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      Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations

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          Abstract

          Aim

          This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations.

          Methods

          Patients meeting eligibility criteria were enrolled after providing informed consent. Subjects were randomized intraoperatively to receive CP (HEMOBLAST Bellows; Biom'up, France) or HM (FLOSEAL Hemostatic Matrix; Baxter Healthcare Corporation, Hayward, CA). Bleeding was assessed using a clinically validated, quantitative bleeding severity scale. The primary endpoint was total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis was achieved. TTTH at 3 minutes was utilized for the primary analysis, while TTTH at 5 minutes was considered as a secondary endpoint.

          Results

          A total of 105 subjects were enrolled across four institutions. The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%‐71.6%; P < .001 for superiority). The secondary efficacy endpoint was also met, with 92.5% of the CP group achieving hemostasis at 5 minutes versus 44.2% in the HM group, a difference of 48.2% (31.1%‐65.4%; P < .001 for noninferiority). There were no device‐related adverse events.

          Conclusions

          In this multicenter, randomized, controlled trial, comparison of CP to HM revealed CP superiority and noninferiority for TTTH at 3 and 5 minutes, respectively.

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          Most cited references16

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          Understanding Costs of Care in the Operating Room

          Importance Increasing value requires improving quality or decreasing costs. In surgery, estimates for the cost of 1 minute of operating room (OR) time vary widely. No benchmark exists for the cost of OR time, nor has there been a comprehensive assessment of what contributes to OR cost. Objectives To calculate the cost of 1 minute of OR time, assess cost by setting and facility characteristics, and ascertain the proportion of costs that are direct and indirect. Design, Setting, and Participants This cross-sectional and longitudinal analysis examined annual financial disclosure documents from all comparable short-term general and specialty care hospitals in California from fiscal year (FY) 2005 to FY2014 (N = 3044; FY2014, n = 302). The analysis focused on 2 revenue centers: (1) surgery and recovery and (2) ambulatory surgery. Main Outcomes and Measures Mean cost of 1 minute of OR time, stratified by setting (inpatient vs ambulatory), teaching status, and hospital ownership. The proportion of cost attributable to indirect and direct expenses was identified; direct expenses were further divided into salary, benefits, supplies, and other direct expenses. Results In FY2014, a total of 175 of 302 facilities (57.9%) were not for profit, 78 (25.8%) were for profit, and 49 (16.2%) were government owned. Thirty facilities (9.9%) were teaching hospitals. The mean (SD) cost for 1 minute of OR time across California hospitals was $37.45 ($16.04) in the inpatient setting and $36.14 ($19.53) in the ambulatory setting ( P  = .65). There were no differences in mean expenditures when stratifying by ownership or teaching status except that teaching hospitals had lower mean (SD) expenditures than nonteaching hospitals in the inpatient setting ($29.88 [$9.06] vs $38.29 [$16.43]; P  = .006). Direct expenses accounted for 54.6% of total expenses ($20.40 of $37.37) in the inpatient setting and 59.1% of total expenses ($20.90 of $35.39) in the ambulatory setting. Wages and benefits accounted for approximately two-thirds of direct expenses (inpatient, $14.00 of $20.40; ambulatory, $14.35 of $20.90), with nonbillable supplies accounting for less than 10% of total expenses (inpatient, $2.55 of $37.37; ambulatory, $3.33 of $35.39). From FY2005 to FY2014, expenses in the OR have increased faster than the consumer price index and medical consumer price index. Teaching hospitals had slower growth in costs than nonteaching hospitals. Over time, the proportion of expenses dedicated to indirect costs has increased, while the proportion attributable to salary and supplies has decreased. Conclusions and Relevance The mean cost of OR time is $36 to $37 per minute, using financial data from California’s short-term general and specialty hospitals in FY2014. These statewide data provide a generalizable benchmark for the value of OR time. Furthermore, understanding the composition of costs will allow those interested in value improvement to identify high-yield targets. This cross-sectional analysis of annual financial disclosure documents calculates the cost of 1 minute of operating room time, assesses cost by setting and facility characteristics, and ascertains the proportion of costs that are direct and indirect. Questions What is the cost of 1 minute of operating room time, and what contributes to this cost? Findings In this cross-sectional analysis, the mean cost of operating room time in fiscal year 2014 for California’s acute care hospitals was $36 to $37 per minute; $20 to $21 of this amount is direct cost, with $13 to $14 attributable to wages and benefits and $2.50 to $3.50 attributable to surgical supplies. Meaning These numbers are the first standardized estimates of operating room cost; understanding the composition of costs will allow those interested in value improvement to identify high-yield targets.
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            Hemostats, sealants, and adhesives: components of the surgical toolbox.

            The surgical toolbox is expanding, and newer products are being developed to improve results. Reducing blood loss so that bloodless surgery can be performed may help minimize morbidity and length of stay. As patients, hospital administrators, and government regulators desire less invasive procedures, the surgical technical challenge is increasing. More operations are being performed through minimally invasive incisions with laparoscopic, endoscopic, and robotic approaches. In this setting, tools that can reduce bleeding by causing blood to clot, sealing vessels, or gluing tissues are gaining an increasing importance. Thus, hemostats, sealants, and adhesives are becoming a more important element of surgical practice. This review is designed to facilitate the reader's basic knowledge of these tools so that informed choices are made for controlling bleeding in specific clinical situations. Such information is useful for all members of the operative team. The team includes surgeons, anesthesiologists, residents, and nurses as well as hematologists and other medical specialists who may be involved in the perioperative care of surgical patients. An understanding of these therapeutic options may also be helpful to the transfusion service. In some cases, these materials may be stored in the blood bank, and their appropriate use may reduce demand for other transfusion components. The product classification used in this review includes hemostats as represented by product categories that include mechanical agents, active agents, flowables, and fibrin sealants; sealants as represented by fibrin sealants and polyethylene glycol hydrogels; and adhesives as represented by cyanoacrylates and albumin cross-linked with glutaraldehyde. Only those agents approved by the Food and Drug Administration (FDA) and presently available (February 2008) for sale in the United States are discussed in this review.
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              Clinical benefits and risk analysis of topical hemostats: a review.

              A variety of local hemostats including absorbable gelatin sponge, collagen hemostat, and oxidized cellulose are commercially available. Local hemostats are applied when cautery, ligature, or other conventional hemostatic method is impractical. Proper handling is essential to control bleeding and only the required amount should be used, even though the hemostat is expected to dissolve promptly. A dry local hemostat absorbs body fluid of several times its own weight and expands postoperatively. Therefore, when an absorbable hemostatic agent is retained on or near bony or neural spaces, the minimum amount should be left after hemostasis is achieved. Documentation is important with regard to the hemostat used, including the name of the agent, site, and amount. This information is used as a reference in the interpretation of postoperative diagnostic images, since retained hemostat may sometimes mimic an abscess or recurrent tumor. The antigenicity of collagen is known to be low because of homology. When the safety of collagen was evaluated, the incidence of positive reactions was reported as 3.0%, and collagen may cause allergic reactions. Minimum inflammation without strong foreign body reactions or blockade of healing is desirable after the use of local hemostats. Strong foreign body reactions, chronic inflammation, and infections can cause granuloma formation after local hemostat use. By using local hemostats, it is possible to improve the condition of the patient, reduce complications, and lower direct and indirect costs.
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                Author and article information

                Contributors
                wspotnitz@gmail.com
                Journal
                J Card Surg
                J Card Surg
                10.1111/(ISSN)1540-8191
                JOCS
                Journal of Cardiac Surgery
                John Wiley and Sons Inc. (Hoboken )
                0886-0440
                1540-8191
                25 November 2019
                February 2020
                : 35
                : 2 ( doiID: 10.1111/jocs.v35.2 )
                : 313-319
                Affiliations
                [ 1 ] Department of Surgery Kaiser Moanalua Medical Center Honolulu Hawaii
                [ 2 ] Department of Surgery University of California at Los Angeles Los Angeles California
                [ 3 ] Methodist DeBakey Heart and Vascular Center Houston Methodist Hospital Houston Texas
                [ 4 ] Thoracic and Cardiovascular Surgery Section Ochsner Medical Center New Orleans Louisiana
                [ 5 ] Department of Statistics University of California Irvine California
                [ 6 ] Biom'up SA Lyon France
                [ 7 ] Department of Surgery Duke University Durham North Carolina
                [ 8 ] Department of Mechanical Engineering and Materials Science Duke University Durham North Carolina
                [ 9 ] Department of Surgery University of Virginia Charlottesville Virginia
                Author notes
                [*] [* ] Correspondence William D. Spotnitz, MD, 2738 SW 92nd Drive, Gainesville, FL 32608.

                Email: wspotnitz@ 123456gmail.com

                Author information
                http://orcid.org/0000-0002-0263-5128
                Article
                JOCS14376
                10.1111/jocs.14376
                7003826
                31763732
                4d4d93fe-91b4-4e23-b43b-76e3a426ebfc
                © 2019 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                Page count
                Figures: 1, Tables: 6, Pages: 7, Words: 3891
                Funding
                Funded by: Biom'up SA
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                February 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:06.02.2020

                bleeding scale,collagen,hemostat,hemostatic agent,hemostatic combination powder,thrombin

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