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Objective To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug's noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively). Conclusion: A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal. [ABSTRACT FROM AUTHOR]

Objectives: To describe our technique to perform tubeless percutaneous nephrolithotomy (tPCNL) using hemostatic matrix (i.e. Floseal®) for the closure of the percutaneous tract, developed through the experience gained in our endourology specialized center. To evaluate the procedure efficacy and safety. Methods: tPCNL performed in our center with Floseal® application from February 2017 to December 2019 were retrospectively reviewed. Clinical and surgical data were collected in order to evaluate the success of the procedure and possible complications. Camposampiero technique is reported in detail. Results: Sixty-nine patients (45 males, mean age 58 years old) were included. In all patients the procedure was completed successfully and in 88% of subjects no further treatments were necessary; a low complication rate (6.9%) was reported. Conclusion: In our experience, tPCNL with Floseal application is feasible, safe, and effective. [ABSTRACT FROM AUTHOR]

Study Design. Retrospective cohort study with interrupted time series analysis. Objective. To examine the clinical effectiveness of gelatinthrombin matrix sealant (GTMS) on blood loss reduction after adolescent idiopathic scoliosis (AIS) surgery. Summary of Background Data. The real-world effectiveness of GTMS on blood loss reduction in AIS surgery has not been determined. Patients and Methods. The medical records of patients receiving AIS surgery were retrospectively collected during a period before GTMS approval at our institution (January 22, 2010-January 21, 2015) as well as during a postintroduction period (January 22, 2015-January 22, 2020). The primary outcomes were intraoperative blood loss, drain output over 24 hours, and total blood loss (intraoperative blood loss + drain output over 24 h). Interrupted time series analysis using a segmented linear regression model was used to estimate the effect of GTMS on blood loss reduction. Results. A total of 179 AIS patients [mean age (range): 15.4 (11-30) yr; 159 females and 20 males; 63 preintroduction patients and 116 postintroduction patients] were included. After its introduction, GTMS was used in 40% of cases. Interrupted time series analysis revealed changes of -340 mL (95% CI: -649 to -31, P = 0.03) for intraoperative blood loss, -35 mL (95% CI: -124 to 55, P = 0.44) for drain output over 24 hours, and -375 mL (95% CI: -698 to -51, P = 0.02) for total blood loss. Conclusions. The availability of GTMS was significantly associated with reduced intraoperative and total blood loss in AIS surgery. GTMS use as needed is recommended to control intraoperative bleeding in the setting of AIS surgery. [ABSTRACT FROM AUTHOR]

To evaluate the role of FloSeal for preventing symptomatic lymphocele following pelvic and/or para-aortic lymphadenectomy in patients with gynecological cancers. Between October 2014 and April 2015, 40 patients with gynecological cancers planned for surgical management were randomly placed into FloSeal and non-FloSeal groups in a 1:1 ratio. Lymphocele incidence was evaluated using intravenous contrast-enhanced, abdominopelvic computed tomography 3--6 months after surgery. The quality of life questionnaire was completed by patients at 1, 3 and 6 months after surgery. The incidence of symptomatic lymphocele was compared using a chi-square test. All patients underwent bilateral pelvic lymph node dissection, and eight patients in each group (40% vs. 44.4%, p > 0.999) underwent para-aortic lymph node dissection. The mean number of total, right pelvic, left pelvic and para-aortic lymph nodes retrieved was similar between the groups. One patient (1/20, 5%) in the FloSeal group and three (3/18, 16.7%) in the non-FloSeal group developed lymphoceles (p = 0.328). The incidence of symptomatic lymphocele was 0% and 11% (2/18) in the FloSeal and non-FloSeal groups (p = 0.218), respectively. The mean time interval to drain removal (4.8 ± 2.0 days vs. 5.3 ± 2.2 days, p = 0.400) was shorter and the mean drain volume (1656 ± 1362 mL vs. 2022 ± 2301 mL, p = 0.550) was smaller in FloSeal group. The use of FloSeal after pelvic and/or para-aortic lymphadenectomy in patients with gynecological cancers may be effective for preventing symptomatic lymphocele. Clinical Trial registration: NCT01679483. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the prophylactic use of Floseal in reducing postoperative blood loss in patients undergoing Transforaminal Lumbar Interbody Fusion (TLIF). TLIF is a lumbar spine decompression and fusion procedure with potential for postoperative blood loss. Prophylactic application of Floseal, a gelatin and thrombin-based haemostatic matrix to the surgical wound before closure was shown to be effective in reducing postoperative drain output in anterior cervical discectomy and fusion. This study postulated that prophylactic use of Floseal before wound closure would reduce postoperative blood loss in patients who underwent TLIF. Methods: Randomised controlled trial comparing prophylactic use of Floseal and control in patients undergoing single level or two-level TLIF. Primary outcomes included postoperative drain output within 24 h and postoperative transfusion rate. Secondary outcomes included days of drain placement, length of stay and haemoglobin level. Results: A total of 50 patients was recruited. Twenty six patients were allocated to the Floseal group and 24 were allocated to the control group. There were no baseline characteristic differences between the groups. There were no statistically significant differences in primary outcomes which included postoperative drain output within 24 h and postoperative transfusion rate between patients who received prophylactic Floseal and control. There were no statistically significant differences in secondary outcomes which included haemoglobin level, days of drain placement and length of stay between the two groups. Conclusion: Prophylactic use of Floseal was not shown to reduce postoperative bleeding in single level or two-level TLIF. [ABSTRACT FROM AUTHOR]

Uncontrolled bleeding is linked to higher treatment costs, risk of post-surgical infection and increased disease and death. Hemostatic agents are used to treat excessive bleeding. A good hemostatic agent controls bleeding effectively, reduces the need for blood transfusion, removes the need for systemic drugs to control bleeding, results in shorter surgery time, and reduces the cost and length of hospital stay of the patient. Gelatin-based hemostatic agents have been widely used in medical and dental procedures, owing to their biodegradability and biocompatibility, as well as availability and low cost of raw materials. In this narrative literature review, we discuss the background and different types of gelatin-based hemostatic agents in medical and dental procedures, the comparison of gelatin-based and non-gelatin-based hemostatic agents, and the usage and development of enhanced or novel gelatin-based hemostatic agents. Gelatin-based hemostatic agents are effective and important part of bleeding control, as evidenced by its wide application in medicine and dentistry. The development of novel combination gelatin-based hemostatic agents has much potential for effective control of excessive bleeding.

Walter Danker III,1 Jyoti Aggarwal,2 Sneha S Kelkar,2 Xiaocong L Marston,2 Xin Gao,2 Stephen S Johnston3 1Ethicon Inc., Somerville, NJ, USA; 2OPEN Health, Bethesda, MD, USA; 3Johnson & Johnson Co., New Brunswick, NJ, USACorrespondence: Jyoti Aggarwal, OPEN Health, 4350 East West Hwy #1100, Bethesda, MD, 20814, USA, Tel +1-240-821-1265, Email jyotiaggarwal@OpenHealthgroup.comBackground: Topical hemostatic agents are an option for controlling bleeding during cardiovascular surgery. Previous studies comparing topical hemostatic agents in cardiovascular surgery predate the 2012 reformulation of Surgiflo®, which had been re-engineered to increase paste viscosity and thus be more adherent to the bleeding surface.Objective: To compare clinical and economic outcomes in patients receiving the current formulation of Surgiflo vs Floseal during cardiovascular surgeries.Methodology: A retrospective analysis was conducted using the Premier Healthcare Database. Eligible patients had an inpatient cardiovascular surgery between 1/1/2013 and 6/1/2018, were ≥ 18 years old and received the current formulation of Surgiflo or Floseal during surgery. Propensity score matching was performed, with exact matching on the surgery year and surgery type (aortic, coronary artery bypass grafting, valve, or other). Descriptive analysis and generalized estimating equations models compared outcomes between the Surgiflo and Floseal groups.Results: The matched sample included 5768 patients in each group (mean age: 66.5 years; 66.3% male). In the matched sample, rates of any documented bleeding event were similar in Surgiflo and Floseal groups (6.9% vs 7.2%; P = 0.576). Differences in transfusion rates between patients receiving Surgiflo vs Floseal varied by operational definition and timing of measurement but did not differ by > 2 percentage points. Compared to Floseal, patients who received Surgiflo experienced longer surgery duration (306.0 vs 299.4 minutes), lower hospitalization cost ($44,146 vs $46,812), and lower odds of readmission at 30, 60, and 90 days post-discharge (all P < 0.05). Inpatient mortality and LOS were comparable between Surgiflo and Floseal (all P > 0.05).Conclusion: In this large study of real-world clinical and economic outcomes after cardiovascular surgery involving the current formulation of Surgiflo vs Floseal, Surgiflo was associated with mostly similar clinical outcomes as compared with Floseal. Differences in selected economic/resource use outcomes were also observed, for which root-cause analysis in future research would be informative.Keywords: Surgiflo®, Floseal, cardiovascular surgery, economic outcomes, bleeding, transfusion

Uncontrolled bleeding is linked to higher treatment costs, risk of post-surgical infection and increased disease and death. Hemostatic agents are used to treat excessive bleeding. A good hemostatic agent controls bleeding effectively, reduces the need for blood transfusion, removes the need for systemic drugs to control bleeding, results in shorter surgery time, and reduces the cost and length of hospital stay of the patient. Gelatin-based hemostatic agents have been widely used in medical and dental procedures, owing to their biodegradability and biocompatibility, as well as availability and low cost of raw materials. In this narrative literature review, we discuss the background and different types of gelatin-based hemostatic agents in medical and dental procedures, the comparison of gelatin-based and non-gelatin-based hemostatic agents, and the usage and development of enhanced or novel gelatin-based hemostatic agents. Gelatin-based hemostatic agents are effective and important part of bleeding control, as evidenced by its wide application in medicine and dentistry. The development of novel combination gelatin-based hemostatic agents has much potential for effective control of excessive bleeding. [ABSTRACT FROM AUTHOR]

Background The use of thrombin-based hemostatic agents (TBHAs) has become common practice in most neurosurgical procedures, both cranial and spinal. Methods We present the case of a 40-year-old woman who was referred to our institution with intense headache and Fisher grade 3 subarachnoid hemorrhage (SAH) mainly at the level of the right sylvian fissure, caused by a 5.71-mm right middle cerebral artery (MCA) bifurcation aneurysm, with hourglass morphology and a bleb on the bottom. Cerebral angiography demonstrated aneurysm enlargement, compared with the prior angiographic computerized tomography scan. Results A right pterional craniotomy was performed. After initial arachnoid dissection to get proximal vascular control, but before we obtained it, we witnessed profuse bleeding from the aneurysm. Floseal, a gelatin-thrombin matrix sealant, was sprayed over the breach of the aneurysm, and cottonoids were gently pressed with a self-retaining spatula, stopping the hemorrhage. After that, we obtained proximal control with an extradural clinoidectomy and temporary clipping of the right internal carotid artery (ICA) and MCA. Finally, aneurysm dissection and final clipping were performed with the application of two clips. The postoperative course was uneventful, and the patient was discharged on postoperative day 10. Conclusion Intraoperative aneurysm rupture (IAR) is a dangerous event that carries great risks—even death. Proper use of TBHAs is a useful and safe way to stop the bleeding, take a deep breath, and achieve proximal vascular control. To the best of our knowledge, this is the first report of the use of TBHA during aneurysm clipping. [ABSTRACT FROM AUTHOR]

Purpose: Management of bleeding during surgery can be aided by the application of topical hemostatic agents. This study compared the hemostatic efficacy of a new powder agent containing collagen, chondroitin sulfate, and thrombin (PCCT) with a flowable gelatin-thrombin matrix with smooth particles (SmGM) in a porcine liver bleeding model. Materials and Methods: Lesions 4–6 mm deep and ∼10 mm in diameter were created in porcine livers and treated with either SmGM or PCCT. Bleeding rate and grade were quantified before and 3, 7, and 11 minutes after treatment. Results: Thirty-two lesions each were treated with SmGM or PCCT; the median (Q1, Q3) initial bleeding rate was comparable between the two groups (8.43 [6.18, 10.68] g/min and 7.15 [5.16, 9.63] g/min, respectively). The residual bleeding rate was significantly lower at all time-points post treatment for SmGM compared with PCCT (3 minutes: 0.14 [0.07, 0.21] versus 0.46 [0.20, 1.20] g/min, p

Advanced breast cancer can present with bleeding tumors that are difficult to control using traditional techniques. The use of topical agents has been reported in the local management of bleeding malignant tumors. We report a challenging case of persistent bleeding in a 40-year-old female patient with metastatic breast cancer, presenting with significant uncontrollable bleeding from the fungating breast tumor where conventional measures failed to halt blood loss. We report the successful hemostasis using Floseal (topical hemostatic agent) in combination with local dressing. We recommend that topical application of Floseal should be considered in the management of uncontrolled bleeding due to fungating malignant wounds. Liaising with tissue viability specialists is essential for optimum management and other symptom control. Larger scale comparative studies are needed to further explore these findings., Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Abid et al.)

Objective: Major vascular injury is one of the most important causes of death after trauma. The effective and speedy control of the hemorrhage is crucial in reducing deaths. Many products are used for this purpose. Today, however, an ideal product has not yet been produced and there is a strong demand for such effective hemostatic products. The aim of this study is to compare the efficacy of Algan hemostatic agent with Floseal in the liver laceration model in rats. Materials and Methods: A total of 28 rats were used in the study. Rats were divided into 4 groups, each consisting of 7 rats. Experimental liver laceration was established. In the control group, saline-impregnated gauze was applied. Algan hemostatic agent-impregnated sponge, Algan hemostatic agent powder, and Floseal gel were applied to the experimental groups. Results: There was no difference in bleeding control among the Algan hemostatic agent powder, Algan hemostatic agent-impregnated sponge, and Floseal. When compared to the control group, Algan hemostatic agent powder, Algan hemostatic agent-impregnated sponge, and Floseal were found to be very effective in bleeding control, respectively (P = .001, .012, and .002), in the experimental groups. Conclusion: This study showed that the properties of both Algan hemostatic agent powder and Algan hemostatic agent-impregnated sponge for controlling bleeding are similar to Floseal. Considering other characteristics such as Algan hemostatic agent's naturalness, easy applicability, and low cost, Algan hemostatic agent has been a promising effective hemostatic agent. [ABSTRACT FROM AUTHOR]

Background Context: Early postoperative MR images are frequently necessary after spine surgery. The appearance of commonly used adjunct hemostatic agents and dural sealants in MR images has not been systematically evaluated.Purpose: The purpose of this experimental study was to systematically analyze and describe the characteristics of the most commonly applied hemostatic agents and dural sealants in spine surgery on early postoperative MR images.Study Design: Cadaver Study METHODS: Four commonly applied dural sealants (Duraseal, Bioglue, Tachosil, Tisseel) and five commonly used hemostatic agents (Surgiflo, Bonewax, , Spongostan, Gelfoam, Avitene) were investigated. The experimental setting involved a human cadaver where a standard left-sided laminotomy was performed on nine levels of the thoracolumbar spine, and the materials were separately applied and mixed with fresh blood or water for hemostatic and dural sealants, respectively. The cadaver model was scanned at a 3 Tesla MRI and the imaging findings for all materials were compared to the surrounding tissue and systematically reported.Results: All investigated dural sealants and hemostatic agents were distinguishable from the surrounding tissue on MR images with different appearances on the MR sequences. A detailed atlas for the identification of the materials in postoperative spine MRI was established.Conclusion: Commonly used hemostatic agents and dural sealants can be successfully identified on early postoperative spine MRI.Clinical Significance: Knowledge about MRI appearances of commonly used adjunct surgical materials helps in interpretation of postoperative imaging and supports clinical decision making. [ABSTRACT FROM AUTHOR]

Background: An under‐recognized complication of gelatin‐based haemostatic agents is their potential to cause anaphylactic reactions. This review aims to collate and analyse case in the literature of intraoperative anaphylaxis secondary to locally applied haemostatic agents. Methods: An electronic search was performed on databases Medline, Embase, Pubmed and ProQuest. A total of 7671 articles were reviewed from title and abstract. After exclusion criteria and duplicates removed, 19 articles with 21 cases were included for analysis. Data extracted from each of the articles included patient demographics, haemostatic agent used, surgery type, known allergies and any objective evidence of hypersensitivity post anaphylactic episode, that is tryptase levels, IgE levels, skin prick testing. Results: Fifty‐seven percent of cases involved patients <18 years of age; 57% of cases involved spinal surgery; 100% of cases displayed objective evidence of hypersensitivity (tryptase levels, bovine or porcine IgE levels, or skin prick testing). Thirty‐three percent of patients had exposure preoperatively to a known agent causing anaphylaxis or allergy which would preclude the use of a gelatin‐based haemostat. These products included vaccines, spam meats, red meat, Jell‐O and CollaPlug. Gelatin‐based haemostat agents included Floseal, Gelfoam, Surgiflo, fibrin glue, Avitene, haemofibrine sponge, topical bovine thrombin and thrombin‐soaked gelatin. Conclusion: Increased awareness of allergy to gelatin‐based haemostats for surgical and anaesthetic is imperative, with 33% of cases having a known contraindication to gelatin‐based haemostat. This review highlights important aspects in the pre‐operative patient history and post‐event patient investigation that could assist anaesthetists and surgeons in the prevention of future events. [ABSTRACT FROM AUTHOR]

Purpose: Topical hemostatic agents are an important means of controlling or preventing bleeding. This study was performed to compare gelatin–thrombin matrix with smooth particles (SmGM) versus gelatin–thrombin matrix with stellate particles (StGM) in a porcine kidney bleeding model. Materials and methods: In male pigs, reproducible lesions (diameter and depth ∼10 mm) were created in the renal cortex. Each lesion was treated topically using either SmGM or StGM. Blood loss was quantified before and 2, 5 and 10 minutes after treatment. Dry mass, ultrastructural and histologic analyses were also performed. Results: Thirty-two lesions were treated with SmGM and 32 with StGM; median initial bleeding rates were 27.6 and 29.1 mL/min, respectively. Two minutes post-application, SmGM was associated with significantly less bleeding than StGM (0.574 vs 0.920 mL/min; p < .0001). This difference stemmed principally from lesions with initial blood loss >29 mL/min, where bleeding rates at 2 minutes were ∼3-fold higher with StGM (1.636 vs 0.567 mL/min; p ≥ 0.040). Dry mass per unit volume of hemostatic agent was significantly higher with SmGM versus StGM. SmGM formed discrete, smooth particles, while StGM particles were stellate and tended to coalesce. Histologic analysis showed more solid mass, larger particles and less intervening space with SmGM versus StGM. Conclusions: In a severe, high-volume bleeding model, residual bleeding at 2 minutes was significantly lower with SmGM versus StGM, and SmGM showed greater consistency across bleeding intensities. These findings may be attributable to dry mass per unit volume and/or ultrastructural differences between the two agents.

• Haemostatic sealant is a feasible and effective option for haemostasis. • The antral follicle count is higher in the haemostatic sealant group at 1 year. • The use of haemostatic sealant does not increase endometrioma recurrence. Is there a difference in the ovarian reserve 1 year post-operatively in those who used a haemostatic sealant or bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy for ovarian endometriomas? This was an extended follow-up observational study of a previous randomized controlled trial where women aged 18 to 40 years with 3–8 cm unilateral or bilateral endometriomas were randomized to receive haemostasis by a haemostatic sealant or bipolar diathermy following ovarian cystectomy. The primary outcome was the ovarian reserve as assessed by antral follicle count (AFC) 1 year post-operatively. Secondary outcomes included the recurrence rate of ovarian endometrioma, the change in anti-Müllerian hormone (AMH) and FSH concentrations, and reproductive outcomes. The significant increase in AFC at 3 months after initial surgery (P = 0.025) in the haemostatic sealant group compared with the diathermy group was sustained at 1 year (P = 0.024) but there was no difference in AMH or FSH concentrations between the groups throughout the follow-up period. The recurrence rate in the FloSeal group was 7.7% (n = 3/39) compared with 22.2% (n = 8/36) in the diathermy group (P = 0.060). The recurrence rate in women who had bilateral lesions was significantly higher than those with unilateral lesions (risk ratio 5.33, interquartile range 1.55–18.38). No difference in reproductive outcomes was found between the two groups. Applying haemostatic sealant after laparoscopic cystectomy of ovarian endometriomas produces a significantly greater improvement in AFC, which was apparent at 3-month follow-up, and was sustained at 1-year follow-up without compromising the recurrence rate. [ABSTRACT FROM AUTHOR]

Purpose: Management of bleeding during surgery can be aided by the application of topical hemostatic agents. This study compared the hemostatic efficacy of a new powder agent containing collagen, chondroitin sulfate, and thrombin (PCCT) with a flowable gelatin-thrombin matrix with smooth particles (SmGM) in a porcine liver bleeding model. Materials and Methods: Lesions 4–6 mm deep and ∼10 mm in diameter were created in porcine livers and treated with either SmGM or PCCT. Bleeding rate and grade were quantified before and 3, 7, and 11 minutes after treatment. Results: Thirty-two lesions each were treated with SmGM or PCCT; the median (Q1, Q3) initial bleeding rate was comparable between the two groups (8.43 [6.18, 10.68] g/min and 7.15 [5.16, 9.63] g/min, respectively). The residual bleeding rate was significantly lower at all time-points post treatment for SmGM compared with PCCT (3 minutes: 0.14 [0.07, 0.21] versus 0.46 [0.20, 1.20] g/min, p < 0.0001; 7 minutes: 0.07 [0.04, 0.11] versus 0.12 [0.08, 0.39] g/min, p = 0.001; 11 minutes: 0.05 [0.03, 0.08] versus 0.07 [0.05, 0.12] g/min, p = 0.043). Bleeding grade at 3 minutes was also significantly lower for SmGM compared with PCCT (median [Q1, Q3] 0.0 [0.0, 0.0] versus 1.0 [1.0, 2.0], p < 0.0001). PCCT required reapplication in approximately one-third of applications due to insufficient hemostasis 4 minutes after initial application and showed a tendency to stick to the wet gauze during approximation. Conclusions: In this bleeding model, treatment with SmGM resulted in reduced blood loss, no need for reapplication and was easier to apply compared with PCCT. [ABSTRACT FROM AUTHOR]

Background: One of the most common causes of trauma related deaths is hemorrhage due to splenic injury. The aim of the study was to compare the effects of hemostatic activities of Ankaferd blood stopper (ABS®), Oxidized Cellulose (Surgicel®) and FloSeal® in rats with experimental splenic injuries. Materials and Methods: In this study we used twenty-four female Wistar Albino rats. Grade 2 spleen laceration was performed on all rats. Rats were randomly divided into four groups each consist of 6 rats, as control, ABS, Surgicel and FloSeal. After performing grade 2 spleen laceration, sponge compression was applied to the control group and hemostatic agents were applied to the other groups. The amount and duration of bleeding and preoperative-postoperative hematocrit (Hct) levels were statistically compared between the groups. Results: The amount and duration of bleeding was at least in the group using FloSeal, followed by ABS, Surgicel and control group, respectively. The amount of bleeding was; 0.27±0.04gr, 0.38±0.08gr, 0.63±0.09gr and 1.0±0.2gr respectively. The duration of bleeding was; 65.66±10.63s, 70.16±8.13s, 214.00±17.98s and 381.83±59.09s respectively. The amount and duration of bleeding was less in all groups using hemostatic agent compared to the control group (p<0.001). In the groups using FloSeal and ABS, the amount and duration of bleeding were significantly lower than Surgicel group (the amount of bleeding was p<0.001 and p=0.011, bleeding time p<0.001 and p<0.001, respectively). Although the amount and duration of bleeding was found at least in the FloSeal group, but this difference was not statistically significant when compared with ABS group (bleeding amount p=0.476, duration p=0.842). Conclusion: In our study, hemostatic agents that can be used in hemorrhage due to splenic laceration were found much more effective in stopping bleeding than the control group. In particularly, it was observed that FloSeal and ABS provide hemostasis and reduce the amount of bleeding more effectively than oxidized cellulose. [ABSTRACT FROM AUTHOR]

Abstract Background Flowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS). Methods A cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately. Results Compared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%. Conclusions Despite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period.

We evaluated the hemostatic efficacy and immunogenicity of CollaStat compared with FloSeal in a rabbit jejunal artery injury model. A total of 27 experimental rabbits were used in the study. For each hemostatic agent, an injury was created in one of the right angles of the jejunal arteries originating from the vascular arcs. Time to hemostasis was determined after applying manual compression to the wound for 30 s, which was repeated a maximum of three times in cases of persistent bleeding. On postoperative day 7, the concentration of serum antithrombin antibody was measured among agent-treated and nontreated control groups. The mean time to hemostasis for CollaStat was significantly shorter than for FloSeal (64.0 ± 5.0 versus 84.0 ± 7.8 s; P = 0.040). There were no significant differences in rabbit serum mean anti-thrombin Ab concentration between CollaStat-treated, FloSeal -treated, and the control groups (8.43 ± 0.44 versus 8.18 ± 7.8 versus 9.58 ± 1.11 ng/mL; P = 0.065). According to our study, CollaStat was more efficient in achieving hemostasis in a rabbit jejunal artery injury and exhibited nonsignificant immunogenicity compared with FloSeal. These findings suggest that CollaStat has acceptable hemostatic potential for controlling significant arterial bleeding. [ABSTRACT FROM AUTHOR]

Purpose: Topical hemostatic agents are an important means of controlling or preventing bleeding. This study was performed to compare gelatin–thrombin matrix with smooth particles (SmGM) versus gelatin–thrombin matrix with stellate particles (StGM) in a porcine kidney bleeding model. Materials and methods: In male pigs, reproducible lesions (diameter and depth ∼10 mm) were created in the renal cortex. Each lesion was treated topically using either SmGM or StGM. Blood loss was quantified before and 2, 5 and 10 minutes after treatment. Dry mass, ultrastructural and histologic analyses were also performed. Results: Thirty-two lesions were treated with SmGM and 32 with StGM; median initial bleeding rates were 27.6 and 29.1 mL/min, respectively. Two minutes post-application, SmGM was associated with significantly less bleeding than StGM (0.574 vs 0.920 mL/min; p <.0001). This difference stemmed principally from lesions with initial blood loss >29 mL/min, where bleeding rates at 2 minutes were ∼3-fold higher with StGM (1.636 vs 0.567 mL/min; p ≥ 0.040). Dry mass per unit volume of hemostatic agent was significantly higher with SmGM versus StGM. SmGM formed discrete, smooth particles, while StGM particles were stellate and tended to coalesce. Histologic analysis showed more solid mass, larger particles and less intervening space with SmGM versus StGM. Conclusions: In a severe, high-volume bleeding model, residual bleeding at 2 minutes was significantly lower with SmGM versus StGM, and SmGM showed greater consistency across bleeding intensities. These findings may be attributable to dry mass per unit volume and/or ultrastructural differences between the two agents. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of haemostatic sealant compared with bipolar coagulation on ovarian reserve after laparoscopic cystectomy for ovarian endometriomas.Design: Patient-blinded, randomised controlled trial.Setting: University-affiliated tertiary hospital.Population: Women aged 18-40 years with 3-8 cm unilateral or bilateral endometriomas.Methods: Ninety-four patients were randomised to receive haemostasis by the application of haemostatic sealant (n = 47) or standard care (n = 47).Main Outcome Measures: Primary outcome was the effect on the antral follicular count 3 months after the operation as it captures the effect on the ovary subjected to treatment. Secondary outcomes included the change in anti-Mullerian hormone, follicular-stimulating hormone and peri-operative outcomes including haemostasis, complications, pain, and satisfaction scores.Results: A total of 94 patients aged 32.36 ± 4.92 years underwent laparoscopic cystectomy for ovarian endometriomas. The average diameter of the endometrioma was 4.21 ± 1.38 cm. The increase in antral follicle count of the affected ovaries at 3 months in the intervention group (+2.36 ± 0.37) was significantly (P = 0.013) higher than that in the control group (+1.08 ± 0.36). Repeated measures analysis of variance revealed significant effect with time (P < 0.001) and of interaction of group × time (P = 0.029) for affected ovary antral follicle count. No significant difference was noted between the two groups with regard to follicular-stimulating hormone, anti-Mullerian hormone, and other secondary outcomes.Conclusions: Applying haemostatic sealant after laparoscopic cystectomy of ovarian endometriomas produced a greater increase in antral follicle count 3 months after surgery compared with the control group.Tweetable Abstract: RCT: Haemostatic sealant in laparoscopic cystectomy of endometriomas increase in the antral follicle count after surgery. [ABSTRACT FROM AUTHOR]

Local hemostatic agents have been used in the neurosurgical field for many years; it is safe and efficient with no fatal complication reported in the literature. We routinely used a gelatin-thrombin hemostatic agent (FloSeal Hemostatic Matrix) for hemostasis in minimally invasive endoscopic-assisted surgery for more than 500 patients with intracerebral hemorrhage. However, 2 cases with sterile cyst formation were encountered. We reported 2 cases with sterile cyst formation after the use of a gelatin-thrombin hemostatic agent. Both of them had intracerebral hemorrhage. One received endoscopic hematoma evacuation, and the other had traditional craniotomy. They all received drainage of the cyst due to progressive enlargement and the mass effect they exert. These sterile cysts were very close to the ventricle wall on images. We hypothesized that cyst wall may be formed not only by hemostatic agent-related fibrosis and inflammation according to the previous literature review but also by the presence of the check valve mechanism between the cyst and the ventricle, which caused further dilation of the cyst. [ABSTRACT FROM AUTHOR]

Background Few studies have been published about percutaneous techniques for management of surgical bed hemorrhage during a stereotactic biopsy, a serious complication that may affect patient outcome. We describe the injection of a thrombin-gelatin matrix through the biopsy cannula as an effective method to arrest surgical bed bleeding that does not respond to conventional methods of hemostasis. Methods We prospectively documented image-guided stereotactic brain biopsy procedures in 30 awake patients between July 2014 and July 2017 at our center. Among patients presenting with intractable surgical bed bleeding, a thrombin-gelatin matrix injection through the biopsy cannula was performed. Details of the injection technique, surgical outcome, and complications were recorded. Results Among 30 documented stereotactic brain biopsies, 3 (10%) had intractable surgical bed bleeding during the procedure. In all 3 cases, thrombin-gelatin matrix was injected, and an immediate arrest of hemorrhage was achieved. None of the patients required a craniotomy or further invasive measure to achieve hemostasis. No postoperative complications were recorded. Conclusions Our preliminary results suggest that thrombin-gelatin matrix injection is a simple, safe, and effective stereotactic practice to manage persistent surgical bed bleeding that cannot be arrested by standard, conventional hemostatic methods. [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: To evaluate the cost-effectiveness of Floseal, a topically applied hemostatic agent, and nasal packing for the management of epistaxis in Canada.Study Design: Outcomes research, a cost-utility analysis.Methods: We developed a Markov model to compare the costs and health outcomes of Floseal with nasal packing over a lifetime horizon from the perspective of a publicly funded healthcare system. A cycle length of 1 year was used. Efficacy of Floseal and packing was sought from the published literature. Unit costs were gathered from a hospital case costing system, whereas physician fees were extracted from the Ontario Schedule of Benefits for Physician Services. Results were expressed as an incremental cost per quality-adjusted life year (QALY) gained. A series of one-way sensitivity and probabilistic sensitivity analyses were performed.Results: From the perspective of a publicly funded health are system, the Floseal treatment strategy was associated with higher costs ($2,067) and greater QALYs (0.27) than nasal packing. Our findings were highly sensitive to discount rates, the cost of Floseal, and the cost of nasal packing. The probabilistic sensitivity analysis suggested that the probability that Floseal treatment is cost-effective reached 99% if the willingness-to-pay threshold was greater than $120,000 per QALY gained.Conclusions: Prior studies have demonstrated Floseal to be an effective treatment for anterior epistaxis. In the Canadian healthcare system, Floseal treatment appears to be a cost-effective treatment option compared to nasal packing for anterior epistaxis.Level Of Evidence: 2c Laryngoscope, 1778-1782, 2018. [ABSTRACT FROM AUTHOR]

Association between the use of hemostatic agents made from collagen/gelatin mixed with thrombin and thromboembolic events in patients undergoing tumor resection has been suggested. This study evaluates the relationship between flowable hemostatic matrix and deep vein thrombosis in a large cohort of patients treated for brain tumor removal. The authors conducted a retrospective, multicenter, clinical review of all craniotomies for tumor removal performed between 2013 and 2014. Patients were classified in three groups: group I (flowable gelatin hemostatic matrix with thrombin), group II (gelatin hemostatic without thrombin), and group III (classical hemostatic). A total of 932 patients were selected: tumor pathology included 441 gliomas, 296 meningiomas, and 195 metastases. Thromboembolic events were identified in 4.7% of patients in which gelatin matrix with thrombin was applied, in 8.4% of patients with gelatin matrix without thrombin, and in 3.6% of cases with classical methods of hemostasis. Patients with venous thromboembolism had an increased proportion of high-grade gliomas (7.2%). Patients receiving a greater dose than 10 ml gelatin hemostatic had a higher rate of thromboembolic events. Intracranial hematoma requiring reintervention occurred in 19 cases: 4.5% of cases of group III, while reoperation was performed in 1.3 and 1.6% of patients in which gelatin matrix with or without thrombin was applied. Gelatin matrix hemostat is an efficacious tool for neurosurgeons in cases of difficult intraoperative bleeding during cranial tumor surgery. This study may help to identify those patients at high risk for developing thromboembolism and to treat them accordingly. [ABSTRACT FROM AUTHOR]

Purpose: To compare the effectiveness of TachoSil and Floseal during laparoscopic nephron-sparing surgery (LNSS), and to evaluate postoperative complications, especially hemorrhage and urinary leakage. Materials and Methods: The medical records of all patients that underwent LNSS for a small renal mass (SRM) performed by the same experienced surgeon were retrospectively analyzed. The patients were divided into the following 3 groups, based on hemostatic agent: group 1: no adjuvant hemostatic agent (no AHA); group 2: TachoSil; group 3: Floseal. Results: The study included 79 patients; no AHA group: n = 18; TachoSil group: n = 25; Floseal group: n = 36. The 3 groups were similar in terms of diameter [29.6 ± 11.5 mm, 26.4 ± 13.4 mm and 30.4 ± 9.6 mm, respectively (P = .218)] and PADUA scores [6.9 ± 0.9, 6.7 ± 1 and 6.9 ± 0.9, respectively (P =.540)]. Mean duration of surgery was significantly shorter in the Floseal group (120.9 ± 23.1 minutes) than in the no AHA group (156.6 ± 34.4 minutes). Mean ischemia time was longest in the no AHA group (24.3 ± 4 minutes) and shortest in the Floseal group (21.3 ± 4.3 minutes). Intra-abdominal (IA) catheter drainage on postoperative day 1 was significantly higher in the no AHA group than in the TachoSil and Floseal groups [156.9 ±78.3 mL vs. 72.6 ± 64.5 and 60.8 ± 30.2 mL, respectively (P < .05)]. Mean duration of hospitalization was 3.2 ± 0.5 days in the no AHA group that was significantly longer than in the Floseal group (2.8 ± 0.7 days) (P = .043). There were not any differences in intraoperative complications, the transfusion rate, surgical margin positivity, or postoperative complications between the 3 groups (P = .596, P = .403, P = 1.0, P = .876, respectively). However, pseudoaneurism as a late term complication occurred in 27.7% patients in the no AHA group. Conclusion: TachoSil and Floseal are safe and effective adjuvant treatments for patients undergoing LNSS. They might be useful especially in preventing pseudo aneurisms, shortening intraoperative ischemia time and hospital stay and decreasing postoperative drainage. Shortened operation and warm ischemia time may also be attributed to long learning curve of LNSS. [ABSTRACT FROM AUTHOR]

Background: To assess the changes in blood loss during hepatic resection with improved haemostatic devices such as a bipolar sealing device and a topical haemostatic agent. Methods: This retrospective clinical study of prospectively collected data will assess hepatic resections performed by a single surgeon between 2005 and 2013, with the introduction of the two haemostatic techniques in 2009. Results: A total of 371 hepatic resections (214 from 2005 to 2008 and 157 from 2009 to 2013) were included in this study. Compared with the conventional hepatic resection (2005–2008), the use of haemostatic techniques (2009–2013) significantly reduced the need for inflow occlusion (OR: 0.37, 95% CI: 0.24–0.57, P < 0.001), overall occlusion time (20.8 min versus 25.9 min, P = 0.04) and transfusion requirement (4.6% versus 12%, OR: 0.35, 95% CI: 0.14–0.90, P = 0.02). Mean overall blood loss was reduced post‐2009; however, the decrease was not statistically different (401.3 mL versus 470.8 mL, P = 0.27). Subgroup analysis revealed that blood loss was more than halved post‐2009 compared with pre‐2009 for patients who received pre‐operative chemotherapy (324.6 mL versus 738.5 mL, P = 0.005). Conclusion: The use of a bipolar sealing device and a topical haemostatic agent reduces the need for inflow occlusion, overall occlusion time and transfusions in all patients compared with conventional hepatic resections. [ABSTRACT FROM AUTHOR]

Background: Flowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS).Methods: A cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately.Results: Compared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%.Conclusions: Despite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the long-term effects of Floseal on erectile function recovery (EFR) after nerve-sparing robot-assisted radical prostatectomy (RALP). Methods: We prospectively collected results of the self-administered International Index Erectile Function Questionnaire 1-5 and 15 (IIEF 1-5 and 15) of 532 consecutive patients who underwent RALP for prostate cancer in our institution between October 2007 and December 2015. Patients were divided into two groups according to Floseal application after prostatectomy. They were enrolled according to the following criteria: (a) bilateral nerve-sparing procedure; (b) preoperative IIEF ≥ 17; adherence to our erectile rehabilitation protocol; (c) 1-year follow-up. Outcomes were measured as mean IIEF score, EFR (IIEF < 17 or ≥17), grade of ED: severe (IIEF < 17), moderate (17-21), mild (22-25) and no ED (>25). Results: A total of 120 patients were enrolled. Group A included 40 consecutive patients who received traditional hemostasis, and Group B included 80 consecutive patients in which Floseal was additionally used. No differences were observed in terms of preoperative mean IIEF score ( p = 0.65). Group B patients showed a trend toward a higher mean IIEF score 3 months after surgery ( p = 0.06) but no differences in terms of EFR ( p = 1.000). Long-term results (6, 9, 12 months after surgery) showed a significantly and progressively higher mean IIEF score ( p = 0.04, 0.003, 0.003) and EFR ( p = 0.043, 0.027, 0.004) in Group A patients. Comparison between the groups in terms of severe, moderate, mild and no ED becomes significant at 9 and 12 months ( p = 0.002, 0.006). Conclusion: The results of our study suggest that local use of Floseal worsens the long-term erectile function recovery in patients selected for nerve-sparing RALP. [ABSTRACT FROM AUTHOR]

Examples include a high-riding and/or dehiscent jugular bulb and a jugular bulb diverticulum. Given the close relationship of the jugular bulb with the hypotympanum, a high-riding or dehiscent jugular bulb can also complicate middle ear surgery, with injury leading to potentially serious bleeding. Keypoints Given the close relationship of the jugular bulb with the hypotympanum, a high-riding or dehiscent jugular bulb can complicate middle ear surgery, with injury leading to potentially serious bleeding. [Extracted from the article]

Objective To share our experience with a new delivery system for the flowable hemostatic matrix, FloSeal, in endoscopic and microscopic skull base surgery. Methods We prospectively analyzed the use of FloSeal with a hemostatic delivery system in transnasal endoscopic and microscopic skull base procedures performed at the authors' institution from January 1, 2015, to June 30, 2015. In all cases the number of aliquots was noted for the entire operation, and the total number of FloSeal ampules of 5 mL was also recorded. Results Our device allowed controlled application of small amounts (0.5–1 mL) of FloSeal to the site of bleeding. This controlled application resulted not only in increased visibility during its application, but it also reduced the amount of FloSeal required during the procedure. We were able to use 5–10 applications per 5-mL ampule of FloSeal within an individual procedure. No procedure required more than one 5-mL ampule of FloSeal. Therefore, the use of our device results in a reduction of costs. Prior to the use of our device, we were often only able to use 1 vial of 5 ml of material for 1 or 2 applications, especially in transnasal endoscopic procedures when working along a deep corridor. Conclusions Our results indicate that our delivery device of FlowSeal can effectively control hemostasis by applying small amounts of FlowSeal to the site of bleeding. This results in increased visibility during hemostasis and a reduction of cost. [ABSTRACT FROM AUTHOR]

Background: Perioperative bleeding is a potential complication of robot-assisted laparoscopic radical prostatectomy (RALP) that may worsen outcomes. The role of local hemostatic materials in RALP has not been adequately assessed. We evaluated the hemostatic impact of FloSeal (Baxter International Inc., Fremont, Calif., USA) in RALP. Methods: A retrospective analysis was performed of 392 consecutive patients with prostate cancer who underwent RALP at our institution between February 2008 and July 2014. The patients were divided into 2 consecutive homogenous groups based on the use of FloSeal. Group A included 200 patients who underwent RALP between February 2008 and May 2011, with hemostasis performed using only traditional techniques. Group B included the remaining 192 patients, who underwent RALP between June 2011 and July 2014 and received FloSeal 5 ml after traditional hemostatic methods. We compared the blood transfusion rate, the differences between immediate postoperative hemoglobin (Hb) and mean postoperative day 1 (POD1) Hb levels, difference between POD1 and least Hb levels and difference between immediate postoperative Hb and least Hb levels. Results: The intraoperative use of FloSeal significantly decreased the blood transfusions rate, from 8.5 to 2.1% (p = 0.004). FloSeal was also associated with significant improvements in the difference between the immediate postoperative Hb and POD1 Hb levels (p = 0.03), mean POD1 Hb and least Hb (p = 0.01) and mean immediate postoperative Hb and least Hb levels (p = 0.034). Conclusions: In this study, the use of FloSeal improves hemostatic outcomes in patients undergoing RALP compared with traditional hemostatic techniques, without increase of cost. [ABSTRACT FROM AUTHOR]

Introduction Accurate hemostasis in surgical practice is critical. The need for optimal atraumatic hemostasis has become compelling in neurosurgery. A simple and safe gelified hemostatic matrix is often used. This prospective study evaluates two different hemostatics, FloSeal (Baxter Healthcare, Deerfield, Illinois, United States) and Surgiflo (Ethicon, Somerville, New Jersey, United States), for bleeding control during spine surgery, considering their efficacy, safety, and ease of use. Materials and Methods From January 2012 to December 2013, we recruited 149 patients. Inclusion criteria were age between 25 and 80 years, diagnosis of degenerative or traumatic pathology of the lumbar or thoracolumbar spine, and persistent bleeding not responding to standard hemostatic techniques. All patients underwent laminectomy or laminoarthrectomy, with exposure of the perivertebral venous plexus. Our aim was to stop the bleeding completely in the operative field by application of hemostatic gel. All patients were evaluated during the follow-up period with a clinical and neurologic examination. All patients underwent a computed tomography scan 3 months after the intervention. Results We included 149 patients in our study: 98 men and 51 women. Overall, 92 patients were affected by a degenerative condition and 57 by traumatic pathology. A total of 42 patients had anticoagulant and/or antiaggregant therapy preoperatively. In all cases, massive bleeding originated from the epidural venous plexus. FloSeal was used in 86 cases and Surgiflo in 63. A complete hemostasis was achieved in all patients within 3 minutes, 30 seconds and 7 minutes (FloSeal, 5 minutes, 35 seconds ± 52 seconds; Surgiflo, 5 minutes, 32 seconds ± 54 seconds). Statistical analysis did not show any association between coagulation time and hemostatics, age, sex, and the pathology treated. Previous therapy with antiaggregants and/or anticoagulants determined a slight increase in the time of hemostasis without any statistical differences. The clinical and radiological follow-up showed no evidence of postsurgical hematomas. Conclusions Comparative analysis of the two products did not show any relevant differences in terms of efficacy and ease of use or their effectiveness in bleeding control. Their use was valid even in patients who used antiaggregant/anticoagulant drugs preoperatively. Both FloSeal and Surgiflo can be considered good choices for controlling bleeding in spinal surgery. [ABSTRACT FROM AUTHOR]

Background: Hemostasis during thyroidectomy is essential; however, the safest, most efficient, and most cost-effective way to achieve this is unclear. This randomized, multicenter, single-blind, prospective study evaluated the efficacy and safety of using different hemostatic approaches in patients undergoing total thyroidectomy.Methods: Patients aged ≥18 to 70 years were randomized to Floseal + a harmonic scalpel (HS), Floseal alone, HS alone, or standard total thyroidectomy. Primary endpoint was 24-hour drain output. Secondary endpoints included surgery duration and complications.Results: Two hundred and six patients were randomized to Floseal + HS (n = 52), Floseal alone (n = 54), HS alone (n = 50), and standard total thyroidectomy (n = 50). The 24-hour drain output was lower in the Floseal + HS group compared with standard thyroidectomy. Floseal + HS also had a shorter surgery time (P < .0001) versus the other 3 treatments.Conclusion: Floseal + HS can be effective at reducing postsurgical drain output and provides a complementary hemostatic approach in patients undergoing total thyroidectomy. [ABSTRACT FROM AUTHOR]

Purpose: The major complications of partial nephrectomy are bleeding and urine leakage. While various hemostatic agents are used to control bleeding, the histopathological characteristics of these hemostatic agents have not been investigated adequately. We aimed to investigate and compare the histopathological and hemostatic effects of local hemostatic agents in a partial nephrectomy rat model. Methods: Thirty-two rats were divided into four equal groups, and partial nephrectomy was done to all rats. Conventional suture repair, Glubran2, FloSeal, and Celox™ were applied to every single group. The period of warm ischemia and hemostasis during surgical process was timed. Rats were killed later 3 weeks, and their partial nephrectomy applied kidneys were evaluated histopathologically. Results: The fastest hemostasis was provided with Glubran2 (32.87 s). FloSeal was the second (40.85 s), and Celox™ was the third (55.75 s). Glomerular necrosis and calcification were seen more in the suture group than other groups ( p < 0.001). Fibrosis was found significantly less in Celox™ group. Fibroblast activation was found significantly less comparing to other groups ( p < 0.01). The erythrocyte aggregation was significantly greater in the Glubran2 and FloSeal groups than suture group ( p < 0.01 and p < 0.001). Conclusion: The negative effects of hemostatic agents to the renal histopathology were less than conventional suture repair. Celox™ was the best biocompatible agent. In comparison with three agents, it was observed that Glubran2 provided hemostasis faster than other agents. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery.Methods: This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient's group allocation.Results: Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0-4) vs. 1.9 ± 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study.Conclusions: This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery.Clinical Relevance: A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Background Surgical bleeding can be associated with an increased risk of morbidity and mortality across all surgical areas. Thus, numerous products have been developed to achieve haemostasis. A flowable haemostatic matrix such as Floseal® can quickly and reliably stop bleeding across the full spectrum of bleeding scenarios. The aim of this study was to systematically review clinical and economic evidence regarding the use of Floseal® in surgical procedures. Methods An extensive literature search was conducted in PubMed, EMBASE, and the Cochrane Library over the period spanning 2003-2013 to identify publications related to Floseal® use in all types of surgical procedures. Case reports and case series studies were excluded. Results A total of 27 papers met the selection criteria and were analysed. In the studies, blood loss and the time to achieve haemostasis were the most reported outcomes used to assess the efficacy of Floseal®. The majority of published studies (64%) examined the use of Floseal® compared with conventional methods (such as electrocautery or suturing). The remaining 36% of the studies evaluated the use of Floseal® compared with other haemostatic agents, such as Surgicel®, Gelfoam®, and Hemostase®. FloSeal® has been demonstrated to be an efficacious method in surgical procedures to reduce the time to achieve haemostasis, the frequency of intra- and postoperative bleeding, and the length of hospital stay, among other primary outcomes, resulting in less consumption of health resources. Conclusions The majority of the selected studies confirmed that Floseal® showed improvements over other haemostatic agents in achieving haemostasis and reducing blood loss. [ABSTRACT FROM AUTHOR]

Total knee arthroplasty (TKA) can be associated with substantial blood loss, leading to increased morbidity and transfusion rates. The study objective was to evaluate routine use of a thrombin-based topical hemostatic matrix in reducing blood loss and transfusion requirements in primary TKA. 108 patients were enrolled in a prospective, randomized, single-center trial. Patients receiving the hemostatic agent demonstrated a lower mean calculated blood loss (1325.2 ± 464.8 mL vs. control, 1509.3 ± 432.8 mL; P = 0.02), drain output (415.6 ± 202.0 mL vs. control, 579.9 ± 306.7 mL; P = 0.008), and length of stay (3.3 ± 0.8 days vs. control, 3.7 ± 1.1 days; P = 0.03), without a statistically significant difference in mean hemoglobin loss or transfusion requirements. The clinical utility of this hemostatic agent to reduce transfusions after uncomplicated, primary TKA continues to remain unclear. [ABSTRACT FROM AUTHOR]

Purpose: Laparoscopic salpingotomy has become the gold standard for the treatment of tubal ectopic pregnancy (TEP). Limitations for organ preservation in TEP can result from intra-operative bleeding or potential tubal damage due to application of thermal coagulation. Hemostatic gelatine-thrombin matrix Floseal allows effective local hemostasis when sutures or thermal coagulation are inadequate or impossible. Methods: We demonstrate in two cases how tubal preservation following effective hemostasis can be achieved by local application of gelatine-thrombin matrix. Results: In both cases, the ectopic pregnancy was localized in the ampullar part of the right tube, with gestational sac diameter of 38 and 15 mm, respectively, and visible embryos of 25 and 6.5 mm, respectively. After laparoscopic salpingotomy and evacuation of TEP, diffuse bleeding from the implantation site at the tubal wall was treated with the hemostatic matrix. Punctual bipolar coagulation was used only in Case 1 for striking bleeding from incision margins. Both patients were discharged without complications within 24-48 h after operation. Conclusions: Hemostatic gelatine-thrombin matrix Floseal minimizes tissue damage and optimizes local hemostasis. The use of Floseal enhances the chance of organ preservation in the laparoscopic treatment of TEP. [ABSTRACT FROM AUTHOR]

Background Platelet inhibitors are commonly used to reduce the risk of atherothrombotic events. The aim of this study was to determine the impact of platelet inhibitors, specifically clopidogrel and aspirin, on clot kinetics, strength, and/or structure during the use of thrombin based gelatin matrices and fibrin sealants. Methods Blood was collected and heparinized from donors on clopidogrel (and aspirin) and age matched control donors. Blood component analysis, whole blood platelet aggregometry, and activated clotting time (ACT) were used to monitor compliance to therapy and identify any differences between donor groups. Clot kinetics and strength were analyzed using thrombelastography (TEG). Field Emission Scanning Electron Microscopy (FESEM) was used to analyze clot structure. Results Blood component profiles were similar for both donor groups. Aggregometry indicated that aggregation response to adenosine diphosphate (ADP) for clopidogrel donors was 12% of that for the controls (p = 0.0021), an expected result of clopidogrel induced platelet inhibition. However, blood from both donor groups had an elevated thrombin induced aggregation response. Heparinization of donor blood resulted in similarly elevated ACTs for both donor groups. TEG results indicated similar clot kinetics and strength between clopidogrel and control donor groups for blood alone and when clotting was induced using thrombin based gelatin matrices and fibrin sealants. FESEM images supported TEG findings in that similar morphologies were observed in ex vivo formed clots from both donor groups when thrombin based gelatin matrices and fibrin sealants were used. Conclusion These results suggest that platelet inhibitors do not negatively impact clot kinetics, strength, and structure when clotting is initiated with thrombin based gelatin matrices and fibrin sealants. [ABSTRACT FROM AUTHOR]

Background: A novel live porcine model replicated the endoscopic surgical field of a carotid arterial injury of the human skull base. Hemostatic techniques were applied to jugular venous and carotid arterial injuries, including muscle patches, hemoclips, and aneurysm clips. Doppler imaging distal to the injury assessed flow through the repaired vessel. Materials and Methods: External jugular veins, and internal carotid arteries isolated from seven live anesthetized 100 kg pigs, were placed into a sinus model otorhino neuro trainer for visualization via an endoscopic nasal approach. Vessels were systematically injured and repaired, and Doppler measurements were made to assess flow through the vessels before injury and following repair. Results and Conclusions: Blood pressures were maintained within physiological ranges, despite blood losses of up to 4.5 l. Venous injuries were repaired using Floseal, hemoclips, and aneurysm clips, while arterial injuries were repaired with muscle patches and aneurysm clips. Blood flow remained in all vessels after repair. This porcine model was effective for demonstration of arterial and venous injuries during endoscopic skull base surgery. Crushed muscle patch was effective for arterial injuries of 3 mm, and the aneurysm clips for injuries of 5 mm. Jugular venous injuries of 3 mm were repaired using Floseal, 5 mm using hemoclips, and 6 mm using aneurysm clips. Doppler imaging was a noninvasive means of demonstrating ongoing flow through injured and repaired vessels. The model represents a valuable training tool with the potential to train endoscopic skull base teams the skills required to manage an internal carotid artery injury. [ABSTRACT FROM AUTHOR]

Background: Surgical hemostasis is achieved using adjunctive hemostats when conventional methods fail. Objective: This study compares the effectiveness of two adjunctive gelatin-thrombin hemostats. Hypothesis: To determine effectiveness, hemostats were compared in vivo, in vitro, and using scanning electron microscopy (SEM). Methods: In vivo, a heparinized porcine liver abrasion model was used to compare hemostatic success, degree of bleeding, and blood loss at 2, 5, and 10 minutes post-treatment. In vitro, thrombin in the supernatant of each hemostat and Red Blood Cells (RBC'S) in the supernatant of clots formed by each was compared. Results: Ultrastructure of one gelatin was smooth and the other stellate. In vivo, smooth gelatin provided superior hemostatic success at 5 (85% vs. 60%; OR: 5.3; 95% CI: 1.66 to 17.9) and 10 mins (72.5% vs. 47.5%; OR: 5.0; 95% CI: 1.55 to 16.1). Smooth gelatin had a statistically different degree of bleeding at 5 (0.58 ± 0.87 [Mean ± SD] vs. 1.03 ± 1.12; OR: 3.36; 95% CI: 1.34 to 8.41) and 10 mins (1.13 ± 1.14 vs. 1.65 ± 1.05; OR: 3.87; 95% CI: 1.62 to 9.21). Mean blood loss was less with smooth gelatin at 2 (0.07 ± 0.19 vs. 0.13 ± 0.63 ml/min), 5 (0.04 ± 0.13 vs. 0.23 ± 0.45 ml/min), and 10 mins (0.09 ± 0.24 vs. 0.21 ± 0.32 ml/min). In vitro, supernatant of smooth gelatin had significantly less thrombin (6.81 vs. 10.9 IU/ml, p = .001), and significantly less RBC's than stellate gelatin (0.07 vs. 0.09 × 106/ul, p = .0085). Conclusion: Smooth gelatin has an increased ability to retain thrombin and RBC's in vitro which may explain why it provides superior hemostatic effectiveness, superior control of bleeding, and greater reduced blood loss in vivo. [ABSTRACT FROM AUTHOR]

Aim: Bleeding during spine surgery is controlled using topical hemostatic agents. Studies have reported outcomes between Surgiflo ® and Floseal, the most widely used flowable hemostatic matrices, but have not included the latest Surgiflo formulation which is more adherent to the bleeding surface than prior formulations. Materials & methods: A propensity score-matched analysis was conducted using the Premier Healthcare Database to compare economic and clinical outcomes of adults undergoing inpatient spinal surgery between 2013 and 2018 receiving current Surgiflo or Floseal. Results: This retrospective study included 28,910 patients in each group and found comparable outcomes for bleeding events, overall transfusion rate, inpatient mortality and readmissions between Surgiflo and Floseal. Surgiflo was associated with $430 (USD) lower hospitalization costs, shorter length of stay and shorter operating room time than Floseal.

Abstract: Strict intra-operative haemostasis is essential in the practice of neurosurgery. Over the last century, haemostatic methods have advanced significantly and the modern surgeon is now faced with an array of haemostatic agents, each with subtly different qualities and proven in different contexts with various levels of evidence. The popularity of endoscopic and laparoscopic procedures in other surgical specialties has encouraged the introduction of novel agents to achieve haemostasis where conventional methods have proven difficult. These agents are beginning to find a role in routine use for surgery in both the elective and emergent settings. This article reviews the mechanisms of different haemostasis methods and the current evidence for their use in neurosurgery, with a focus on the more recently introduced gelatin-thrombin matrix sealant (Floseal® [Baxter, Hayward, CA, USA]). [Copyright &y& Elsevier]

Locally applied hemostatic agents, mostly consisting of gelatinous granules with admixed human or bovine thrombin, are used in various surgical procedures. In our case, a 78-year-old woman underwent neurosurgical removal of an extraforaminal schwannoma of the L5 dorsal root ganglion. During the procedure, the hemostatic matrix consisting of a meshwork of bovine gelatinous granules admixed with human thrombin was locally applied to control diffuse paravertebral bleeding. Eight hours after surgery, the patient developed dyspnea with right heart failure and finally died. At autopsy, we found complete occlusion of the left pulmonary artery with a large thromboembolus. Histologically, that thromboembolus consisted of gelatinous granules with only a thin rim of surrounding, classic parietal thrombus. To our knowledge, this is the first description of fatal pulmonary embolization of a major lung artery with this material. The report depicts a possible life-threatening complication associated with the local application of hemostatic agents. [ABSTRACT FROM AUTHOR]

The objective of this study was to evaluate the effect of FloSeal (FS, Baxter Healthcare, Deerfield, IL, USA) as a haemostatic matrix in comparison to bipolar electrocautery (EC) after tonsillectomy. Eligible patients were adults undergoing cold-knife tonsillectomy because of recurrent tonsillitis, tonsillar hypertrophy, or peritonsillar abscess (more than 3 months previously). Patients were randomly allocated, on a single-blind basis, to either FS or EC for haemostasis during tonsillectomy. Five experienced surgeons judged the handling of FS application using a five-point scale (very good, good, fair, poor, very poor). Postoperative pain scores were evaluated with a visual analogue scale for 20 days, and the duration under pain medication together with the consumption of pain medication was compared. Wound healing was documented on Days 1-5, 10, and 20. A total of 176 patients were enrolled. Overall, 76/77 (98.7%) of surgeon evaluations of FS handling were judged at least 'good'. FS-treated patients showed significantly improved wound healing (less thickness of wound plaques) throughout the postoperative observation period, a trend for less postoperative pain (cumulative pain intensity score; P = 0.074), and a significantly shorter duration of pain-medication use (9.5 vs. 11.6 days; P = 0.014) as well as reduced pain-medication consumption/demand ( P = 0.032). No difference in the rate of postoperative haemorrhage was observed between the two treatment groups (4.9% for FS patients, 6.0% for EC patients, P = 0.76). In conclusion, this study demonstrates the easy handling of FS application in tonsillectomy. Its use instead of EC after cold-steel tonsillectomy shows beneficial effects on mucosal recovery, as assessed by a decrease in the thickness of wound coating. Furthermore, FS is associated with a significantly shortened duration of pain-medication use and overall reduction in consumption/demand. [ABSTRACT FROM AUTHOR]