Nuh N Rahbari1, Emrullah Birgin2, Dorothée Sturm3, Uta Schwanebeck4, Jürgen Weitz3, Christoph Reissfelder3. 1. Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany. Electronic address: nuh.rahbari@umm.de. 2. Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. 3. Department of Gastrointestinal, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany. 4. Coordination Center for Clinical Trials Dresden, Biostatistics, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Abstract
BACKGROUND: Topical agents were designed to facilitate hemostasis during hepatic resection. The aim of this prospective randomized controlled clinical trial was to evaluate the effectiveness and safety of BioFoam® Surgical Matrix for achieving hemostasis after open hepatic resection. METHODS: This was a prospective, randomized controlled monocentric trial of patients undergoing elective open liver resection between December 2015 and September 2017. The primary endpoint was time-to-complete hemostasis. RESULTS: A total of 101 patients were enrolled in this trial, giving 51 patients in the BioFoam® group and 50 patients in the control group (without use of BioFoam®). Time-to-complete hemostasis was significantly reduced in the BioFoam® group (156 ± 129 versus 307 ± 264 s; P = 0.001). There were no significant differences in postoperative bile leaks (n = 6 (12%) vs. n = 5 (10%); P = 0.776), postoperative morbidity (n = 37 (73%) vs. n = 40 (80%); P = 0.482) or mortality (n = 3 (6%) vs. n = 1 (2%); P = 0.618) between groups. CONCLUSION: BioFoam® is a safe topical agent for achieving faster hemostasis during hepatic resection, however, the true clinical relevance of this finding needs to be further evaluated. ClinicalTrials.gov ID NCT02612220.
BACKGROUND: Topical agents were designed to facilitate hemostasis during hepatic resection. The aim of this prospective randomized controlled clinical trial was to evaluate the effectiveness and safety of BioFoam® Surgical Matrix for achieving hemostasis after open hepatic resection. METHODS: This was a prospective, randomized controlled monocentric trial of patients undergoing elective open liver resection between December 2015 and September 2017. The primary endpoint was time-to-complete hemostasis. RESULTS: A total of 101 patients were enrolled in this trial, giving 51 patients in the BioFoam® group and 50 patients in the control group (without use of BioFoam®). Time-to-complete hemostasis was significantly reduced in the BioFoam® group (156 ± 129 versus 307 ± 264 s; P = 0.001). There were no significant differences in postoperative bile leaks (n = 6 (12%) vs. n = 5 (10%); P = 0.776), postoperative morbidity (n = 37 (73%) vs. n = 40 (80%); P = 0.482) or mortality (n = 3 (6%) vs. n = 1 (2%); P = 0.618) between groups. CONCLUSION: BioFoam® is a safe topical agent for achieving faster hemostasis during hepatic resection, however, the true clinical relevance of this finding needs to be further evaluated. ClinicalTrials.gov ID NCT02612220.
Authors: Emrullah Birgin; Arianeb Mehrabi; Dorothée Sturm; Christoph Reißfelder; Jürgen Weitz; Nuh N Rahbari Journal: World J Surg Date: 2021-05-28 Impact factor: 3.352