Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding

Abstract

BackgroundContinuous bleeding after using conventional hemostatic methods involving energy, sutures, or clips, is a serious and costly surgical complication. Many topical agents have been developed to promote intraoperative hemostasis, but improvement is needed in both decreasing time to hemostasis and increasing ease of use. Veriset™ hemostatic patch is CE-marked for controlling bleeding on the liver and in soft tissue. In the current study, we aimed to gather further evidence for the safety and effectiveness of Veriset™ hemostatic patch in soft tissue bleeding during a variety of surgical procedures.MethodsThirty patients scheduled for nonemergency surgery, each with an intraoperative soft tissue bleeding site, were treated with Veriset™ hemostatic patch. Time to hemostasis was monitored, and adverse events were assessed during the 90 days after surgery.ResultsWhen Veriset™ hemostatic patch was used, hemostasis occurred within 5 minutes in 29/30 (96.7%) subjects and within 1 minute in 21/30 (70.0%) subjects. No device-related serious adverse events were recorded during the 30 days after surgery, and no reoperations for device-related bleeding complications were performed during the 5 days after surgery.ConclusionsVeriset™ hemostatic patch is a safe and effective hemostat for controlling soft tissue bleeding during a variety of surgical procedures.

Prospective, randomized, controlled, noninferiority clinical trial to evaluate the safety and efficacy of absorbable macroporous polysaccharide composites as adjunct to hemostasis during open surgery

“…The incidence of trial‐related AEs was only 1.8% and 1.2%. There was no treatment‐related SAE, which were similar to other intraoperative hemostatic study 30 . The majority of AEs reported in both groups in our study were either mild or moderate in severity and similar to those communicated in clinical trials using local hemostats on similar surgical procedures.…”

Use of hemostatic agents for surgical bleeding in laparoscopic partial nephrectomy: Biomaterials perspective

“…This study comprises excellent findings for further progress of LPN, even though it was performed in a small sample size, comparisons with other hemostatic methods are missing and the healing process was not followed up (Arkhipova et al, 2019). Despite the technological advancements and development of improved tools that lead to better surgical outcomes, energy‐based methods still hold unwanted problems, such as creating narcotic tissue and damage in the wound edges, increasing the propensity for infection (Dhillon, 2011; Guzzo et al, 2009; Louie et al, 2010; Msezane et al, 2008; Ritchie, Schuhmacher, Pratschke, et al, 2015). Besides, the majority of these techniques are applicable only to very specific cases and did not achieve a widespread clinical use (Sprunger & Herrell, 2005).…”

“…The latest generation of HAs consist on a synergistic combination of the structural material (i.e., the mechanical HA) and the biologically active substance(s). In addition, these innovative devices are now produced with different physical formats and adapted for different administration modes, characteristics that are detrimental for the effectiveness of the product in LPN context (Achneck et al, 2010; Chvapil, Owen, & DeYoung, 1983; Keshavarzi et al, 2013; Klingler et al, 2006; Lan et al, 2015; Lewis et al, 2014; Ritchie et al, 2015; Shukla, Fang, Puranam, Jensen, & Hammond, 2012; Wang et al, 2017). Vitagel™, for instance, is a third‐generation tissue glue that combines microfibrillar collagen and thrombin with the patient's own plasma, eliminating the risk of viral transmission.…”

“…As the number of products available grows in terms of both variability and complexity, questions about adverse reactions, inflammatory response, allergies and viral transmission arose, especially with devices containing animal‐derived products, such as bovine‐derived gelatin, human or animal‐derived thrombin, or human‐derived fibrinogen (Dimitroulis, Antoniou, Karidis, Kontzoglou, & Kouraklis, 2012; Msezane et al, 2008; Ritchie et al, 2015; Seyednejad et al, 2008). Even though, the evidences of significant tissue reactions are not worrying, there are some studies reporting adverse reactions when these products are not used in the recommended fashion (Barbolt, Odin, Léger, & Kangas, 2001; Chung, Menon, & Dillon, 1978; Msezane et al, 2008; Wahlstrom, 1983).…”

A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding

“…In two previous clinical trials, one in hepatic tissue and the other in soft tissue, no adverse events (AEs) related to Veriset™ hemostatic patch were reported, and quick control of bleeding was obtained. 7 , 8 In order to obtain clinical results on the device when applied to cardiovascular tissue, we performed a randomized, controlled, patient-blinded study comparing the safety and efficacy of Veriset™ hemostatic patch to that of TachoSil ® (Nycomed; Zürich, Switzerland) (currently approved for cardiovascular hemostasis), with a follow-up of 90 days post-surgery.…”