An international multidisciplinary peer-driven consensus on the optimal use of hemostatic powders in surgical practice

Abstract

Bleeding is a consequence of insufficient hemostasis and excessive bleeding at a surgical site is associated with an increased risk of post-operative infection, transfusion and re-operation, in addition to increased hospital length of stay and costs. Surgeons employ a range of methods to achieve hemostasis, including topical hemostatic agents of differing composition and properties. Hemostatic powders are a sub-group of topical hemostats, which can be used in helping as adjuncts to manage troublesome bleeding in a variety of situations. As this technology is relatively new and potentially not well known by the broad surgical community, no specific guidelines or recommendations for the optimal use of hemostatic powders in surgery currently exist. A steering group throughout Europe of multidisciplinary surgeons, expert in hemostasis and hemostatics, identified from literature and from personal experience, five key topics. When to use hemostatic powder, the evidence for use, benefits of use, safety remarks and considerations in various surgical specialties. Thirty-seven statements were subsequently drawn from these five key topics. An online survey was sent to 128 high-volume surgeons working in breast surgery, gynaecological and obstetric surgery, general and emergency surgery, thoracic surgery and urological surgery in Europe to assess agreement (consensus) with these statements. Consensus was defined as high if ≥ 75% and very high if ≥ 90% of respondents agreed with a statement. A total of 79 responses were received and consensus among the surgical experts was very high in 27 (73%) statements, high in 8 (22%) statements and was not achieved in 2 (5%) statements. Based on the consensus scores, the steering group produced 16 key recommendations which they considered could improve patient outcomes by reducing post-operative bleeding and its associated complications using hemostatic powder. Supplementary Information The online version contains supplementary material available at 10.1007/s13304-021-01136-x.

Use of polysaccharide hemostatic agent (HaemoCerTM) in breast cancer surgery to reduce postoperative complications: a randomized controlled trial

“…However, postoperative complications such as wound site infection or bleeding can often lead to discharge delays. While intraoperative control of bleeding remains pivotal for the reduction of postoperative complications, the application of topical hemostatic agents has become very common in the last two decades 18 . Specifically the effect of fibrin sealant containing human thrombin or combined hemostatic powder containing collagen, thrombin and chondroitin sulfate has been evaluated in the past, resulting in early drainage removal and increased day-case surgery 15,17,19 .…”

“…Postoperative complications like bleeding, wound site infection or seroma formation are however still sources for morbidity and are associated with hospital readmission and high health care costs [3][4][5] . During surgery, a delicate balance between bleeding and clotting has to be reached, in order to maintain tissue perfusion and to avoid postoperative bleeding, infections or tissues necrosis 6 . Studies conducted on the murine model have shown neoangiogenesis and fibrosis in the wound site after the application of local hemostatic agents, with no significant increase of tissue inflammation or necrosis 7 .…”

Topical haemostatics and sealants in gynaecological and obstetric surgery: state of the art

“…In general, patients may be at increased risk of bleeding for advanced age, decreased preoperative red blood cell volume (small body size and/or preoperative anaemia), medications affecting haemostasis, including complementary medicines, medical conditions causing haemostatic defect such hereditary bleeding disorders and acquired medical conditions like chronic kidney or liver disease, and high-risk procedures [14]. Furthermore, risk factors in any kind of surgery are previous surgery and extended and multiorgan resections, while gender, body mass index, and comorbidities including arterial hypertension, diabetes mellitus and renal dysfunction are independent risk factors for bleeding and transfusion [14,15]. A recent large retrospective cohort study in patients undergoing caesarean myomectomy for intramural leiomyoma, showed that the large size and lower segmental position of the leiomyoma are significantly risk factors for intraoperative haemorrhage during caesarean myomectomy [16].…”

Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery

“…12 – 14 Due to their ease of application, these agents have been adopted for widespread use in both open and minimally invasive abdominal surgeries. 15 , 16 While PSP was approved by the FDA for use in the US in 2006 and FSS in 1998, ORC was developed more recently and approved for use in 2017. 12 , 13 , 17 As a relatively new product, there is limited information on AEs reported with use of ORC in the literature.…”