Artikel
A Multicenter, Randomized Clinical Trial Comparing the Veriset Hemostatic Patch with Fibrin Sealant for the Management of Bleeding During Hepatic Surgery
Suche in Medline nach
Autoren
-
Robert Öllinger
- Medizinische Universität Innsbruck, Visceral-, Transplantations- und Thoraxchirurgie, Innsbruck
-
Andre Mihaljevic
- Klinikum rechts der Isar, Technische Universität München, Department of Surgery, München
-
Christoph Schuhmacher
- , München
-
Hüseyin Bektas
- Medical School Hannover, Department of General, Visceral and Transplant Surgery, Hannover
-
Florian Vondran
- Medical School Hannover, Department of General, Visceral and Transplant Surgery, Hannover
-
Moritz Kleine
- Medical School Hannover, Department of General, Visceral and Transplant Surgery, Hannover
-
Mauricio Sainz-Barriga
- Ghent University Hospital Medical School, Department of General and Hepatobiliary Surgery, Liver Transplantation Service, Ghent
-
Sascha Weiss
- Medizinische Universität Innsbruck, Visceral-, Transplantations- und Thoraxchirurgie, Innsbruck
-
Phillip Knebel
- University Hospital Heidelberg, Department of General, Visceral, and Transplantation Surgery, Heidelberg
-
Roberto Troisi
- Ghent University Hospital Medical School, Department of General and Hepatobiliary Surgery, Liver Transplantation Service, Ghent
-
Johann Pratschke
- Medizinische Universität Innsbruck, Visceral-, Transplantations- und Thoraxchirurgie, Innsbruck
| Veröffentlicht: | 26. April 2013 |
|---|
Gliederung
Text
Introduction: Bleeding is a major concern in hepatic surgery, reduction thereof is time- and cost saving and beneficial to the patient. Topical hemostats are frequently used for diffuse parenchymal bleedings. Herein we compare a novel Hemostatic Patch, comprised of an absorbable backing made of oxidized cellulose and self adhesive hydrogel components (Veriset™) with an established fibrin sealant (TachoSil®).
Material and methods: 50 patients at 6 centers were included into this prospective, randomized, multi-center, single-blinded study. Patients underwent hepatic surgery according to the standard practices of each institution and were randomized to either Veriset™ (G1) or TachoSil® (G2), following confirmation of diffuse bleeding that could not be controlled with conventional measures from the hepatic resection surface requiring the use of a topical hemostat. Post application of either device, time to hemostasis was assessed at preset intervals until hemostasis was achieved. Subjects were followed for 30 days post procedure. Statistical analysis involved Kaplan Meier, log-rank and Fisher’s exact test.
Results: Both groups were similar in comorbidities, use of the Pringle maneuver, type of resection and cutting techniques. Both hemostyptics were successful in bleeding control in most of the cases (G1 93,8%; G2 88,9%). The median time to hemostasis (mTTH) for G1 was 1.0 minute compared to 3.0 minutes for G2 (p=0.0001). This result was independent of both the severity of bleed and area of the bleeding surface. Veriset™ and TachoSil® had similar safety profiles and no statistical differences were observed for adverse and device related events.
Conclusion: The Veriset™ Hemostatic Patch is as efficient as TachoSil® to achieve local hemostasis in patients undergoing hepatic resection. Veriset™ application results in a significantly faster time to hemostasis, thus it’s use should be considered for diffuse parenchymal bleedings during hepatic resections.
