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

Christoph Schuhmacher, Johann Pratschke, Sascha Weiss, Stefan Schneeberger, André L Mihaljevic, Rebekka Schirren, Michael Winkler, Nikos Emmanouilidis, Christoph Schuhmacher, Johann Pratschke, Sascha Weiss, Stefan Schneeberger, André L Mihaljevic, Rebekka Schirren, Michael Winkler, Nikos Emmanouilidis

Abstract

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.

Figures

Figure 1
Figure 1
Subject flow. Notes: The total number of subjects that were screened and that consented to the study was 37. Of those, seven were screen failures. The other 30 subjects were treated with Veriset™ hemostatic patch and assessed according to the procedures in the Material and methods section of this article; however, one subject died (unrelated to use of the device) before the 7-day follow-up and another subject was lost to follow-up before the final 90-day postoperative assessment. Abbreviations: n, number of subjects; TBS, target bleeding site.
Figure 2
Figure 2
Kaplan–Meier analysis of time to hemostasis. Notes: After the application of Veriset™ hemostatic patch, hemostasis was assessed every 30 seconds for the first 5 minutes and every 1 minute for minutes 5–10. All subjects achieved hemostasis within 6.0 minutes, and only three subjects required longer than 2.0 minutes to achieve hemostasis.

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Source: PubMed

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