1. Randomized clinical trial of BioFoam® Surgical Matrix to achieve hemostasis after liver resection
- Author
-
Nuh N. Rahbari, Jürgen Weitz, Dorothée Sturm, Emrullah Birgin, Uta Schwanebeck, and Christoph Reissfelder
- Subjects
medicine.medical_specialty ,Hepatic resection ,Blood Loss, Surgical ,030230 surgery ,Hemostatics ,law.invention ,Resection ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Clinical endpoint ,medicine ,Hepatectomy ,Humans ,Clinical significance ,Prospective Studies ,Hemostasis ,Hepatology ,business.industry ,Gastroenterology ,Hemostasis, Surgical ,Surgery ,Clinical trial ,Treatment Outcome ,Liver ,Topical agents ,030220 oncology & carcinogenesis ,business - 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 .
- Published
- 2020
- Full Text
- View/download PDF