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

Christoph Schuhmacher,1 Johann Pratschke,2 Sascha Weiss,2 Stefan Schneeberger,2 André L Mihaljevic,1 Rebekka Schirren,1 Michael Winkler,3 Nikos Emmanouilidis3 1Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 2Department...

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Autores principales:	Schuhmacher C, Pratschke J, Weiss S, Schneeberger S, Mihaljevic AL, Schirren R, Winkler M, Emmanouilidis N
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/38891819ebb8467087904e841576c7df
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spelling	oai:doaj.org-article:38891819ebb8467087904e841576c7df2021-12-02T01:58:07ZSafety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding1179-1470https://doaj.org/article/38891819ebb8467087904e841576c7df2015-03-01T00:00:00Zhttp://www.dovepress.com/safety-and-effectiveness-of-a-synthetic-hemostatic-patch-for-intraoper-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470 Christoph Schuhmacher,1 Johann Pratschke,2 Sascha Weiss,2 Stefan Schneeberger,2 André L Mihaljevic,1 Rebekka Schirren,1 Michael Winkler,3 Nikos Emmanouilidis3 1Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 2Department of Visceral, Transplant, and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria; 3Department of General, Visceral, and Transplantation Surgery, Hannover Medical School, Hannover, Germany Background: Continuous 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. Methods: Thirty 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. Results: When 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. Conclusions: Veriset™ hemostatic patch is a safe and effective hemostat for controlling soft tissue bleeding during a variety of surgical procedures. Keywords: Veriset™ hemostatic patch, hemostasis, topical hemostatSchuhmacher CPratschke JWeiss SSchneeberger SMihaljevic ALSchirren RWinkler MEmmanouilidis NDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2015, Iss default, Pp 167-174 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Schuhmacher C Pratschke J Weiss S Schneeberger S Mihaljevic AL Schirren R Winkler M Emmanouilidis N Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
description	Christoph Schuhmacher,1 Johann Pratschke,2 Sascha Weiss,2 Stefan Schneeberger,2 André L Mihaljevic,1 Rebekka Schirren,1 Michael Winkler,3 Nikos Emmanouilidis3 1Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 2Department of Visceral, Transplant, and Thoracic Surgery, Medical University of Innsbruck, Innsbruck, Austria; 3Department of General, Visceral, and Transplantation Surgery, Hannover Medical School, Hannover, Germany Background: Continuous 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. Methods: Thirty 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. Results: When 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. Conclusions: Veriset™ hemostatic patch is a safe and effective hemostat for controlling soft tissue bleeding during a variety of surgical procedures. Keywords: Veriset™ hemostatic patch, hemostasis, topical hemostat
format	article
author	Schuhmacher C Pratschke J Weiss S Schneeberger S Mihaljevic AL Schirren R Winkler M Emmanouilidis N
author_facet	Schuhmacher C Pratschke J Weiss S Schneeberger S Mihaljevic AL Schirren R Winkler M Emmanouilidis N
author_sort	Schuhmacher C
title	Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
title_short	Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
title_full	Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
title_fullStr	Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
title_full_unstemmed	Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
title_sort	safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/38891819ebb8467087904e841576c7df
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Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding

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