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

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

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. Verisetâ„¢ 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 Verisetâ„¢ 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 Verisetâ„¢ hemostatic patch. Time to hemostasis was monitored, and adverse events were assessed during the 90 days after surgery. RESULTS When Verisetâ„¢ 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 Verisetâ„¢ hemostatic patch is a safe and effective hemostat for controlling soft tissue bleeding during a variety of surgical procedures.