Effectiveness of Hemopatch® versus Surgicel® Original to control mild and moderate liver bleeding
Selman Uranues, Abraham Fingerhut, Eve Levin, Daniel Spazierer, Nastaran Rahimi, Bernhard Baumgartner
Abstract
Abstract Background Adjunct hemostats can be of use in certain surgical settings. We compared the effectiveness of two hemostats, Hemopatch® and Surgicel® Original in controlling bleeding from liver lesions in an experimental model. Methods Control of grades 1 (mild) and 2 (moderate) bleeding (according to the Validated Intraoperative Bleeding [VIBe] SCALE) was assessed for 10 min after Hemopatch® (n = 198) or Surgicel® Original (n = 199) application on 397 liver surface lesions. The primary endpoint was hemostatic success (reaching VIBe SCALE grade 0 at 10 min). The secondary endpoint was time to hemostasis (time to reach and maintain grade 0). A generalized linear mixed model and an accelerated failure time model were used to assess the primary and secondary endpoints, respectively. Results The overall hemostatic success rate of Hemopatch® was statistically significantly superior to that of Surgicel® Original (83.8% versus 73.4%; p = 0.0036; odds ratio [OR] 2.38, 95% confidence interval [CI] 1.33–4.27) and time to hemostasis was reduced by 15.9% (p = 0.0032; 95% CI 0.749–0.944). Grade 2 bleeds treated with Hemopatch® had statistically significantly higher hemostatic success (71.7% versus 48.5%; p = 0.0007; OR 2.97, 95% CI 1.58–5.58) and shorter time to hemostasis (49.6% reduction, p = 3.6 × 10 –8 ); differences for grade 1 bleeds (hemostatic success rate or time to hemostasis) were not statistically significant. Conclusions Hemopatch® provided better control of VIBe SCALE bleeding compared to Surgicel® Original for Grade 2 bleeds in this porcine model, highlighting the importance of choosing a suitable hemostat to optimize control of bleeding during surgery.