Ethicon Addresses Challenges of Surgical Bleeding to Help Surgeons Control Them More Efficiently and Reduce Impact on Patients

Ethicon Addresses Challenges of Surgical Bleeding to Help Surgeons Control Them More Efficiently and Reduce Impact on Patients

megadyneNorderstedt, Germany, November 26, 2020 – Ethicon, part of the Johnson & Johnson Medical Devices Companies, presented today a report on the burden of surgical bleeding and solutions to address it. This is part of the company’s ambition to raise awareness on occurrence and treatment of the bleeding categories posing the biggest challenges in surgery. Ethicon further announced two innovative products contributing to its comprehensive portfolio of adjunctive haemostats across Europe, Middle East and Africa (EMEA) markets: SURGICEL™ Powder Absorbable Haemostat and VERASEAL™ Fibrin Sealant (Human). The company constantly engages to address pressing unmet needs in surgery by education and innovation. 

As part of the company’s Burden of Bleeding program, today Ethicon presented the report: “Unpredicted, Underestimated, Unsettling: Surgical Bleeding”. It summarizes the impact of surgical bleeding for surgeons, patients, and hospitals alike. The panel of experts behind this report, Prof. Luca Aldrighetti (Italy), Prof. Nawwar Al-Attar (Scotland), Dr. Adam Brooks (England) and Prof. Santiago Domingo (Spain) address the need for appropriate handling strategies of the five surgical bleeding situations and illustrate the opportunities of novel haemostats.

“Reducing the burden of bleeding is an endeavour that starts before surgery and continues throughout the perioperative period. Correction of anaemia and preoperative optimization are key elements as is meticulous attention to surgical technique. Adjuncts, namely surgical haemostats and sealants can have a positive role in reducing the burden of bleeding. While there is great emphasis during surgical training on perfection of the surgical technique, the role and function of different surgical haemostats is less known and absent from most curricula.”, comments Prof. Nawwar Al-Attar.

An Ethicon study1 found that, when confronted with bleeding, surgeons consider the site and the situation as the primary factors in choosing which adjunctive haemostat to use. From the study and based on surgeons’ input, five categories emerged to describe the bleeding situations that surgeons encounter. These five bleeding situations are: continuous oozing, problematic bleeding, difficult-to-access bleeding, potential re-bleeding risk and high-pressure vessel bleeding.1 

“We are committed to educating our customers on why bleeding matters and address the various bleeding situations by equipping them with the right solutions to help achieve haemostasis efficiently. This report raises awareness for surgical bleeding situations to potentially reduce procedural costs and variability.” commented Ozgur Tomruk, Ethicon’s Biosurgery Lead for EMEA.

A study of more than 1.6 million surgeries showed that, on average, 29.9% of patients experienced some kind of complication related to bleeding. This figure rises to 47.4% for cardiac surgeries2. It was shown that, when bleeding is controlled, hospitals can optimize resources, especially in procedures like cardiac revascularization and cardiac valve surgery, where savings of $8,000 and $13,000 per procedure was seen3. Compared to primary methods of haemostasis alone, adjunctive haemostats have been associated with reduced use of hospital resources: up to 35% fewer patients require blood transfusions4,5,6,7,8,9; up to 4 days shorter length of hospital stay4,10; up to 25 minutes reduced operating time10,11 and significant reduction in the likelihood of hospital readmission12.

“At Ethicon we are constantly innovating to provide patients, clinicians, and hospitals with solutions that deliver improved clinical outcomes. With the aim to address the growing and wide-ranging challenges that surgeons face with surgical bleeding,  we expanded the SURGICEL family with SURGICEL™ Powder, for the management of the continuous oozing, and we are adding to our portfolio VERASEAL™, which helps preventing potential re-bleeding.”, said Tomruk.

Continuous oozing, one of the five major bleeding situations identified by the Ethicon study, does not stop with compression or simple packing1. The solution for this bleeding situation is more time consuming than it is difficult1. The research identified the oxidized regenerated cellulose (ORC) as the optimal choice of adjunctive haemostats for continuous oozing1. SURGICEL™ Powder contains an oxidized regenerated cellulose in powder form, which allows for efficient coverage of broad surfaces13

VERASEAL™ Fibrin Sealant (Human) is a fibrin sealant that is designed to help health care practitioners to prevent re-bleeding complications during surgery by providing a reliable fibrin clot independent of the patient’s coagulation profile14,15,i. The product is emerging from Ethicon’s partnership with Grifols, a pioneer in the field of plasma science. 


-End-

To learn more about Ethicon efforts to address surgical bleeding visit: https://www.jnjmedicaldevices.com/en-EMEA/campaign/Surgical-Bleeding-Adjunctive-Haemostasis-Optimisation-Program

To learn more about SURGICELTM Powder visit: https://www.jnjmedicaldevices.com/en-EMEA/product/surgicel-powder-absorbable-haemostat

About Ethicon 

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and adjunctive haemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit https://www.jnjmedicaldevices.com/en-EMEA/companies/ethicon

About the Johnson & Johnson Medical Devices Companies 

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

 

© Ethicon Endo-Surgery (Europe) GmbH 2020, 159282-201116 EMEA


i Reliable based on reproducible clot formation compared to control. Nenezic: Ratio of patient proportion meeting primary end point is 95% (P<0.001). Bjelovic: Rate of Hemostasis after 4 min is 92.4%. (137143-200416 EMEA)

1. Ferko, A systematic approach to surgical hemostat use supports standardization and cost efficiencies. Healthcare Purchasing News, 2017; ePub;1‐2 (119312‐190724 EMEA, 119313-190724 EMEA, 119327‐190724 EMEA)

2. Stokes ME, Ye X, Shah M, et al. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Services Research. 2011;11:135-148.  

3. Corral M, Hollmann S, Ferko N, et al. Health and economic consequences of controlled versus uncontrolled surgical bleeding in patients treated with haemostatic agents: a retrospective analysis of the premier perspective database. Poster presented at: Society for the Advancement of Blood Management. 2014 Annual Meeting; September, 2014; Houston, Texas.

4. Notarnicola A, Moretti L, Martucci A, Spinarelli A, Tafuri S, Pesce V, Moretti B. Comparative efficacyof different doses of fibrin sealant to reduce bleeding after total knee arthroplasty. Blood Coagul Fibrinolysis. 2012; 23 (4):278‐284. (117999‐190704 EMEA)

5. Molloy DO, Archbold HA, Ogonda L, McConway J, Wilson RK, Beverland DE. Comparison of topical fibrin spray and tranexamic acid on blood loss after total knee replacement: a prospective, randomised controlled trial. J Bone Joint Surg Br. 2007; 89 (3):306‐ 309. (117999‐190704 EMEA)

6. Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R. Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol. 2012; 13 (3):145‐151. (117999‐190704 EMEA)

7. Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg. 2001. 83‐A (10):1503‐1505. (117999‐190704 EMEA)

8. Randelli F, Banci L, Ragone V, Pavesi M, Randelli G. Effectiveness of fibrin sealant after cementless total hip
replacement: a doubleblind randomized controlled trial. Int J Immunopathol Pharmacol. 2013; 26 (1):189‐197. (117999‐190704 EMEA)

9. Joseph T, Adeosun A, Paes T, Bahal V. Randomised controlled trial to evaluate the efficacy of TachoComb
H Patches in Controllin PTFE Suture–hole Bleeding. Eur J Vasc Endovasc Surg. 2004; 27, 549–552. (117999‐190704 EMEA)

10. Dancey AL, Cheema M, Thomas SS (2010) A prospective randomized trial of the efficacy of marginal quilting sutures and fibrin sealant in reducing the incidence of seromas in the extended latissimus dorsi donor site. Plast Reconstr Surg 125 (5):1309‐1317. (117999‐190704 EMEA)

11. Pan HW, Zhong JX, Jing CX. Comparison of fibrin glue versus suture for conjunctival autografting in pterygium surgery: a meta‐analysis. Ophthalmology. 2011; 118 (6):1049‐1054. (117999‐190704 EMEA)

12. Ye X, Rupnow MF, Hammond J, Shah M, Farrelly E. Readmission rates and hospital costs associated with fibrin sealant use among patients undergoing orthopaedic surgery.J Orthopaedics.2012;9 (1) e11 (117999‐190704 EMEA)

13. Ethicon, Market Research on unmet need, Project Pixie Global Positioning Report, Dec 2014, Data on file. (079003-170822 EMEA)

14. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the efficacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections, J Gastrointest Surg:2018: 22:1939– 1949 (137157-200416 EMEA)

15. Nenezic, A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery, J of Vasc Surg, 2019;70;1642 (137157-200416)