Efficiency Analysis of Hemostatic Agents in Drainless Neck Surgery: Cellulose-Based Versus Liquid Fibrin Sealants.

PURPOSE:  Using liquid fibrin sealants has once again questioned the benefit of drain placement in head and neck operations. Cellulose-based hemostats offering different hemostasis mechanisms have scarcely been investigated in drainless neck surgeries. This study aimed to evaluate whether liquid fibrin sealant offers any advantage over cellulose-based hemostats in various head and neck surgeries. METHODS: A prospective trial of patients who underwent various neck surgeries between 2020 and 2022. Baseline characteristics and postoperative outcomes were compared between the drain-placed and the drainless groups, with the latter sub-categorized into three groups: fibrin sealant, cellulose-based hemostats, and a combination of both. RESULTS: A total of 119 patients were included (63 thyroidectomies, 40 parathyroidectomies, and 16 sialoadenectomies). Fifty eight had a drain placed and 61 had no drain. In the drainless group, 23 patients received cellulose-based absorbable hemostats (SURGICEL®/ FIBRILLAR™); 18 patients had fibrin sealants (EVICEL®/TachoSil®/TISSEEL); in 16, a combination of both was used; and in four patients, no hemostatic agent was used. Three (5%) of the 61 drainless patients developed a seroma compared to one (2%) seroma in the drain-placed patients. No advantage was demonstrated using a combination of FIBRILLAR™ with a fibrin sealant nor for any used separately. Drain placement delayed patient discharge by at least one day compared to the group without a drain (p < 0.001). CONCLUSION: Drain placement offered a minor advantage in the postoperative course reducing rates of seroma formation, while delaying patient discharge by at least one day. There was no advantage in using a specific hemostatic agent over the other.

Consensus of the Brazilian association of hematology, hemotherapy and cellular therapy on patient blood management: Intraoperative hemostasis and volume replacement.

Hemostasis plays a critical role in surgical procedures and is essential for a successful outcome. Advances in hemostatic agents offer new approaches to controlling bleeding thereby making surgeries safer. The appropriate choice of these agents is crucial. Volume replacement, another integral part of Patient Blood Management (PBM), maintains adequate tissue perfusion, preventing cellular damage. Individualization in fluid administration is vital with the choice between crystalloids and colloids depending on each case. Colloids, unlike crystalloids, increase oncotic pressure, contributing to fluid retention in the intravascular space. Understanding these aspects is essential to ensure safe and effective surgery, minimizing complications related to blood loss and maintaining the patient's hemodynamic status.

TAVAC: comprehensive review of currently available hemostatic products as adjunct to surgical hemostasis.

BACKGROUND: The use of hemostatic agents by general surgeons during abdominal operations is commonplace as an adjunctive measure to minimize risks of postoperative bleeding and its downstream complications. Proper selection of products can be hampered by marginal understanding of their pharmacokinetics and pharmacodynamics. While a variety of hemostatic agents are currently available on the market, the choice of those products is often confusing for surgeons. This paper aims to summarize and compare the available hemostatic products for each clinical indication and to ultimately better guide surgeons in the selection and proper use of hemostatic agents in daily clinical practice. METHODS: We utilized PubMed electronic database and published product information from the respective pharmaceutical companies to collect information on the characteristics of the hemostatic products. RESULTS: All commercially available hemostatic agents in the US are described with a description of their mechanism of action, indications, contraindications, circumstances in which they are best utilized, and expected results. CONCLUSION: Hemostatic products come with many different types and specifications. They are valuable tools to serve as an adjunct to surgical hemostasis. Proper education and knowledge of their characteristics are important for the selection of the right agent and optimal utilization.

A Prospective Analysis of the Effects of a Powder-Type Hemostatic Agent on the Short-Term Outcomes after Liver Resection.

Background and Objectives: Postoperative bleeding is a significant cause of morbidity and mortality following liver resection. Therefore, it is crucial to minimize bleeding during liver resection and effectively manage it when it occurs. Arista® AH (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) is a microporous polysaccharide hemosphere (MPH), a new plant-derived polysaccharide powder hemostat that can be applied to the entire surgical field. This study prospectively assessed the effectiveness of Arista for bleeding control when applied intraoperatively to the liver resection surface. Materials and Methods: Data were collected at Seoul National University Bundang Hospital for patients who underwent liver resection owing to malignant hepatocellular carcinoma or benign liver diseases. We compared the outcomes between 45 patients managed with Arista® AH (data were prospectively collected between September 2022 and May 2023) and 156 patients managed without the use of Arista® AH (data were retrospectively collected between January 2021 and December 2021). Results: There were no significant differences in patient characteristics between the two groups. The estimated blood loss (EBL) was significantly lower in the Arista® AH group compared with the control group (495.56 ± 672.7 mL vs. 691.9 ± 777.5 mL, p = 0.049). The mean postoperative hospital stay was significantly shorter in the Arista® AH group (5.93 ± 1.88 days vs. 6.94 ± 4.17 days, p = 0.024). The time to Jackson-Pratt drain removal was also significantly shorter in the Arista® AH group (4.64 ± 1.31 days vs. 5.30 ± 2.87 days, p = 0.030). The patient subgroup was divided into four categories based on the type of resection and the presence or absence of cirrhosis. Within the subgroup of major resections in non-cirrhotic patients, the Arista® AH group demonstrated significantly better outcomes compared to the control group, showed lower EBL, reduced need for blood transfusions, decreased volume of drain fluid collected within 48 h, earlier removal of drains, and shorter hospital stays. In contrast, for the other subgroups such as minor resection (both non-cirrhotic and cirrhotic) and major resection with cirrhosis, the differences between the Arista® AH and control groups in various parameters like EBL, blood transfusion rates, drain fluid volume, time to drain removal, and duration of hospital stay were not statistically significant. Conclusions: Arista® AH significantly improved intraoperative blood management and postoperative recovery in patients undergoing liver resection, particularly in non-cirrhotic patients who underwent major resection.

Expert panel recommendations for topical hemostatic agent use in varied bleeding sites and situations during neuro-spine surgeries.

Intraoperative bleeding poses a substantial challenge, particularly in neuro-spine surgeries leading to complications such as hematomas, infections, and hemodynamic instability. Despite their proven efficacy, use of topical hemostatic agents (THAs) lacks comprehensive published literature and guidelines particularly in the Indian setting. The present study provides the first-ever Indian expert panel recommendations for effective adjunct THA use in different intraoperative bleeding sites and situations in neuro-spine surgeries. A comprehensive approach, encompassing a literature review, followed by experience sharing in a meeting using a survey helped integrate expert opinions in the form of practical algorithms to guide THA selection. Our survey results revealed a strong inclination towards specific THAs, flowable gelatin + thrombin being choice of THA for difficult to access and problematic bleeding situations during tumor removal/resection, transsphenoidal hypophysectomy and skull-based procedures. Both oxidized regenerated cellulose (ORC)/Fibrillar and flowable gelatin + thrombin were recommended for continuous oozing. ORC/Fibrillar was preferred for arteriovenous and cavernous malformations. This expert-panel guidance on THA use aims to optimize hemostat use practices and improve surgical outcomes in neuro-spine surgery.

Topical hemostatic agents in spinal surgery.

Spinal surgery can be associated with significant intraoperative blood loss which may lead to various complications. As the number of patients undergoing spinal surgery increases over time, accurate and effective hemostasis becomes critically important. Despite various surgical hemostatic techniques, conventional interventions such as compression, suture, ligation, and heat-generating cautery, are not suitable for osseous and epidural venous plexus bleeding during spinal procedures. Therefore, a variety of hemostatic agents have been developed to promote hemostasis. As they differ in terms of mechanism, form, application and potential adverse reactions, it is important to understand the natural features of existing agents. Here we comprehensively review currently available topical hemostatic agents from different sources and summarize their mechanisms of action, applications, and current or potential utilization in spinal surgery. We found hemostatic agents from different sources exert hemostatic actions through different mechanisms. In addition, topical hemostatic agents play various roles in spinal surgery including as hemostatic agent, dura mater repair, drug-carrier, skin closure, and fibrosis prevention. Compressive neurological complications are the most common complications of these hemostatic agents. Therefore, optimal use in spinal environments should match their features, indications, and efficacy with clinical conditions.

Consensus of the Brazilian association of hematology, hemotherapy and cellular therapy on patient blood management: Intraoperative hemostasis and volume replacement

Abstract Hemostasis plays a critical role in surgical procedures and is essential for a successful outcome. Advances in hemostatic agents offer new approaches to controlling bleeding thereby making surgeries safer. The appropriate choice of these agents is crucial. Volume replacement, another integral part of Patient Blood Management (PBM), maintains adequate tissue perfusion, preventing cellular damage. Individualization in fluid administration is vital with the choice between crystalloids and colloids depending on each case. Colloids, unlike crystalloids, increase oncotic pressure, contributing to fluid retention in the intravascular space. Understanding these aspects is essential to ensure safe and effective surgery, minimizing complications related to blood loss and maintaining the patient's hemodynamic status.

Efficacy of four different hemostatic agents in thyroid surgery in reducing the amount of post-operative fluid collection.

PURPOSES: Postoperative bleeding remains a life-threatening complication in thyroid surgery. The aim was to assess the efficacy of four different hemostatic agents, Collagen-Fibrinogen-Thrombin Patch (CFTP) in two sizes (3 × 2.5 cm and 9.5 × 4.8 cm), polysaccharide particles (1 g) and Cellulose Gauze (2.5 × 5 cm) on postoperative drainage volume (DV) compared to a control group. METHODS: We included from October 2007 until Mai 2011, 150 patients (30 per group) for this monocentric, retrospective case-controlled study. Patients were scheduled for a hemithyroidectomy or thyroidectomy. The primary endpoint was the postoperative DV within the first 24 h, secondary the incidence of adverse events. RESULTS: There were no difference in demographic parameters. The mean DV (± SD) was 51.15 (± 36.86) ml in the control, 50.65 (± 42.79) ml in small (3 × 2.5 cm), 25.38 (± 23.99) ml in large CFTP (9.5 × 4.8 cm), 53.11 (± 39.48) ml in the polysaccharide particles and 48.94 (± 30.59) ml in the cellulose gauze group. DV was significantly reduced with the large CFTP (p < 0.05) compared to all other groups. There were no adverse events. CONCLUSIONS: We were able to demonstrate a significant reduction in the DV for the large CFTP group compared to the other collectives. Although this as being associated with not inconsiderable costs and we would only recommend its use for high-risk patients only.

El empleo del ácido tranexámico en ortopedia y traumatología

Introducción: En las dos últimas décadas se han incrementado las publicaciones sobre el empleo del ácido tranexámico en diferentes especialidades quirúrgicas; entre ellas, la cirugía ortopédica y traumatológica. Objetivo: Demostrar la importancia del ácido tranexámico en la cirugía electiva y de urgencia en ortopedia y traumatología. Desarrollo: Se revisaron las bases de datos Pubmed/Medline, SciELO, BVS, Scopus, Ebsco y Cochrane. Se emplearon los descriptores "ácido tranexámico", "reducción del sangrado posoperatorio en ortopedia", "pérdida de sangre", "agentes hemostáticos", "riesgo de transfusión" y "manejo del politraumatizado". Fueron incluidos artículos originales de investigación, de revisión, guías terapéuticas, metaanálisis y editoriales. Conclusiones: Aunque algunos autores divergen en cuanto a la dosis adecuada de ácido tranexámico en ortopedia y traumatología, todos concluyen que este producto controla el sangrado en situaciones traumáticas y en cirugías electivas o de urgencia.

Introduction: Currently, publications on the use of tranexamic acid in different surgical specialties have increased; among them, orthopedic and trauma surgery. Objective: To validate the importance of tranexamic acid in elective and emergency surgery in orthopedics and traumatology. Discussion: Pubmed/Medline, SciELO, VHL, Scopus, Ebsco and Cochrane databases were reviewed, using the descriptors "tranexamic acid", "reduction of postoperative bleeding in orthopedics", "blood loss", "hemostatic agents", "transfusion risk" and "management of multiple trauma patients". Conclusions: Although some authors diverge regarding the adequate dose of tranexamic acid in orthopedics and traumatology, all conclude that this product controls bleeding in traumatic situations and in elective or emergency surgeries.

The Effectiveness and Safety of Autologous Platelet Concentrates as Hemostatic Agents after Tooth Extraction in Patients on Anticoagulant Therapy: A Systematic Review of Randomized, Controlled Trials.

One of the common challenges in oral surgery is dealing with patients who are taking oral anticoagulant/antiaggregant drugs. Several local hemostatic agents have been proposed as an alternative to conventional suturing. Among these, autologous platelet concentrates (APCs) have been widely used to decrease the risk of hemorrhage after dental extraction. Nevertheless, there is a lack of consensus regarding the superiority of any one specific hemostatic agent over the others. This systematic review is aimed at evaluating the effectiveness of APCs as hemostatic agents after tooth extraction in patients on anticoagulant therapy. A literature search was conducted of articles published before March 2023 on PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL). Studies on the use of APCs in patients undergoing dental extractions and being treated with anticoagulant drugs were included. Only randomized, controlled trials (RCTs) published up to March 2023 were included; the outcomes assessed were the time to hemostasis, the presence of post-operative bleeding and pain, and the effectiveness of wound healing. The risk of bias for each RCT was assessed by using the 'risk of bias' tool (RoB 1.0). The research revealed 6 RCTs. The findings indicated that patients on anticoagulant therapy who received APCs without discontinuing their medication experienced a decreased post-operative bleeding, a shorter hemostasis time, reduced pain, and accelerated wound healing. However, due to the high/unclear risk of bias of the studies included, no definitive conclusions can be drawn on the superiority of APCs as hemostatic agents over other similar products. Additional studies are required to validate these findings.

A contemporary systematic review of the complications associated with SURGICEL.

BACKGROUND: This review aims to summarize the findings from recent literature (2010-2022) reporting on complications that resulted from the surgical use of SURGICEL for intraoperative hemostasis. METHODS: A literature search was conducted using the MEDLINE (OVID), Embase, and Cochrane Central Register of Controlled Trials - CENTRAL (OVID) databases. The studies were sorted into case reports and other study types for data extraction. Covidence was used for data extraction and statistics were descriptive. RESULTS: Of the total 560 articles screened, 73 papers were selected for a full-text review and 70 studies were included in this review. A total of 7,242 participants were included in the studies (case studies n = 93, others n = 7149). 67/70 of the included studies reported complications when SURGICEL was used intraoperatively. Reported complications included: SURGICEL induced masses (granulomas, abscesses, hematomas, cysts) (n = 25), hemorrhagic complications (n = 12), masses misdiagnosed as tumors, cardiovascular, nervous system, and hepatobiliary complications, pain, and infections. Other complications included: fistulas, erectile dysfunction, chorioamnionitis, swelling, urinary leak, renal failure, and anaphylaxis. CONCLUSIONS: Publications reporting on complications associated with the use of SURGICEL intraoperatively have continued to emerge. Future studies should compare how the types and rates of complications compare between SURGICEL and alternative hemostatic agents.

Methods of Hemostasis in Cranial Neurosurgery: An Anatomy-Based Stepwise Review.

BACKGROUND: Hemostasis is crucial in preventing hemorrhage during cranial neurosurgical procedures and maintaining visualization of the surgical field. There is significant variation in the availability of hemostatic methods across different settings and hemostatic techniques are being continuously developed over the decades of practicing neurosurgery. The aim of this article is to provide an outline of the potential methods to achieve hemostasis based on the sequential operative anatomy of a cranial operation. METHODS: A systematic review was conducted following the PRISMA guidelines. The PubMed database was searched from inception of the database to July 18, 2023. A total of 64 studies were identified fulfilling predefined inclusion criteria, and the risk of bias was assessed using the Joanna Briggs Institute checklists. RESULTS: Seventy-one hemostatic agents, techniques, tools, and devices were identified, which were then categorized according to the operative phase for which they are indicated. Nine operative anatomic targets were addressed in the sequence in which they are involved during a cranial procedure. For each anatomic target, the following number of hemostatic techniques/agents were identified: 11 for scalp, 3 for periosteum, 10 for skull bone, 11 for dura mater, 9 for venous sinuses, 5 for arteries, 6 for veins, 12 for brain parenchyma, and 4 for cerebral ventricles. CONCLUSIONS: Depending on the phase of the surgery and the anatomic structure involved, the selection of the appropriate hemostatic method is determined by the source of bleeding. Surgeon awareness of all the potential techniques that can be applied to achieve hemostasis is paramount, especially when faced with operative nuances and difficult-to-control bleeding during cranial neurosurgical procedures.

Impact of Current Technology in Laparoscopic Adrenalectomy: 20 Years of Experience in the Treatment of 254 Consecutive Clinical Cases.

BACKGROUND: Laparoscopic adrenalectomy (LA), which avoids large abdomen incisions, is considered the gold standard technique for the treatment of benign small- and medium-size adrenal masses (<6 cm) and weighing < 100 g. A trascurable mortality and morbidity rate, short hospitalization and patient rapid recovery are the main advantages compared to traditional surgery. During the past decade, a new surgical technology has been developed that expedites a "clipless" adrenalectomy. Here, the authors analyze a clinical series of 254 consecutive patients who were affected by adrenal gland neoplasms and underwent LA by the transabdominal lateral approach over the two last decades. A literature review is also presented. METHODS: Preoperative, intraoperative and postoperative data from 254 patients who underwent LA between January 2003 and December 2022 were retrospectively collected and reviewed. Diagnosis was obtained on the basis of clinical examination, laboratory values and imaging techniques. Doxazosin was preoperatively administered in the case of pheochromocytoma (PCC) while spironolactone and potassium were employed to treat Conn's disease. The same surgeon (CG) performed all the LA and utilized the same laparoscopic transabdominal lateral approach. Different dissection tools-ultrasonic, bipolar or mixed scissors-and hemostatic agents were used during this period. The following results were obtained: 254 patients were included in the study; functioning tumors were diagnosed in 155 patients, 52 patients were affected by PCCs, 55 by Conn's disease, 48 by Cushing's disease. Surgery mean operative time was 137.33 min (range 100-180 min) during the learning curve adrenalectomies and 98.5 min (range 70-180) in subsequent procedures. Mean blood loss was respectively 160.2 mL (range 60-280) and 96.98 mL (range 50-280) in the first 30 procedures and the subsequent ones. Only three conversions (1.18%) to open surgery occurred. No mortality or postoperative major complications were observed, while minor complications occurred in 19 patients (3.54%). In 153 out of 155 functioning neoplasms, LA was effective in the normalization of the endocrine profile. According to our experience, a learning curve consisting of 30 cases was identified. In fact, a lower operative time and a lower complication rate was reported following 30 LA. CONCLUSIONS: LA is a safe procedure, even for masses larger than 6 cm and PCCs. Undoubtedly, the development of surgical technology has made it possible reducing operative times, performing a "clipless" adrenalectomy and extending the indications in the treatment of more complex patients. A multidisciplinary team, in referral high-volume centers, is recommended in the management of adrenal pathology. A 30-procedure learning curve is necessary to improve surgical outcomes.

Chitosan-Based Biomaterials for Hemostatic Applications: A Review of Recent Advances.

Hemorrhage is a detrimental event present in traumatic injury, surgery, and disorders of bleeding that can become life-threatening if not properly managed. Moreover, uncontrolled bleeding can complicate surgical interventions, altering the outcome of surgical procedures. Therefore, to reduce the risk of complications and decrease the risk of morbidity and mortality associated with hemorrhage, it is necessary to use an effective hemostatic agent that ensures the immediate control of bleeding. In recent years, there have been increasingly rapid advances in developing a novel generation of biomaterials with hemostatic properties. Nowadays, a wide array of topical hemostatic agents is available, including chitosan-based biomaterials that have shown outstanding properties such as antibacterial, antifungal, hemostatic, and analgesic activity in addition to their biocompatibility, biodegradability, and wound-healing effects. This review provides an analysis of chitosan-based hemostatic biomaterials and discusses the progress made in their performance, mechanism of action, efficacy, cost, and safety in recent years.

FLOSEAL Versus SURGIFLO in Lumbar Surgery: Similar Outcomes, Different Costs in a Matched Cohort Analysis.

OBJECTIVE: Flowable gelatin-based matrices with thrombin for hemostatic control are commercially available as Floseal (Baxter International Inc.) and Surgiflo (Ethicon Inc.). The objective of this study is to compare the rate of blood transfusions following the use of Floseal and Surgiflo in lumbar spine surgery. METHODS: Elective lumbar spine surgery patients between September 2019 and March 2021 were identified via CPT codes. Floseal 10 mL (N=102) and Surgiflo matrix 8 mL (N=108) cohorts excluded those younger than 18 years or those who underwent surgeries for infection, trauma, or tumor. The primary outcome was blood transfusion. Surgical complexity was controlled using the Surgical Invasiveness Index and Adult Spinal Deformity Invasiveness Score. The 1:1 propensity score matching was performed using demographic information, Surgical Invasiveness Index, Adult Spinal Deformity Invasiveness Score, and tranexamic acid use. RESULTS: A total of 77 Floseal patients were propensity score matched with 77 Surgiflo patients. There was no difference in the rate of blood transfusion (p=0.441). There was also no difference in operative time, estimated blood loss, or postoperative hemoglobin levels. The Surgiflo cohort used more units per surgery (p=0.004) and cost $102.45 more per surgery. Switching to Floseal saves $102,450 per year per 1000 surgeries. CONCLUSIONS: There was no difference in transfusion rates between using Floseal or Surgiflo for lumbar spine surgery. Surgiflo had higher usage per surgery and costs than Floseal.

US Evaluation of Topical Hemostatic Agents in Post-Thyroidectomy.

BACKGROUND: the aim of this study was to describe the ultrasound appearance of topical hemostatics after thyroidectomy. METHODS: we enrolled 84 patients who were undergoing thyroid surgery and were treated with two types of topical hemostats, 49 with an absorbable hemostat of oxidized regenerated cellulose (Oxitamp®) and 35 with a fibrin glue-based hemostat (Tisseel®). All patients were examined using B-mode ultrasound. RESULTS: In 39 patients of the first group (approximately 80%), a hemostatic residue was detected and in some cases confused with a native gland residue, or with cancer recurrence in oncological patients. No residue was detected in patients in the second group. The main ultrasound characteristics of the tampon were analyzed and arranged according to predefined patterns, and suggestions to recognize it and avoid wrong diagnoses were provided. A part of the group of patients with tampon residue was re-evaluated after 6-12 months, ensuring that the swab remained for months after the maximum resorption time declared by the manufacturer. CONCLUSIONS: with equal hemostatic effectiveness, the fibrin glue pad is more favorable in the ultrasound follow-up because it creates reduced surgical outcomes. It is also important to know and recognize the ultrasound characteristics of oxidized cellulose-based hemostats in order to reduce the number of diagnostic errors and inappropriate diagnostic investigations.

Hemostatic Agents in Orthopedic Surgery.

Controlling blood loss is a crucial aspect of orthopedic surgery. Hemostatic agents can be used intraoperatively in combination with antifibrinolytics as part of an overall strategy to limit blood loss. Several new hemostatic agents have recently come to the market designed specifically for vascular surgery but have found uses in other surgical fields, including orthopedics. This article reviews the mechanisms of action and best uses of various mechanical hemostats, active hemostats, flowable hemostats, and fibrin sealants for achieving hemostasis in orthopedic surgery. Mechanical and active hemostats have been reported to successfully decrease blood loss from cancellous bone, capillaries, and venules. Flowable hemostats are generally favorable for use in small spaces where the swelling capabilities of mechanical and active hemostats can be detrimental to surrounding structures. Sealants are best used for closing defects in tissues.

The Use of PuraStat® in the Management of Walled-Off Pancreatic Necrosis Drained Using Lumen-Apposing Metal Stents: A Case Series.

Background and Objectives: Bleeding is one of the most feared and frequent adverse events in the case of EUS-guided drainage of WOPN using lumen-apposing metal stents (LAMSs) and of direct endoscopic necrosectomy (DEN). When it occurs, its management is still controversial. In the last few years, PuraStat, a novel hemostatic peptide gel has been introduced, expanding the toolbox of the endoscopic hemostatic agents. The aim of this case series was to evaluate the safety and efficacy of PuraStat in preventing and controlling bleeding of WOPN drainage using LAMSs. Materials and Methods: This is a multicenter, retrospective pilot study from three high-volume centers in Italy, including all consecutive patients treated with the novel hemostatic peptide gel after LAMSs placement for the drainage of symptomatic WOPN between 2019 and 2022. Results: A total of 10 patients were included. All patients underwent at least one session of DEN. Technical success of PuraStat was achieved in 100% of patients. In seven cases PuraStat was placed for post-DEN bleeding prevention, with one patient experiencing bleeding after DEN. In three cases, on the other hand, PuraStat was placed to manage active bleeding: two cases of oozing were successfully controlled with gel application, and a massive spurting from a retroperitoneal vessel required subsequent angiography. No re-bleeding occurred. No PuraStat-related adverse events were reported. Conclusions: This novel peptide gel could represent a promising hemostatic device, both in preventing and managing active bleeding after EUS-guided drainage of WON. Further prospective studies are needed to confirm its efficacy.

The use of sealing hemostat patch (HEMOPATCH®) in laparotomic myomectomy: a prospective case-control study.

PURPOSE: Uterine myomas are the most common gynecological disease. In these cases, a myomectomy is performed traditionally laparotomically. However, alternatives have been widely used, including laparoscopic, endoscopic, and robotic surgery. During these techniques, diffuse parenchymatous bleeding remains one of the main intraoperative and postoperative complications and sometimes requires unplanned hysterectomies. Recently, hemostatic agents and sealants have been used to prevent excessive blood loss during surgical repair. METHODS: We propose a prospective case-control study on the use of a sealing hemostat patch (HEMOPATCH®) on uterine sutures in laparotomic myomectomy. In the period between July 2016 and April 2017, 46 patients with symptomatic uterine fibromatosis underwent surgery. They were divided into two groups of 23 patients, with different treatments in the hemostatic phase of oozing bleeding. HEMOPATCH® is applied in group A, and spray electrocoagulation is applied in group B. RESULTS: In group A, we achieve faster hemostasis (p < 0.05), than in group B. We report a significantly lower C-reactive protein value on the second and third days after surgery for group A compared to group B. CONCLUSIONS: HEMOPATCH®, during laparotomic myomectomy, is a valid alternative solution for obtaining rapid hemostasis and consequently intraoperative and postoperative bleeding. Furthermore, we suggest that a lower inflammatory peritoneal state is probably correlated with the barrier effect of the patch on the suture.

Systemic hemostatic agents initiated in trauma patients in the pre-hospital setting: a systematic review.

PURPOSE: The effect of systemic hemostatic agents initiated during pre-hospital care of severely injured patients with ongoing bleeding or traumatic brain injury (TBI) remains controversial. A systematic review and meta-analysis was therefore conducted to assess the effectiveness and safety of systemic hemostatic agents as an adjunctive therapy in people with major trauma and hemorrhage or TBI in the context of developing the Italian National Institute of Health guidelines on major trauma integrated management. METHODS: PubMed, Embase, and Cochrane Library databases were searched up to October 2021 for studies that investigated pre-hospital initiated treatment with systemic hemostatic agents. The certainty of evidence was evaluated with the Grading of Recommendations Assessment, Development, and Evaluation approach, and the quality of each study was determined with the Cochrane risk-of-bias tool. The primary outcome was overall mortality, and secondary outcomes included cause-specific mortality, health-related quality of life, any adverse effects and blood product use, hemorrhage expansion, and patient-reported outcomes. RESULTS: Five trials of tranexamic acid (TXA) met the inclusion criteria for this meta-analysis. With a high certainty of evidence, when compared to placebo TXA reduced mortality at 24 h (relative risk = 0.83, 95% confidence interval = 0.73-0.94) and at 1 month among trauma patients (0.91, 0.85-0.97). These results depend on the subgroup of patients with significant hemorrhage because in the subgroup of TBI there are no difference between TXA and placebo. TXA also reduced bleeding death and multiple organ failure whereas no difference in health-related quality of life. CONCLUSION: Balancing benefits and harms, TXA initiated in the pre-hospital setting can be used for patients experiencing major trauma with significant hemorrhage since it reduces the risk of mortality at 24 h and one month with no difference in terms of adverse effects when compared to placebo. Considering the subgroup of severe TBI, no difference in mortality rate was found at 24 h and one month. These results highlight the need to conduct future studies to investigate the role of other systemic hemostatic agents in the pre-hospital settings.