Hemostatic Devices Research Articles

146 Safety and Effectiveness of a Kaolin-Impregnated Hemostatic Device in Anticoagulated Patients: Real-World and Controlled Trial Outcomes

146 Safety and Effectiveness of a Kaolin-Impregnated Hemostatic Device in Anticoagulated Patients: Real-World and Controlled Trial Outcomes

Enhanced specific surface area and mechanical property of silk nanofibers aerogel for potential hemostasis applications

Biopolymer aerogel is a new type of material with potential applications in the biomedical field. Silk fibroin is of particular interest as a raw material with good biocompatibility and degradable. However, the low mechanical strength and small specific surface area of silk fibroin aerogels limit its further development. Herein, a fast water absorption, highly specific surface area and mechanically strong of aerogels were prepared using low crystal silk fibroin nanofibers (SNF), sol-gel process, solvent exchange and supercritical carbon dioxide (CO2) drying method. The resulting Aero-Sc displayed highly specific surface area (251 m2/g), porosity (97.6 %) and water absorption capacity (1200 %). Furthermore, with rapid water absorption and stronger erythrocyte adhesion, the Aero-Sc showed highly effective hemostasis in vitro. In vivo, animal experiments on rat liver hemorrhage model confirmed that SNF aerogels have a less blood loss (312 ± 29 mg) and faster hemostatic time (92 ± 13 s) than commercially gelatin sponge (p < 0.05). The unique properties of silk fibroin nanofibers aerogel developed in this study has great potential to be a safe and effective hemostatic medical device.

Rapid haemostasis to achieve dressing longevity: evaluation trial results using StatSeal catheter exit site protection.

Peripherally inserted central catheters (PICCs) are vital in delivering intravenous therapy. Despite their advantages, PICCs can lead to complications such as catheter exit site bleeding, which can cause patient distress and increase infection risk. This study evaluated the efficacy of StatSeal, a topical haemostatic device, in managing PICC exit site bleeding. StatSeal uses a hydrophilic polymer and potassium ferrate to form a seal, reducing access site bleeding and minimising dressing changes. For this study, Patients were recruited at Frimley Health NHS Foundation Trust; the trial involved 177 patients with StatSeal, and shows that 99% did not require additional dressing changes within the standard 7-day period. The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, enhancing the efficiency of vascular access maintenance and potentially lowering associated healthcare costs. The trial emphasises the importance of innovative solutions such as StatSeal to advance PICC care and improve patient experience.

Improving Operating Room Efficiency in Otolaryngology-Head and Neck Surgery: A Scoping Review.

One minute of operating room (OR) time costs $36 to 37. However, ORs are notoriously inefficient. There is growing literature on improving OR efficiency, but no formal review of this topic within otolaryngology has been performed. This study reviews and synthesizes the current literature on improving OR efficiency within otolaryngology. MEDLINE, EMBASE, Web of Science, CINAHL, Cochrane Library, preprints.org, and medRxiv were searched on November 4, 2022. Published English studies were included if they reported on metrics for improving OR efficiency within otolaryngology. There were no publication date restrictions. Articles were screened by 2 reviewers. Preferred Reporting Items for Systematic Reviews and Meta-analysis reporting for scoping reviews was followed. The search yielded 9316 no-duplicate articles; 129 articles were included. Most of the studies reported on head and neck procedures (n = 52/129). The main tactics included surgical considerations: hemostatic devices, techniques, and team/simultaneous approaches; anesthetic considerations: local anesthetic and laryngeal mask airways; procedure location considerations: procedures outside of the OR and remote technologies; standardization: equipment, checklists, and personnel; scheduling considerations: use of machine learning for booking, considering patient/surgeon factors, and utilizing dedicated OR time/multidisciplinary teams for on-call cases. The current literature brings to attention numerous strategies for improving OR efficiency within otolaryngology. Applying these strategies and implementing novel techniques to manage surgical cases may assist in offloading overloaded health care systems and improving access to care while facilitating patient safety and outcomes. Anticipated barriers to implementation include resistance to change, funding, and the current strain on health care systems and providers.

State of art of robotic prostatectomy: the way we do it in Catalonia, Spain

Introduction and objectiveRobotic-assisted laparoscopic prostatectomy (PLAR) seems to improve functional outcomes, however there is not a consensus of a standard procedure. The aim of this study was to identify the PLAR “state of art” in Catalonia, Spain. Material and methodsThis was a cross-sectional survey-based study conducted among urologists across Catalonia, Spain. The survey was distributed through online platforms and the professional urology society. All statistical analyses were performed using Stata software, v20. Results59 urologists completed the survey, revealing PLAR as the most commonly used technique (79.7%). Most urologist (70%) create the pneumoperitoneum using a controlled incision with direct access and 78.3% use the Airseal technology. The intraperitoneal approach is performed in >90% of cases. Endopelvic fascia preservation is not routinely performed. 34.5% of the survey not perform the dorsal vein complex suture. All preserves the bladder neck when oncologically safe. Nerve-vascular bundles bleeding control is performed using standard coagulation or suturing. 34% performed posterior reconstruction. Only use hemostatic devices when evident bleeding and 70% does not routinely left a drainage.Multivariable analysis showed that center volume had a significant independent association with dorsal venous complex suturing (OR 0.073, 95%CI 0.07−0.826), nerve-vascular bundles suturing hemostasis (OR 11.67, 95%CI 1.07−127.60) and endopelvic fascia preservation (OR 13.64, 95%CI 1.087–201.27), but there was no correlation with time the bladder catheter or days hospitalized. ConclusionsThe study provides an overview of the state of PLAR in Catalonia, Spain, showing significant variability and reflecting a commitment to advancing surgical technology and patient care.

Los últimos avances en prostatectomía robótica: ¿cómo lo hacemos en Cataluña, España?

Introduction and objectiveRobotic-assisted laparoscopic prostatectomy (RALP) seems to improve functional outcomes, however there is not a consensus of a standard procedure. The aim of this study was to identify the RALP “state of art” in Catalonia, Spain. Material and methodsThis was a cross-sectional survey-based study conducted among urologists across Catalonia. The survey was distributed through online platforms and the professional urology society. All statistical analyses were performed using Stata software, v. 20. ResultsFifty-nine urologists completed the survey, revealing RALP as the most commonly used technique (79.7%). Most urologist (70%) create the pneumoperitoneum using a controlled incision with direct access and 78.3% use the AirSeal® technology. The intraperitoneal approach is performed in more than 90% of cases. Endopelvic fascia preservation is not routinely performed. A percentage of 34.5 of the survey not perform the dorsal vein complex suture. All preserves the bladder neck when oncologically safe. Nerve-vascular bundles bleeding control is performed using standard coagulation or suturing. Thirty-four percent performed posterior reconstruction. Only use hemostatic devices when evident bleeding and 70% does not routinely left a drainage. Multivariable analysis showed that center volume had a significant independent association with dorsal venous complex suturing (OR 0.073, 95% CI 0.07-0.826), nerve-vascular bundles suturing hemostasis (OR 11.67, 95% CI 1.07-127.60) and endopelvic fascia preservation (OR 13.64, 95% CI 1.087-201.27), but there was no correlation with time the bladder catheter or days hospitalized. ConclusionsThe study provides an overview of the state of RALP in Catalonia, Spain, showing significant variability and reflecting a commitment to advancing surgical technology and patient care.

Design and application of distal radial artery hemostat

Transradial approach is the classical access for coronary angiography and percutaneous coronary intervention (PCI). With the increase in the number of interventional procedures, some disadvantages of the transradial approach have also been found, it is easy to lead to various complications, such as radial artery occlusion, radial nerve injury, and puncture difficulties after radial artery spasm. Therefore, some experts put forward the approach of distal radial artery approach for interventional therapy, which has the advantages of convenient positioning, easy postoperative hemostasis, less damage to the proximal radial artery and improving patients' comfort. However, there is no special distal radial artery hemostat in clinic, which limits the development of this approach to a certain extent. Therefore, based on the principles of anatomy and physics, cardiovascular physician at Jiading District District Central Hospital in Shanghai designed and invented a distal radial artery hemostatic device, which is convenient for clinical hemostasis of distal radial artery puncture, and obtained the National Utility Model Patent (patent number: ZL 2021 2 2097829.6). The hemostatic device consists of a glove body with a silicone gasket protruding towards the skin on the inner surface and a binding component. The patient's hand is inserted into the glove body, and after being fixed by the restraint component, the silicone gasket can effectively compress the location of the radial artery puncture point, and play a good hemostatic effect with less pressure, avoid the common complications of proximal radial artery hemostatic, and reduce the discomfort of the patient. Has good application value.

An architecturally rational hemostat for rapid stopping of massive bleeding on anticoagulation therapy

Hemostatic devices are critical for managing emergent severe bleeding. With the increased use of anticoagulant therapy, there is a need for next-generation hemostats. We rationalized that a hemostat with an architecture designed to increase contact with blood, and engineered from a material that activates a distinct and undrugged coagulation pathway can address the emerging need. Inspired by lung alveolar architecture, here, we describe the engineering of a next-generation single-phase chitosan hemostat with a tortuous spherical microporous design that enables rapid blood absorption and concentrated platelets and fibrin microthrombi in localized regions, a phenomenon less observed with other classical hemostats without structural optimization. The interaction between blood components and the porous hemostat was further amplified based on the charged surface of chitosan. Contrary to the dogma that chitosan does not directly affect physiological clotting mechanism, the hemostat induced coagulation via a direct activation of platelet Toll-like receptor 2. Our engineered porous hemostat effectively stopped the bleeding from murine liver wounds, swine liver and carotid artery injuries, and the human radial artery puncture site within a few minutes with significantly reduced blood loss, even under the anticoagulant treatment. The integration of engineering design principles with an understanding of the molecular mechanisms can lead to hemostats with improved functions to address emerging medical needs.

Transbronchial cryobiopsy using an ultrathin cryoprobe with a guide sheath for the diagnosis of pulmonary mucosa-associated lymphoid tissue lymphoma.

Pulmonary mucosa-associated lymphoid tissue (MALT) lymphoma is difficult to diagnose and relatively rare. Tissue sampling through transbronchial biopsy is often inadequate, necessitating surgical lung biopsy. However, a recently developed technique, transbronchial lung cryobiopsy (TBLC), has shown promise for obtaining larger specimens. A 1.1 mm cryoprobe has recently become available, and its usefulness has been increasingly reported. Use of a conventional cryoprobe for TBLC in diagnosing pulmonary MALT lymphoma has been previously reported; however, there are no reports on the use of a 1.1 mm ultrathin cryoprobe and guide sheath (GS). We aimed to assess the effectiveness and safety of using a 1.1 mm ultrathin cryoprobe in combination with a GS for diagnosing pulmonary MALT lymphoma using a simpler and safer method. We retrospectively analyzed the findings for four patients showing characteristic computed tomography (CT) findings of MALT lymphoma, including peripheral pulmonary lesions, air bronchogram nodules, and bronchiectasis, at our hospital. Each patient underwent endobronchial ultrasound (EBUS) with a GS, followed by TBLC using a 1.1 mm cryoprobe. Morphological diagnosis, immunohistochemical examination, and molecular testing were performed on the biopsy specimens to establish the diagnosis. Complications during the procedure were also monitored. We obtained 8-16 biopsy specimens in all four cases using a cryoprobe. Histopathological analysis of two cases revealed the infiltration of small lymphocytes with numerous lymphoepithelial lesions, confirming MALT lymphoma. Immunohistochemical examination further demonstrated B-cell lymphocyte proliferation and light-chain restriction, confirming monoclonality and providing a definitive diagnosis. In the remaining two cases, histopathological evidence of pulmonary MALT lymphoma was lacking. However, molecular testing using polymerase chain reaction to analyze immunoglobulin gene rearrangements revealed B-cell clonality, which supported the diagnosis. Molecular testing proved particularly useful when histopathological diagnosis alone was inconclusive. No complications such as pneumothorax or hemorrhage occurred during the procedure. The combination of a GS and EBUS facilitated specimen collection at the same location as EBUS, with the GS providing compression hemostasis and eliminating the need for an additional hemostatic device. Therefore, TBLC with a GS is a useful and safe method for diagnosing pulmonary MALT lymphomas and reproducibly yielded sufficient quantities of good-quality biopsy specimens.

Polyphosphate-loaded silk fibroin membrane as hemostatic agent in oral surgery: a pilot study

PurposePost-interventional hemorrhage can result in serious complications, especially in patients with hemostatic disorders. Identification of safe and efficient local hemostatic agents is important, particularly in the context of an ageing society and the emergence of new oral anticoagulants. The aim of this in vitro study was to investigate the potential of silk fibroin membranes coated with the inorganic polymer polyphosphate (polyP) as a novel hemostatic device in oral surgery.MethodsCocoons of the silkworm Bombyx mori were degummed and dissolved. Varying amounts of long-chain polyP (2–2000 µg/mm2) were adsorbed to the surface of silk fibroin membranes. Analysis of the procoagulant effect of polyP-coated silk membranes was performed using real-time thrombin generation assays in human plasma. Increasing concentrations of polyP (0.15–500 µg/ml) served as a positive control, while uncoated silk fibroin membranes were used as negative control.ResultsPolyP-coated silk fibroin membranes triggered coagulation when compared to plasma samples and pure silk fibroin membranes. A polyP-dose-dependent effect of thrombin generation could be found with a maximum (ETP = 1525.7 nM⋅min, peak thrombin = 310.1 nM, time to peak = 9.8 min, lag time = 7.6 min.) at 200 µg/mm2 of polymer loading on the silk fibroin membrane surface.ConclusionsIn this study, it was demonstrated that silk fibroin membranes coated with polyP have the potential to act as a promising novel hemostatic device.Graphical

Platelet reactivity and activated clotting time predict haemorrhagic site complications in patients with chronic coronary syndromes undergoing percutaneous coronary intervention

Abstract Background/Introduction Same-day discharge has become a standard of care for patients with chronic coronary syndromes (CCS) treated with ad hoc percutaneous coronary interventions (PCI). QuickClot Radial kaolin-based haemostatic device may shorten haemostasis time and reduce the incidence of vascular site complications. Besides unfractionated heparin (UFH) and aspirin (ASA), an ad hoc procedure demands a loading dose of clopidogrel. Dynamic changes in platelets and thrombotic activity may influence the outcomes at vascular sites. Rapid "point-of-care" testing measures the effects of anticoagulation but the optimal threshold during and after PCI still requires further research. Purpose We investigated the effect of a standard dose of UFH and a loading dose of clopidogrel measured with point-of-care devices: Hemochron activated clotting time device (ACT), VerifyNow P2Y12 test on on-site outcomes. Methods We conducted a prospective, observational study of consecutive patients with CCS who qualified for ad hoc PCI. Patients were on chronic ASA therapy, received 100 IU/kg UFH, and a 600 mg loading dose of clopidogrel. ACT was measured before and 10 min, 2 h, and 6 h after the administration of UFH and clopidogrel, respectively, and the VerifyNow P2Y12 test measured after 2 and 6 h. A QuickClot haemostatic pad with gradually released compression for up to 2 h was used in all patients. Ultrasonographic assessment of artery diameter and patency was performed before and 6 h after the procedure. Bleeding (BARC criteria) or local haematoma (EASY scale) were observed regularly until hospital discharge. Results Forty patients were enrolled in the study. The mean±SD age was 68.8±8.8 years, 30 (75%) patients were men, 13 (35%) had diabetes, 38 (95%) hypertension, 16 (40%) previous myocardial infarction, and 15 (37,5%) were active smokers. Patients received a median [interquartile range (IQR)] 8000 [7000-9000] IU of UFH and 600 mg of clopidogrel. All of the radial arteries remained patent during observation; local bleeding (BARC 2) was observed in 11 (27,5%) and haematomas (EASY 1 and 2) in 11 (27,5%) patients. Patients with bleeding had lower platelet activity measured with platelet reactivity units (PRU) after 2 h (122.5± 51 vs 158.7± 43, p= 0.04) and higher ACT (s) (216.9 ±40 vs. 184.6±28 s, p=0.006). An ACT &amp;gt;196 s, measured 2 h after the procedure, predicted the occurrence of bleeding or haematoma (AUC 0.72; 95%CI 0.56-0.85, p=0.008). Conclusion Lower platelet activity and higher ACT after PCI were associated with higher risk of haemorrhagic site complications. "Point-of-care" measures post PCI in CCS patients may be clinically applicable.

Conventional versus facilitated hemostatic dressings after radial artery puncture: a systematic review and meta-analysis

Abstract In the last thirty years, transradial access (TRA) became the gold standard access site for minimal invasive coronary diagnostics and therapy. Though the complication rate is relatively low, TRA is frequently iterated, therefore the slightest improvement could be utmost beneficial for a big proportion of cardiology patients. In recent few years, facilitated hemostatic dressings with the utilisation of chitosan and potassium ferrate molecules were introduced into the clinical practice to improve postprocedural hemostasis. The available evidence suggests that the novel dressings are decreasing complication numbers, but currently no coherent meta-analysis is available on the subject. We hypothesised that better clinical outcomes can be expected with the novel facilitated hemostatic dressings in terms of radial artery occlusion, radial artery damage, time to hemostasis and hematoma events compared to conventional mechanical compression devices. A systematic search was performed in Medline, Central Web of Science, Scopus and Embase on 13th January, 2023. Randomised controlled trials comparing chitosan and potassium-ferrate covered dressings to pneumatic or screwable mechanical compression devices. Observational studies, trials not reporting outcomes or containing scientifically unproven devices were excluded. The RoB 2 tool was used for risk of bias assessment, which was low across the included studies. As primary endpoint, radial artery occlusion (RAO) was determined, the secondary endpoints were hematoma events, time to hemostasis and radial artery damage (dissection, pseudoaneurysm). Raw data from the selected studies were pooled using a random effects model with the Mantel-Haenszel method and the Hartung-Knapp adjustment. Statistical heterogeneity across trials was assessed by means of Cochrane Q test, and the I2 values. Data of a total of 3524 patients were collected from 7 randomised controlled trials. Concerning the primary endpoint, RAO, a 0.70 relative risk (RR) was found (p=0.028, confidence interval (CI): 0.52-0.95) in favour of the facilitated hemostatic devices. In the chitosan subgroup a lower tendency of RAO in the facilitated group (RR: 0.66 p=0.059 CI: 0.42-1.03) was found. In the potassium ferrate subgroup no significant difference was observed between the devices (RR: 0.93 p=0.819 CI: 0.27-3.20). Low grade (EASY I/II) hematoma events were not significantly different between the two examined groups (RR: 0.76 p=0.268 CI: 0.43-1.32). Time to hemostasis was 95.8 (mean difference, p≺0.001 CI: 46.8-144.9) minutes shorter in the facilitated devices group from 5 studies containing 2132 patient’s data. This meta-analysis includes the largest number of patients for facilitated hemostatic dressings to date. These devices lower the incidence of RAO by 30% compared to mechanical compression devices with the additional advantage of reduced compression times. More randomised controlled clinical trials are needed in the subject.

Endoscopic Management of Bleeding in Altered Anatomy after Upper Gastrointestinal Surgery.

Postoperative non variceal upper gastrointestinal haemorrhage may occur early or late and affect a variable percentage of patients-up to about 2%. Most cases of intraluminal bleeding are an indication for urgent Esophagogastroduodenoscopy (EGD) and require endoscopic haemostatic treatment. In addition to the approach usually adopted in non-variceal upper haemorrhages, these cases may be burdened with difficulties in terms of anastomotic tissue, angled positions, and the risk of further complications. There is also extreme variability related to the type of surgery performed, in the context of oncological disease or bariatric surgery. At the same time, the world of haemostatic devices available in digestive endoscopy is increasing, meeting high efficacy rates and attempting to treat even the most complex cases. Our narrative review summarises the current evidence in terms of different approaches to endoscopic haemostasis in upper bleeding in altered anatomy after surgery, proposing an up-to-date guidance for endoscopic clinicians and at the same time, highlighting areas of future scientific research.

Safety and Efficacy of a Novel Compression Hemostatic Device for Vascular Access: A Quality Improvement Study

Safety and Efficacy of a Novel Compression Hemostatic Device for Vascular Access: A Quality Improvement Study

Evaluation of hemostatic devices in a randomized porcine model of junctional hemorrhage and 72-hour prolonged field care.

Hemorrhage control in prolonged field care (PFC) presents unique challenges that drive the need for enhanced point of injury treatment capabilities to maintain patient stability beyond the Golden Hour. To address this, two hemostatic agents, Combat Gauze (CG) and XSTAT, were evaluated in a porcine model of uncontrolled junctional hemorrhage for speed of deployment and hemostatic efficacy over 72 hours. The left subclavian artery and subscapular vein were isolated in anesthetized male Yorkshire swine (70-85 kg) and injured via 50% transection, followed by 30 seconds of hemorrhage. Combat Gauze (n = 6) or XSTAT (n = 6) was administered until bleeding stopped and remained within subjects for observation over 72 hours. Physiologic monitoring, hemostatic efficacy, and hematological parameters were measured throughout the protocol. Gross necropsy and histology were performed following humane euthanasia. Both CG and XSTAT maintained hemostasis throughout the full duration of the protocol. There were no significant differences between groups in hemorrhage volume (CG: 1021.0 ± 183.7 mL vs. XSTAT: 968.2 ± 243.3 mL), total blood loss (CG: 20.8 ± 2.7% vs. XSTAT: 20.1 ± 5.1%), or devices used (CG: 3.8 ± 1.2 vs. XSTAT: 5.3 ± 1.4). XSTAT absorbed significantly more blood than CG (CG: 199.5 ± 50.3 mL vs. XSTAT: 327.6 ± 71.4 mL) and was significantly faster to administer (CG: 3.4 ± 1.6 minutes vs. XSTAT: 1.4 ± 0.5 minutes). There were no significant changes in activated clot time, prothrombin time, or international normalized ratio between groups or compared with baseline throughout the 72-hour protocol. Histopathology revealed no evidence of microthromboemboli or disseminated coagulopathies across evaluated tissues in either group. Combat Gauze and XSTAT demonstrated equivalent hemostatic ability through 72 hours, with no overt evidence of coagulopathies from prolonged indwelling. In addition, XSTAT offered significantly faster administration and the ability to absorb more blood. Taken together, XSTAT offers logistical and efficiency advantages over CG for immediate control of junctional noncompressible hemorrhage, particularly in a tactical environment. In addition, extension of indicated timelines to 72 hours allows translation to PFC.

OBSERVATIONAL STUDY OF COSTS AND APPROPRIATENESS OF USE OF HEMOSTATIC DEVICES AND DRUGS IN DIFFERENT TYPES OF BLEEDING

OBSERVATIONAL STUDY OF COSTS AND APPROPRIATENESS OF USE OF HEMOSTATIC DEVICES AND DRUGS IN DIFFERENT TYPES OF BLEEDING

A Novel Hemostatic Belt Allowing Ambulation Soon After Atrial Fibrillation Ablation.

We aimed to develop a hemostatic device with physiological evidence that allows ambulation soon after atrial fibrillation (AF) ablation. We measured right femoral vein pressure in 57 participants to clarify why groin post-venipuncture rebleeding often occurs during the transition from supine to sitting under compression bandage application and found that it increased more than threefold when raising the upper body (8.6 ± 4.1 to 27.6 ± 6.9 mmHg; P < 0.001). Based on that data, we created a novel hemostatic belt. Its capability test including 25 participants demonstrated that the belt gave much higher compression pressures on the right groin while sitting than the compression bandage (59.5 ± 14.9 vs. 8.1 ± 4 mmHg; P < 0.001), achieving pressures above the maximum femoral vein pressure in 92% of participants. A randomized trial comparing the belt with compression bandage in 74 AF patients demonstrated that the belt reduced time to ambulation without any rebleeding (340 [92.5-360] vs. 360 [360-360] min; P < 0.001) and satisfied more patients. The novel hemostatic belt provided a much higher compression pressure on the right groin during the sitting position than the conventional compression bandage, achieving a pressure above the maximum femoral vein pressure in 92% of the participants.

Development and application of a spray tip that enables electrocoagulation of a variety of tissues

BackgroundSpray hemostasis is possible using a high-frequency power source from the tip of an electric scalpel; however, the difficulties regarding the uniformity and rapidity of the hemostasis surface remain. This study reports the development of a novel electrocoagulation device tip that can be used in endoscopic and robotic surgeries and can quickly coagulate and hemostat and easily adjust the extent of cauterization and hemostasis while minimizing the depth of thermal injury. MethodsThe safety and efficacy of the hemostatic device were verified in a porcine model. A liver surface transection was conducted in vivo and the rapidity of the hemostatic effect of the device was observed. An extracted stomach, kidney, and liver were cauterized ex vivo by three operators with different surgical skills and the effects were analyzed pathologically. In addition, a sacrificed pig cadaver was used to achieve hemostasis at a renal transection site using the multi-spray endoscope tip. ResultsAn increase in the number of tip terminals expanded the cauterization surface and shortened the cauterization time. In parenchymatous organs, uniform cauterization was possible without increasing the depth of thermal injury. The cauterization depth did not depend on the operator's skill, and the spray coagulation was safe. The variable spray tip allowed for simple hemostasis during open and laparoscopic surgeries. ConclusionsThis novel electrocoagulation device tip can be developed as a forceps that can change the spray range and can be used during laparoscopic and robotic surgeries.

Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial

IntroductionIn metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG).MethodsIn this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality.ResultsIn total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien–Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported.ConclusionThis study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications.Graphical abstract

A «Push&amp;Plug» Lifesaving Device to Prevent Exsanguination

Introduction:Severe bleeding from external wounds is a major reason for death. Immediate control of hemorrhage is of highest priority. We present the novel Acute Wound Occluder (AWO) which was developed for rapid and targeted wound occlusion. Here, we present the design, in-vitro testing, and in-vivo performance compared to QuikClot® using a clinically-relevant pig model.Method:AWO is made of an applicator with pushing function into which a self-expanding, Silicone coated Nitinol meshgraft is mounted to enable plugging into the wound-channel. In-vitro tests included biocompatibility, cytotoxicity, skin sensitization, and aging validation. Next, 12 pigs underwent standardized sized femoral-artery puncture to mimic life-threatening bleeding and were either treated with the AWO (n=6) or QuikClot® (control). Animals were followed-up for 4hrs, before device-removal macroscopic assessment.Results:The AWO successfully passed all in-vitro tests. The AWO could be delivered within 40±15 seconds to the wound to achieve instant bleeding control, and no additional manual compression needed. Quick Clot application was less convenient, with approximately four minutes (application 56±8ss, plus three minutes of manual compression) to achieve bleeding control. In all AWO treated pigs, exsanguination could be prevented immediately, no major blood-pressure drops occurred, with four pigs where bleeding could be completely stopped, and two pigs with irrelevant oozing which stopped within 75-150 seconds leading to minimal blood-loss of 12ml and 2ml. Tissue-analysis showed only small hematomas in five out of six animals. In contrast, QuickClot treated pigs showed significant bleeding and a blood-loss of 19ml. All six pigs showed substantial hematomas, two out of six showed very large hematomas. AWO application appeared to be safe with no peri-procedural adverse-events (AEs) or collateral damage to surrounding tissues.Conclusion:The AWO enables rapid and targeted control of life-threatening bleeding without any AEs. The AWO may represent a promising hemostatic device for bullet or knife-stab wounds.