Evaluation of hemostatic efficacy and safety of oxidized regenerated cellulose (Pahacel®) in coronary bypass surgery.

OBJECTIVE: The aim of this study is to evaluate the efficacy and safety of oxidized regenerated cellulose (ORC) in patients who underwent coronary artery bypass grafting (CABG) surgery and to compare the results of patients in whom ORC was used or not used for control of bleeding. METHOD: Pre-, intra-, and post-operative demographic and medical parameters of the patients in whom ORC was used or not used were compared. Quantitative data were analyzed with mean and standard deviation. Group differences were assessed with the Mann-Whitney U test. RESULTS: It was found that the duration of surgery, average numbers of erythrocyte and fresh frozen plasma (FFP) transfusions during surgery, average post-operative FFP transfusion count, duration of intensive care unit stay, and chest tube removal times were lower in the ORC group compared to the control group, and all these differences were statistically significant (p < 0.05 for all of these parameters). CONCLUSIONS: The study successfully demonstrated the effective and safe use of topical ORC in controlling bleeding and preventing oozing during CABG surgeries.

OBJETIVO: Evaluar la eficacia y la seguridad de la celulosa regenerada oxidada (CRO) en pacientes sometidos a cirugía de injerto de derivación de arteria coronaria y comparar los resultados de los pacientes en los que se utilizó o no la CRO para el control del sangrado. MÉTODO: Se compararon los parámetros demográficos y médicos pre-, intra- y posoperatorios de los pacientes en los que se utilizó o no CRO. Los datos cuantitativos se analizaron con media y desviación estándar. Las diferencias grupales se evaluaron con la prueba U de Mann Whitney. RESULTADOS: Se encontró que la duración de la cirugía, el número promedio de transfusiones de eritrocitos y de plasma fresco congelado durante la cirugía, el recuento promedio de transfusiones de plasma fresco congelado posoperatorias, la duración de la estadía en la unidad de cuidados intensivos y los tiempos hasta la extracción del tubo torácico fueron menores en el grupo de CRO en comparación con el grupo control, y todas estas diferencias fueron estadísticamente significativas (p < 0.05). CONCLUSIONES: El estudio demostró con éxito el uso eficaz y seguro de la CRO tópica para controlar el sangrado y prevenir la supuración durante las cirugías de derivación de arteria coronaria.

Clinical evaluation of CoolSeal - a new, safe, and fast vessel sealing device in total thyroidectomy.

Objective. CoolSeal is a new vessel sealing system for dissection and hemostasis during surgery. No clinical studies have investigated safety, advantages or disadvantages regarding the use of this device. The aim of the present study was to investigate the safety of CoolSeal and compare it with conventional ligation technique or LigaSure during the total thyroidectomy. We hypothesized that the use of CoolSeal would reduce the operating time and bleeding without complications increase. Study design represents a retrospective cohort study with a tertiary reference center setting. Methods. We analyzed total thyroidectomy data from January 2021 to June 2023. We recorded patients' characteristics, surgical information, and postoperative outcome. Results. We performed 221 total thyroidectomies in the study period. Analysis was restricted to 171 patients operated by only two surgeons. Hemostasis was secured by conventional ligation in 117 patients (68%), LigaSure in 34 patients (20%) and CoolSeal in 20 patients (12%). Median thyroid weight and bleeding were 67 g and 50 ml, respectively. Procedures using LigaSure or Cool-Seal were on larger glands (median 205 g) without increased bleeding (50 ml). Operating time was shortest with CoolSeal (96 min, p=0.003) compared with LigaSure (117 min) or conventional ligation (115 min). Bleeding was reduced with CoolSeal compared with LigaSure (45 vs. 100 ml, p=0.003). With CoolSeal, median hospitalization was one postoperative day, no patients required re-operation. There was no palsy of recurrent laryngeal nerves and no permanent hypoparathyroidism. Conclusion. In our first clinical experience, CoolSeal was safe and efficient for total thyroidectomy. With a small sample size, we saw a clinical benefit with reduced operating time without post-operative complications increase.

Practical, cost-effective removal of Hem-o-lok Weck clip: a novel technique.

The Hem-o-lok Weck clip is part of a polymer locking ligation system often employed for hemostasis in surgical practices. Its use is routine in a wide array of surgical subspecialties. Surgeons have limited options in removing these clips when they are aberrantly positioned. Herein, we describe a novel, cost-effective approach for removing a Hem-o-lok clip using standard robotic instruments. This simple approach will allow surgeons to remove a Hem-o-lok clip precisely and quickly if it is not adequately placed. During a routine robotic-assisted laparoscopic prostatectomy a Hem-o-lok Weck clip was noted to be in juxtaposition to the rectal wall, and it was deemed appropriate to remove it. Ultimately, the indwelling Prograsp forceps was moved from the right fourth arm position to the left arm position. This allowed the Prograsp forceps to compress the scissors in the right hand port, which was insufficient in cutting the hinge of the clip. This provided sufficient force to cut through the clip at its hinge with ease. The Hem-o-lok Weck clip is used in various surgical specialties. It is occasionally placed suboptimally and requires removal. Given the challenge of finding and using the clip removal device, surgeons should be aware of this simple and cost-effective way of removing a Hem-o-lok clip if desired.

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery.

BACKGROUND: In this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries. METHODS: This phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T4 - primary endpoint), seven (T7) and 10 (T10) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible. RESULTS: At T4, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T4 were undergoing soft tissue surgery. All patients achieved hemostasis by T7. At T10, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications. CONCLUSIONS: FS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel. LEVEL OF EVIDENCE: I.

Comparison of exsanguination and hemostasis devices for Limb surgery: a multicenter randomized controlled study.

BACKGROUND: Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). METHODS: This randomized controlled trial evaluates the exsanguination tourniquet ring's effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. RESULTS: The experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device. CONCLUSIONS: The exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries. TRIAL REGISTRATION: Comparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

Comparison of two haemostasis techniques on procedural duration, postoperative pain and gastrointestinal function in pet rabbits undergoing ovariohysterectomy.

Ovariohysterectomy is a common surgical procedure in pet rabbits and one of its potential complications is postoperative gastrointestinal stasis, possibly exacerbated by prolonged surgery time. The objective of this prospective clinical study was to compare two techniques for surgical haemostasis with respect to procedural duration, postoperative pain, and return of gastrointestinal function, in 22 female rabbits undergoing ovariohysterectomy. Rabbits were assigned to one of two groups: conventional vessel ligation (CVL) and haemostasis with a vessel sealing device (VSD). The outcome variables for comparison between the two groups, recorded at 60-, 120-, 180-, and 360-minutes post anaesthesia, were duration of anaesthesia and surgery, postoperative Rabbit Grimace Scale scores, and measured food intake and faecal output. The vessel sealing device caused no appreciable blood loss. The duration of both surgery and anaesthesia was shorter in group VSD (20 ± 4 and 31 ± 6 minutes, respectively) than in group CVL (43 ± 9 and 54 ± 9 minutes, respectively) (p < 0.001). There were no differences between groups in time elapsed from the end of anaesthesia to both first food intake and first defecation. In both groups, the score of the Rabbit Grimace Scale decreased over time with statistically significant differences between 60 minutes and all the subsequent time points (p < 0.001). Vessel sealing devices may be recommended over conventional haemostasis for rabbit ovariohysterectomy to decrease the duration of surgery and anaesthesia, with potential beneficial effects on sustainability and practice workflow.

The evolution of tumor enucleation partial nephrectomy: A comparison of perioperative outcomes for sutureless hemostatic bandage as an alternative to standard renorrhaphy.

BACKGROUND: The standard approach to hemostasis during partial nephrectomy (PN) is to perform suture renorrhaphy (SR). Application of a hemostatic bandage (HB) is an alternative to minimize blood loss and devitalized renal parenchyma. We aim to evaluate perioperative outcomes of PN with tumor enucleation (TE) comparing SR to HB. METHODS: We analyzed a retrospective cohort of 195 patients undergoing robot-assisted laparoscopic PN with TE performed at a tertiary referral center (2012-2022). Hemostasis was obtained with SR in 54 patients while 141 patients underwent application of HB consisting of Surgicel®, Gelfoam® soaked in thrombin, and Floseal®. RESULTS: SR patients had tumors of greater complexity by RENAL nephrometry score compared to HB patients (p < 0.001). Operative time (141 vs. 183 min, p < 0.001), warm ischemia time (11.6 vs. 24.2 min, p < 0.001), estimated blood loss (37 vs. 214 mL, p < 0.001), and length of stay (1.2 vs. 1.8 days, p < 0.001) favored HB. There was no significant difference in Clavien-Dindo grade ≥3 complications (p = 0.22). Renal function was comparable with mean estimated glomerular filtration rate decrease of 0.66 and 0.54 mL/min/1.73 m2 at 3 months postoperatively for HB and SR, respectively (p = 0.93). CONCLUSIONS: Application of an HB is a safe alternative to SR for hemostasis following PN with TE in appropriately selected patients.

Prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors.

BACKGROUND: It is uncertain whether prothrombin complex concentrate (PCC) improves hemostasis in patients on treatment with oral factor Xa-inhibitors (XaI) who require emergency surgery. OBJECTIVES: To evaluate whether, in patients with therapeutic levels of oral XaI, preoperative PCC prevents excessive bleeding during and after emergency surgery and is not associated with thrombotic complications. METHODS: We conducted a prospective cohort study wherein a fixed 2000 IU dose of 4-factor PCC was given to patients taking oral XaI with plasma XaI levels of at least 75 ng/mL before the emergency surgery with an expected blood loss of at least 50 mL. Patients were followed for 30 days. The primary efficacy outcome was the incidence of normal or mildly abnormal surgical hemostasis, as assessed by the surgeon; primary safety outcome was the incidence of thromboembolic events within 7 days. RESULTS: We included 20 patients, of which 50% were female, on apixaban (75%) or rivaroxaban (25%) with median XaI level of 128 ng/mL (range, 77-497 ng/mL). The median duration of surgery was 2 hours 42 minutes (range, 15 minutes to 8 hours 17 minutes). Normal or mildly abnormal hemostasis was observed in 16 patients (80%); 2 patients had moderately abnormal and 2 had severely abnormal hemostasis, 1 each of those was considered due to local or technical factors. There were 4 deaths (20%) secondary to underlying disease and 1 incidental pulmonary embolism in a patient with cancer. CONCLUSION: A fixed dose of PCC appears to control hemostasis in patients with therapeutic plasma levels of apixaban or rivaroxaban requiring emergency surgery.

Optimizing hemostasis in HoLEP surgery: retrospective review of selective bipolar plasmakinetic technology guided by bladder irrigation fluid color.

OBJECT: To evaluate the effectiveness of selective bipolar plasmakinetic technology based on bladder irrigation fluid color on hemostasis in HoLEP surgwery METHODS: A total of 209 patients who underwent HoLEP surgery from October 2021 to July 2023 were included and divided into Hemostasis Management Group and control group. the color of the irrigation fluid was categorized into 5 levels and the bipolar plasmakinetic technology was applied when the color came to level 4 or up. The following was analyzed: postoperative use of balloon compression, blood loss, irrigation time, length of hospital stay, and the number of a second operation. RESULTS: Only 4 patients in Hemostasis Management Group required postoperative urinary catheter balloon compression, while there are 15 in the control group(p=0.03). The average irrigation time for patients in the HM Group with bipolar plasmakinetic hemostasis was 21.88±13.76 hours, compared to that in patients with catheter balloon compression(p=0.007). CONCLUSION: Based on the bladder irrigation color chart, the selective application of bipolar plasmakinetic hemostasis led to a significant reduction in the number of patients requiring postoperative bladder catheter balloon compression. Secondly, the irrigation time of patients who underwent bipolar plasmakinetic hemostasis also decreased.

Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial.

BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery. METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. DISCUSSION: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .

Neuraxial Anesthesia Following Thrombocyte Transfusion in Women with Severe Thrombocytopenia Prior to a Cesarean Delivery: A Retrospective Study and Literature Review.

BACKGROUND: Cesarean delivery (CD) is one of the most common surgeries performed worldwide, with increasing yearly rates. Although neuraxial techniques remain the preferred anesthesia method for CD, maternal thrombocytopenia remains a prominent contraindication. Formation of spinal\epidural hematomas are extremely rare, however the minimal thrombocyte count required for safe neuraxial anesthesia is still under debate. Although transfusion of thrombocytes for the purpose of neuraxial anesthesia is still not recommended, patients with severe thrombocytopenia (less than 50 × 103/uL) are given thrombocyte transfusion for surgical hemostasis. OBJECTIVES: To evaluate the anesthetic approach to caesarean deliveries in parturients with severe thrombocytopenia who received thrombocyte transfusion aimed for improved surgical hemostasis. METHODS: We conducted a single center, retrospective cohort study. Results: A total of five cases were found, four of which were given spinal anesthesia immediately following thrombocyte transfusion. One patient was denied spinal anesthesia because her thrombocyte count following transfusion failed to reach safe levels. None of our cases had anesthesia-related complications recorded. CONCLUSIONS: We examined the anesthetic management parturients with severe thrombocytopenia who needed cesarean delivery and were transfused with thrombocytes for surgical hemostasis. In such cases, spinal anesthesia may be considered due to the serious risks associated with general anesthesia.

Simultaneous sealing and bisection of porcine renal blood vessels, ex vivo, using a continuous-wave, infrared diode laser at 1470 nm.

Electrosurgical and ultrasonic devices are used in surgical procedures for hemostatic sealing and bisection of vascular tissues. Previous benchtop studies alternatively demonstrated successful infrared laser sealing and cutting of blood vessels, in a sequential, two-step approach. This study describes a smaller, laparoscopic device compatible design, and simultaneous approach to sealing and bisection of vessels, with potential optical feedback. A 1470-nm infrared diode laser sealed and bisected 40 porcine renal arteries, ex vivo. A reciprocating, side-firing, optical fiber, housed in a transparent square quartz optical chamber (2.7 × 2.7 × 25 mm outer dimensions), delivered laser energy over an 11 mm scan length, with a range of incident powers (41-59 W) and treatment times (5-21 s). Vessel diameters ranged from 2.5 to 4.8 mm. Vessel burst pressure measurements were performed on each cut end (n = 80) with success indicated by pressures exceeding 360 mmHg. All vessel ends were successfully sealed and bisected (80/80). The highest incident power, 59 W, yielded short treatment times of 5-6 s. Peak temperatures on the external chamber surface reached 103 oC. Time to cool down to body temperature measured 37 s. Infrared lasers simultaneously seal and bisect blood vessels, with treatment times comparable to, and temperatures and cooling times lower than reported for conventional devices. Future work will focus on integrating the fiber and chamber into a standard 5-mm-outer-diameter laparoscopic device. Customization of fiber scan length to match vessel size may also reduce laser energy deposition, enabling lower peak temperatures, treatment times, and cooling times.

Comparative Analysis of Hemostasis and Staple-Line Integrity between Medtronic Tri-StapleTM with Preloaded Buttress Material and the AEONTM Stapler in Bariatric Surgery.

Background and Objectives: Haemostasis-related complications associated with Medtronic Tri-stapleTM with preloaded buttress material and the novel, naked AEONTM gastrointestinal staplers have not been extensively studied in bariatric surgery. The study aimed to assess and compare the 30-day haemostasis-related complications between Medtronic Tri-stapleTM and AEONTM GIA staplers. Methods: A retrospective analysis was performed on data from patients who underwent primary or revision sleeve gastrectomy (SG) or the sleeve component of single anastomosis duodeno-ileal bypass with SG (SADI-S) in a private hospital in Australia between November 2021 and December 2022. The surgeries were performed by a single surgeon, using either Medtronic Tri-stapleTM or AEONTM staplers. Results: The analysis included 250 patients, with the first 125 consecutive patients receiving staple line using the Medtronic Tri-stapleTM GIA stapler and the subsequent 125 patients receiving staple line using the AEONTM GIA stapler. Statistical analysis revealed no significant differences in the distribution of surgical procedures between the Medtronic and AEON groups. In the AEON group, there were statistically higher numbers of diabetics and former tobacco users, while other preoperative characteristics did not significantly differ between the two groups. The AEON group had a significantly longer mean operative time, while the length of hospital stay was significantly shorter. No intraoperative or 30-day complications, deaths, emergency room visits, readmissions, or reoperations were observed in either group. Conclusion: The novel, naked AEONTM stapler demonstrated non-inferiority to the established Medtronic Tri-StapleTM with preloaded buttress material in achieving hemostasis and maintaining staple-line integrity in bariatric surgery.

Blunt dissection method using HiQ+ soft coagulation system for laparoscopic cholecystectomy in acute cholecystitis.

INTRODUCTION: During laparoscopic cholecystectomy for acute cholecystitis, it is often difficult to keep the surgical view dry because of inflammation-related tissue fragility and susceptibility to bleeding. The resulting inadequate surgical view can lead to bile duct or vascular injury. Soft coagulation systems are used to achieve hemostasis during various surgeries; however, the usefulness of soft coagulation during laparoscopic cholecystectomy for acute cholecystitis is unclear. We here demonstrate the usefulness and feasibility of blunt dissection and soft coagulation during this procedure. MATERIALS AND SURGICAL TECHNIQUE: We used blunt dissection and soft coagulation when performing laparoscopic cholecystectomy on two patients with acute cholecystitis. As with conventional laparoscopic cholecystectomy, four ports were inserted. After cutting the serosa by electrocautery, blunt dissection using soft coagulation was performed, exposing the inner subserosa. Maintaining this layer using blunt dissection with soft coagulation achieved a sufficiently clear view for safety. After resecting the cystic artery and duct, the gallbladder bed was also dissected by blunt dissection with soft coagulation. Blood loss was <20 mL in both patients. DISCUSSION: Blunt dissection with soft coagulation may be a useful and feasible means of keeping the surgical view dry and minimizing blood loss during laparoscopic cholecystectomy for acute cholecystitis.

Utilization of harmonic scalpel for the bloodless surgical management of a vascular lesion of the tongue and review of the literature.

A constant search for methods to limit blood loss, especially the vascular lesions of the tongue, has led to the acceptance of ultrasonic harmonic scalpels.The harmonic scalpel's reliability exists in its ability for lasting hemostasis with minimal heat dispersion to the surrounding structures.Surgical removal of the vascular pathology in a restricted area of the oral cavity and oropharynx dictates a bloodless surgical field, further allowing increased visibility of the lesion and the surrounding anatomical structures, subsequently narrowing the surgical time frame.We report a rare case of haemangioma of the lateral border of the tongue managed with complete resection of the tumor achieved using the harmonic scalpel with reduced intraoperative blood loss, increased visibility, evidently reduced post-operative necrosis and highly preserved tissue for the histopathological examination.

The role of sealants for achieving anastomotic hemostasis in vascular surgery.

BACKGROUND: During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients. OBJECTIVES: To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023. SELECTION CRITERIA: We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients. DATA COLLECTION AND ANALYSIS: We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes. AUTHORS' CONCLUSIONS: Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.

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.