Closure System Research Articles

Silk Bioprotein as a Novel Surgical-Site Wound Dressing: A Prospective, Randomized, Single-Blinded, Superiority Clinical Trial.

Medical adhesive-related skin injuries (MARSIs) affect about 1.5 million patients annually in the United States. Complications include allergic contact dermatitis, skin blistering, skin tears, and surgical-site infections (SSIs). The authors hypothesize that a natural hypoallergenic silk bioprotein wound dressing will decrease the incidence of MARSI in comparison to a synthetic alternative. This study aimed to assess the efficacy and safety of a silk bioprotein wound dressing compared to the Dermabond Prineo (Ethicon, Inc., Somerville, NJ) skin closure system. This prospective, randomized, single-blinded trial studied 25 patients who were dressed with Dermabond Prineo on one side of their body and on the contralateral side with the silk bioprotein dressing after undergoing abdominoplasty or reduction mammaplasty procedures. Data were collected over 5 postoperative visits using photographs and an investigator administered questionnaire to track rash, itch, discomfort, erythema, edema, SSIs, need for pharmaceutical intervention, mechanical injury, removal time, and bathing routines. Sixty-four percent (16/25) of patients characterized the severity of discomfort as a score of 4 out of 10 or greater on the Dermabond Prineo control side and only 4% (1/25) for the silk-dressing side (P < .001). Fifty-two percent (13/25) had a visible rash of 4 or higher on the Dermabond Prineo side of their incision and 0% (0/25) had a rash on the silk side (P < .001). Fifty-two percent (13/25) required steroids or antibiotics to treat MARSI to Dermabond Prineo and 0% (0/25) required pharmaceutical intervention on the silk side (P < .001). The use of a silk bioprotein wound dressing significantly reduces the incidence of MARSI throughout the postoperative period.

L-fuzzy algebraic substructure

This article aims to provide a method for defining L-fuzzy algebraic substructures on general algebras. Concretely, the properties of L-fuzzy sets are first reviewed, and their representations are then provided. Next, algebraic substructures are generalised as the closure systems on the power set of the algebra, and the properties of the prime and maximal elements in the above closure system are investigated. Based on these facts, L-fuzzy algebraic substructures with respect to the closure system are defined and studied. Two equivalence characterisations of the sup property of the ordered set L are provided using L-fuzzy substructures. Similarly, some properties of L-fuzzy prime and maximal substructures with respect to the closure system are discussed. Finally, to demonstrate the broad applicability of the theory of L-fuzzy algebraic substructures, the theory is applied to some specific algebraic structures, such as groups and pseudo MV-algebras.

Use of the VenaSeal closure system for the treatment of varicose veins

Abstract Background: The VenaSeal Closure System (Medtronic, Dublin, Ireland) is an approved non-tumescent, non-thermal, and non-sclerosant treatment for patients with symptomatic varicose veins. All patients with the great saphenous vein (GSV) having a closure rate of 100% experienced minor complications, indicating the safety and effectiveness of the VenaSeal Closure System as venous reflux disease treatment. Objectives: Venous reflux disease treatment includes surgical high ligation and stripping of the GSV in association with phlebectomy of individual varicosities. However, the procedure requires general anesthesia and several days of hospitalization, causing side effects such as postoperative pain, bruising, and sensory nerve damage. Recently, the VenaSeal Closure System is the only approved non-tumescent, non-thermal, and non-sclerosant treatment for patients with symptomatic varicose veins. Thus, this study aimed to evaluate the safety and effectiveness of the VenaSeal Closure System as a treatment option for patients with venous reflux disease. Methods: This retrospective clinical study used data from 19 patients who received the VenaSeal Closure System for venous reflux disease from October 2019 to December 2020 in a general district hospital. Results: The analysis identified 19 patients, of which two had bilateral leg involvement. The mean patient age was 62.21 ± 15.15 years. The GSV mean diameter was 8.57 ± 5.56 mm. The procedure time was 25 ± 2.89 min. Of the 21 legs, 19 had symptoms, mainly severe pain. Among those 21 legs with the branch of the touristy vein from the GSV, seven needed adjunctive therapy like phlebectomy. The overall complication rate was low. Of these 21 legs, 17 had no major complications, one had mild erythematous change, two had mild edema, and one had redness with pain at the medial thigh. The closure rate of the GSV was 100% as detected by sonography after 1 month in all patients. Conclusion: All patients with GSV having a closure rate of 100% experienced minor complications, indicating the safety and effectiveness of the VenaSeal Closure System as venous reflux disease treatment.

Method of surgical treatment of recurrent pleural empyema with bronchial fistula after right pneumonectomy for destructive drug-resistant pulmonary tuberculosis

Introduction. The treatment of patients with recurrent empyema of the pleural cavity associated with bronchial fistula of the main bronchus has been an urgent problem in phthisiosurgery for many decades. There are non-radi-cal methods of treatment using various variants of bron-cho-obturators and radical methods of treatment, but ac-companied by high trauma due to chest decostation. The authors proposed an original method for the elimination of recurrent bronchial fistula and pleural empyema after right pneumonectomy while preserving the frame of the chest. Materials and methods. A retrospective study for the period from 2016 to 2023 included 9 patients who were operated on for empyema of the pleural cav-ity with a fistula of the right main bronchus according to the original method after previous pneumonecto-my. The duration of the fistula before surgery ranged from 4 to 42 months. Bacterial excretion in sputum was preserved in 3 (33.4%) patients. 8 (88.8%) patients had pre-XDR MTB and only 1 (11.1%) had MDR MTB. In all patients, a mixed (specific and non-specific) flora was determined in the pleural fluid. The surgical strategy was multi-staged. At the first stage, upper-posterior thoracoplasty, thoracotomy, resection of the stump of the right main bronchus, its suturing and myoplasty were performed. At the second stage, an open cleaning of the pleural cavity was performed with tamponage of the residual empyema cavity from the thoracostomy, after that vacuum asssisted closure system was applied to the thoracostomy. At the third stage, myoplastic closure of the thoracostomy was performed. The im-mediate and long-term results of treatment of patients were evaluated. Results. All patients were operated on by the same surgical team. In all cases, resection of the stump of the right main bronchus was performed, for a length of 2 mm to 5 mm. Histological examination of the bronchial resection margin did not reveal tubercu-lous lesions. In the postoperative period, surgical com-plications requiring invasive interventions to eliminate them occurred in 22.2%. In 8 (88.8%) patients, the result of treatment was regarded as satisfactory (persistent absence of fistula, absence of progression of pleural empyema). In a patient with persistent recurrence of the fistula, the result of treatment is regarded as unsat-isfactory. In the long-term period, all patients with satis-factory surgical treatment were removed from the dis-pensary register, data for recurrence of empyema and bronchial fistula were not obtained during the control examination. Against the background of anti-tuberculo-sis chemotherapy, a clinical cure of tuberculosis of the sole lung was achieved with the formation of metatu-berculous fibrotic focal changes without destruction. All patients were persistently abacillated. Conclusion. The proposed multi-stage therapeutic surgical tactics for recurrent empyema of the pleural cavity associated with bronchial fistula of the main bronchus is an optimal alternative to supertraumatic and non-radical methods, since it allows reliable elimination of chronic, often re-current, bronchial fistula with successful treatment of empyema of the residual pleural cavity, and is also ac-companied by low traumatism and the best cosmetic effect while maintaining the frame of the chest wall

A case of a contusion wound on the forearm that was successfully treated with the 3M&lt;sup&gt;TM&lt;/sup&gt;Snap&lt;sup&gt;TM&lt;/sup&gt; Negative Pressure Closure System and grafted only as an outpatient

A case of a contusion wound on the forearm that was successfully treated with the 3M&lt;sup&gt;TM&lt;/sup&gt;Snap&lt;sup&gt;TM&lt;/sup&gt; Negative Pressure Closure System and grafted only as an outpatient

Management of arterial trauma during central venous catheter insertion using a percutaneous suture-mediated closure device (Perclose ProGlide): a report of two cases and literature review

We evaluated the safest approach to treat catheter-related cervicothoracic arterial injuries by reviewing two inadvertent arterial injury cases during central venous catheter insertion and their related complications at an intensive care unit. In the first case, C-arm angiography confirmed accidental catheter placement in the right subclavian artery (SCA). In the second case, accidental catheter placement in the right common carotid artery was confirmed via computed tomography angiography of the neck and chest. The catheter was connected to a high-pressure arterial bag in both cases. The Perclose ProGlide Suture-Mediated Closure System (Abbott Laboratories, IL, USA) was used and successfully operated the two cases of iatrogenic SCA and carotid artery injuries. A follow-up bedside ultrasound at 2 and 6 hours postoperatively revealed normal Doppler waveforms in the inadvertent arterial injury and distal arteries without hematoma at the puncture site in both cases. In conclusion, for inadvertent artery puncture, which occurs in &lt;12% of jugular and subclavian venous procedures, the endovascular approach using a covered stent appears to be safe for treating the accidental catheter placement in the carotid artery, although some cases of post-procedure stroke have been reported. In this regard, the percutaneous arterial suture device (Perclose ProGlide) offers an almost 100% success rate and lowers morbidity and mortality rates compared with open surgical and endovascular approaches for treating iatrogenic SCA and carotid artery injuries. These two cases highlight the effectiveness of minimally invasive percutaneous arterial closure devices in treating this infrequent but potentially lethal injury.

A novel anastomotic vacuum-assisted closure system for cervical anastomotic fistula after three-incisional esophagectomy.

A novel anastomotic vacuum-assisted closure system for cervical anastomotic fistula after three-incisional esophagectomy.

Fuzzy closure structures as formal concepts

Galois connections seem to be ubiquitous in mathematics. They have been used to model solutions for both pure and application-oriented problems. Throughout the paper, the general framework is a complete fuzzy lattice over a complete residuated lattice. The existence of three fuzzy Galois connections (two antitone and one isotone) between three specific ordered sets is proved in this paper. The most interesting part is that fuzzy closure systems, fuzzy closure operators and strong fuzzy closure relations are formal concepts of these fuzzy Galois connections.

A note on closure spaces determined by intersections

In this work, we study a kind of closure systems (c.s.) that are defined by means of intersections of subsets of a support X with a (fixed) closed set T. These systems (which will be indicated by M(T)-spaces) can be understood as a generalization of the usual relative subspaces. Several results (referred to continuity and to the ordered structure of families of M(T)-spaces) are shown here. In addition, we study the transference of properties from the ``original closure spaces (X,K) to the spaces (X,M(T)). Among them, we are interested mainly in finitariness and in structurality. In this study of transference, we focus our analyisis on the c.s. usually known as abstract logics, and we show some results for them.

Dual digraphs of finite semidistributive lattices

Dual digraphs of finite join-semidistributive lattices, meet-semidistributive lattices and semidistributive lattices are characterised. The vertices of the dual digraphs are maximal disjoint filter-ideal pairs of the lattice. The approach used here combines representations of arbitrary lattices due to Urquhart (1978) and Ploščica (1995). The duals of finite lattices are mainly viewed as TiRS digraphs as they were presented and studied in Craig--Gouveia--Haviar (2015 and 2022). When appropriate, Urquhart's two quasi-orders on the vertices of the dual digraph are also employed. Transitive vertices are introduced and their role in the domination theory of the digraphs is studied. In particular, finite lattices with the property that in their dual TiRS digraphs the transitive vertices form a dominating set (respectively, an in-dominating set) are characterised. A characterisation of both finite meet-and join-semidistributive lattices is provided via minimal closure systems on the set of vertices of their dual digraphs.

Same-day discharge following catheter ablation and venous closure with VASCADE MVP: A postmarket registry.

Early and safe ambulation can facilitate same-day discharge (SDD) following catheter ablation, which can reduce resource utilization and healthcare costs and improve patient satisfaction. This study evaluated procedure success and safety of the VASCADE MVP venous vascular closure system in patients with atrial fibrillation (AF). The AMBULATE SDD Registry is a two-stage series of postmarket studies in patients with paroxysmal or persistent AF undergoing catheter ablation followed by femoral venous access-site closure with VASCADE MVP. Efficacy endpoints included SDD success, defined as the proportion of patients discharged the same day who did not require next-day hospital intervention for procedure/access site-related complications, and access site sustained success within 15 days of the procedure. Overall, 354 patients were included in the pooled study population, 151 (42.7%) treated for paroxysmal AF and 203 (57.3%) for persistent AF. SDD was achieved in 323 patients (91.2%) and, of these, 320 (99.1%) did not require subsequent hospital intervention based on all study performance outcomes. Nearly all patients (350 of 354; 98.9%) achieved total study success, with no subsequent hospital intervention required. No major access-site complications were recorded. Patients who had SDD were more likely to report procedure satisfaction than patients who stayed overnight. In this study, 99.7% of patients achieving SDD required no additional hospital intervention for access site-related complications during follow-up. SDD appears feasible and safe for eligible patients after catheter ablation for paroxysmal or persistent AF in which the VASCADE MVP is used for venous access-site closure.

Aggressive management of extensive de gloving injury of the left lower limb with debridement and split skin grafting and application of vacuum-assisted closure system over recipient grafting site in a tertiary health care setup

Aggressive management of extensive de gloving injury of the left lower limb with debridement and split skin grafting and application of vacuum-assisted closure system over recipient grafting site in a tertiary health care setup

Using of Vacuum Assisted Closure System in Treatment of Post Sternotomy Mediastinitis Systematic Review and Meta-Analysis

Using of Vacuum Assisted Closure System in Treatment of Post Sternotomy Mediastinitis Systematic Review and Meta-Analysis

Wound closure with a mesh and liquid tissue adhesive (Dermabond Prineo) system in pediatric spine surgery: a prospective single-center cohort study incorporating parent-reported outcome measures.

Wound healing can be challenging in children undergoing spine surgery for neurological conditions due to a high risk of cerebrospinal fluid (CSF) leakage and wound infection. In adults, use of the Dermabond Prineo (DP) skin closure system, which consists of both tissue adhesive glue and a self-adhesive mesh, for wound closure of medium-length surgical incisions has been reported. The aim of this study was to investigate the efficiency and cosmetic outcome of DP for wound closure in extra- and intradural pediatric neurological spine surgery. In this prospective cohort study, 47 children underwent 50 spine procedures using DP for wound closure between 2018 and 2022 at a single institution. Patient demographic and surgical data were collected. The primary outcome was revision surgery for wound healing disorders, while secondary outcomes were infections, minor wound healing disorders, and both physician and parental satisfaction (parent-reported outcome measures [PROMs]) at last follow-up. Among 50 spinal (45 intra- and 5 extradural) interventions, 1 patient (2%) underwent revision surgery for a cutaneous CSF fistula and pseudomeningocele. Minor wound healing disorders occurred after 16 surgeries, which did not require surgical wound revision and resolved completely. No allergic reactions to DP or surgical site infections within 30 days were observed. The parents and the medical team described wound care as significantly facilitated since wound dressing changes were not needed. Three families (6.4%) encountered difficulties in wound care, and 46 (97.9%) were satisfied with DP. The cosmetic outcome based on PROMs was excellent, with a mean score of 8 (IQR 2) on a scale from 1 to 10. At long-term follow-up, a mean of 11.3 ± 10.7 months after surgery, physicians rated the cosmetic outcome on the visual analog scale (median score 9, IQR 1) and Hollander scale (median score 6, IQR 1). The outcomes were similar among the different pathologies and age groups and did not differ in patients with and without syndromic malformations. The application of DP is simple, enables good patient comfort, facilitates both professional and parental wound care, and leads to excellent cosmetic results. DP possibly aids in the reduction of postoperative CSF leakage and infections after pediatric neurological spine surgery.

Machine Learning Moment Closure Models for the Radiative Transfer Equation III: Enforcing Hyperbolicity and Physical Characteristic Speeds

This is the third paper in a series in which we develop machine learning (ML) moment closure models for the radiative transfer equation. In our previous work (Huang et al. in J Comput Phys 453:110941, 2022), we proposed an approach to learn the gradient of the unclosed high order moment, which performs much better than learning the moment itself and the conventional \(P_N\) closure. However, while the ML moment closure has better accuracy, it is not able to guarantee hyperbolicity and has issues with long time stability. In our second paper (Huang et al., in: Machine learning moment closure models for the radiative transfer equation II: enforcing global hyperbolicity in gradient based closures, 2021. arXiv:2105.14410), we identified a symmetrizer which leads to conditions that enforce that the gradient based ML closure is symmetrizable hyperbolic and stable over long time. The limitation of this approach is that in practice the highest moment can only be related to four, or fewer, lower moments. In this paper, we propose a new method to enforce the hyperbolicity of the ML closure model. Motivated by the observation that the coefficient matrix of the closure system is a lower Hessenberg matrix, we relate its eigenvalues to the roots of an associated polynomial. We design two new neural network architectures based on this relation. The ML closure model resulting from the first neural network is weakly hyperbolic and guarantees the physical characteristic speeds, i.e., the eigenvalues are bounded by the speed of light. The second model is strictly hyperbolic and does not guarantee the boundedness of the eigenvalues. Several benchmark tests including the Gaussian source problem and the two-material problem show the good accuracy, stability and generalizability of our hyperbolic ML closure model.

Analysis of Reported Adverse Events Related to Over-the-Scope Clips: A MAUDE Database Analysis

Background and AimsOver-the-scope clips (OTSCs) have been increasingly used in the management of bleeding, perforations, fistulae, and anastomotic leaks in the gastrointestinal tract. However, since their Food and Drug Administration (FDA) approval in 2010, data on the adverse events of OTSC systems have been lacking. The aim of our study was to report and analyze adverse events and device failures associated with OTSC systems using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. MethodsWe analyzed the FDA MAUDE database post-marketing surveillance data from January 2013 through May 2022 on the two OTSC systems available in the United States. ResultsForty medical device reporting claims were found from January 2013 through May 2022. Adverse events were classified as device-related problems and patient-related adverse events. Forty device-related problems were reported, along with 20 device-related adverse events. Most device-related problems were reported in the Padlock defect closure system (n = 23), followed by the Padlock pro clip system (n = 8) and Ovesco OTSC system (n = 9). The most common device-related problem was related to the failure of OTSC deployment (n = 13), followed by material protrusion or extrusion (n = 7). The most common patient adverse events were perforation (n = 4), esophageal laceration (n = 4), bleeding (n = 3), and luminal stenosis (n = 3). All 4 patients required surgical management of the perforation. No deaths related to the use of OTSCs were reported. ConclusionFailure of OTSC deployment and perforation were the most common device-related problem and patient-related adverse event, respectively. As the use of OTSC systems continues to increase, it is important for endoscopists to be mindful of both the common and rare adverse events associated with OTSC use.

Implication of Data Obtained from Real Time Stability Studies of Pharmaceutical Preparations

The major reason for carrying out stability studies of a drug product is to establish the shelf life of a drug during the period of storage so as to guarantee its quality, effectiveness and safety. Real time stability studies data from 2018-2022 were obtained from selected pharmaceutical industries located within North Central, Nigeria. The analysis of variance (ANOVA) of the data obtained for the real time stability studies was carried out using IBM SPSS Statistics Version 23. The results obtained showed that both chemical and microbiological parameters checked were within the pre-set specifications despite the changes in the results as the storage increases due to environmental factors such as: temperature, humidity, light, exposure to oxygen and container –closure system used for the packaging of the drug product. Pathogenic bacteria such as: Escherichia coli, Staphylococcus aureus, Salmonella typhimurium and Pseudomonas aeruginosa recorded 0.00 cfu/ml and the values obtained for total viable aerobic mesophilic bacteria plate count and fungi were within the pre-set specifications while Staphylococcus aureus and Candida albicans were sensitive to Methylated Spirit. There was a significant difference in the data analysed (P&lt;0.05). The implication of this study is that the drug product may not be stable if the shelf life increases beyond what was stated for them. Hence, these results provided clues to how the quality of the product changes with time under different environmental factors (temperature, relative humidity, exposure to oxygen and light) and the interaction between the drug product and container-closure system used. This study suggests the need for pharmaceutical industries to continuously carry out stability studies of drug products in order to know the changes that may likely occur during the storage and to establish the shelf life of the drug product.

Percutaneous Approach in Endovascular Aortic Procedures Using a Suture-Mediated Closure Device.

The purpose of this study is to assess the efficacy of a suture-mediated closure device during percutaneous endovascular aortic repair. A single-center, retrospective analysis of patients undergoing endovascular repair for infrarenal, thoracic and thoracoabdominal aortic aneurysms and aortic dissections via percutaneous femoral access between April 2017 and June 2021 was performed. The primary endpoint of the study was the efficacy and technical success of the Perclose ProGlide closure device during percutaneous endovascular procedures. The secondary endpoints were intraoperative and postoperative inguinal and vascular complications during and after device use. A total of 376 punctures were performed in 263 patients with the deployment of the ProGlide vascular closure system. Twenty-two cases involved percutaneous re-puncture as part of a staged procedure. The primary and secondary technical success rates were 93.1% (350/376) and 94.7% (356/376), respectively. In 20 patients (5.3%), intraoperative femoral exposure due to complications was required. Postoperative complications occurred in 13 cases (3.5%), 2 of which required surgical reintervention. There was no statistical significance between the type of endovascular procedure and primary technical success (p = 0.56). The introduction of larger-diameter sheaths was not associated with increased intraoperative and postoperative complication rates (p = 0.75 and p = 0.78, respectively). Percutaneous re-puncture of the vascular access site did not result in a lower overall technical success rate (20/22, 90.9% primary technical success rate, p = 0.67; 21/22, 95.5% secondary technical success rate, p = 0.86) or an increased number of perioperative complications (1/22, 4.5% intraoperative complications, p = 0.86; 2/22, 9.1% postoperative complications, p = 0.13). The application of the ProGlide closure system is a safe and efficient method to achieve hemostasis during percutaneous endovascular aortic repair. Complex aortic pathologies, which often require a staged approach with re-puncture, can also be successfully treated with this closure system.

A Nationwide Survey Aimed at Establishing an Appropriate Long-Term Storage and Management System for Fertility Preserving Specimens in Japan.

Purpose: The demand for fertility preservation continues to grow as cancer treatment outcomes improve. The specimen storage period is longer for fertility preservation than for conventional fertility treatment; therefore, a robust management system for stored specimens is required. We conducted the first national survey in Japan on the management of cryopreserved specimens in fertility preservation facilities. Methods: Questionnaires were mailed to 130 fertility preservation facilities. Primary outcomes included the official position of the storage manager, support system in case of facility closure, disaster countermeasures, management and operating system for liquid nitrogen storage containers, preservation costs, and method to confirm the intention to continue storage. Results: The response rate was 63.8%. The facility director most commonly functioned as the storage manager (59.0%). In case of facility closure, 20.5% had an approved transfer site; 59.0% had not made any decisions. In the management of liquid nitrogen containers, 83.1% regularly replenished the liquid nitrogen, 65.1% regularly checked the amount, and 16.9% had alarm monitoring systems. Regarding disaster countermeasures, 70.9% had taken measures to protect specimens. Conclusion: This survey revealed issues such as disparities among facilities regarding long-term specimen storage systems. Accordingly, management standards for fertility preservation facilities should be established.

Abstract 14772: Comparing Efficacy of Venous Closure Devices in Patients Undergoing Atrial Fibrillation and Atrial Flutter Ablation: A Retrospective Review

Introduction: Vascular closure devices have shown marked improvement in patient comfort and time to ambulation after undergoing atrial fibrillation (AF) and atrial flutter (AFL) radiofrequency ablation. They have been proven superior to manual closure and Figure of 8 suture in terms of pain control and time to ambulate. However, data comparing different vascular closure devices is sparse. Hypothesis: To compare the efficacy of venous closure devices Methods: We retrospectively reviewed 100 patients at our institution who underwent AF and AFL radiofrequency ablation. We aimed to assess the difference in time to ambulation, device failure, pain control and vascular complication rate between the two commonly used venous closure devices (VASCADE and PERCLOSE). Results: A total of 100 patients (50 in each arm) were included in the study. The mean age was 67.6 + 9.3 years and 73% patients were men. The two groups were well balanced with respect to baseline demographics and clinical characteristics except for coronary artery disease (24% VASCADE vs. 14% PERCLOSE, p &lt;0.001). No significant difference was observed in time to ambulate between PERCLOSE (2 + 0.21 hours) vs VASCADE (2 + 0.23 hours); p=0.74. 8% patients (n=4) in VASCADE arm required additional PERCLOSE to achieve hemostasis. 4% (n=2) patients in PERCLOSE arm required opioids for pain management; compared to none in VASCADE arm. No closure device related complications were observed in either arm. Conclusions: Both venous vascular closure systems offer similar efficacy in terms of time to ambulate. However, PERCLOSE was used in addition to VASCADE in a few instances to achieve hemostasis.