal fat pad volume and thickness were independent predictors for the amount of required transfusion of packed red blood cells.

Introduction: Pierre Robin sequence (PR) and Treacher Collins syndrome (TC) are congenital disorders associated with multiple craniofacial abnormalities. The mandibular malformations linked with these maladies are closely associated with the form and function of the temporalis muscle. Despite these associations, a paucity of research has been directed at quantifying how these malformations affect the tissues of the temporal region. In this paper, we seek to quantify differences in the temporalis muscle and the temporal fat pad using a novel CT-derived analytic program to examine craniofacial morphomic indices within these patient groups in comparison to normal age-matched controls. We posit that the temporalis muscle and temporal fat pad, like other derivatives of the first branchial arch, are hypoplastic in patients with TC and PR compared to age-matched controls., Methods: High-throughput image analysis was used to reconstruct the 3-dimensional (3D) anatomy and quantify morphomic measures of the temporalis muscle and temporal fat pad in children with PR, TC, and age-matched controls. These steps were completed in a semi-automated method using algorithms programmed in MATLAB v13.0. The 3D reconstructions were analyzed in 3 children with PR (6 temporal regions), 3 children with TC (6 temporal regions), and a control group of 19 children (38 temporal regions). We also quantified the same measurements in a localized "core" sample in the area of greatest thickness, providing a more consistent sample of the tissue position. Relationships between the temporal muscle and fat pad values and craniofacial abnormality type were assessed using Wilcoxon nonparametric test using exact distribution, with a P value of less than 0.05 being deemed significant., Results: The mean age of our patients was 6.0 years in PR and 4.5 years in TC cohorts. We were able to establish an automated methodology to quantify the temporalis muscle and temporal fat pad based on CT characteristics. Localized temporalis volume and localized temporalis area were significantly smaller in children with PR than in the control group. Total temporalis fat volume and localized temporalis area were significantly less in children with TC than in the control group. When compared to each other, the PR group had small morphomic values compared to TC group., Conclusions: There are significant morphomic differences in the temporalis muscle and the temporal fat pad in children with either PR or TC when compared to age-matched control group which can be measured from pre-existing CT scans. Specifically, both of these test groups show decreases in the morphomic measures of the temporalis region. The quantification of these changes corroborates and objectifies the clinical findings associated with these congenital deformities while simultaneously allowing for preoperative planning. Furthermore, this finding confirms that the hypoplasia seen in these patient populations is not only hypoplasia of the mandible but also of the surrounding functional matrix, which includes the temporalis muscle and temporal fat pad.

Pierre Robin sequence and Treacher Collins syndrome are both associated with mandibular hypoplasia. It has been hypothesized, however, that the mandible may be differentially affected. The purpose of this study was to therefore compare mandibular morphology in children with Pierre Robin sequence with children with Treacher Collins syndrome using three-dimensional analysis of computed tomographic scans. A retrospective analysis was performed identifying children with Pierre Robin sequence and Treacher Collins syndrome undergoing computed tomography. Three-dimensional reconstruction was performed, and ramus height, mandibular body length, and gonial angle were measured. These were then compared with those in control children with normal mandibles and with the clinical norms corrected for age and sex based on previously published measurements. Mandibular body length was found to be significantly shorter for children with Pierre Robin sequence, whereas ramus height was significantly shorter for children with Treacher Collins syndrome. This resulted in distinctly different ramus height-mandibular body length ratios. In addition, the gonial angle was more obtuse in both the Pierre Robin sequence and Treacher Collins syndrome groups compared with the controls. Three-dimensional mandibular morphometric analysis in patients with Pierre Robin sequence and Treacher Collins syndrome thus revealed distinctly different patterns of mandibular hypoplasia relative to normal controls. These findings underscore distinct considerations that must be made in surgical planning for reconstruction.