Randomized clinical trial of BioFoam® Surgical Matrix to achieve hemostasis after liver resection.
Journal
HPB : the official journal of the International Hepato Pancreato Biliary Association
ISSN: 1477-2574
Titre abrégé: HPB (Oxford)
Pays: England
ID NLM: 100900921
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
09
09
2019
revised:
04
10
2019
accepted:
13
10
2019
pubmed:
5
11
2019
medline:
26
10
2021
entrez:
5
11
2019
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 31680010
pii: S1365-182X(19)32271-3
doi: 10.1016/j.hpb.2019.10.1529
pii:
doi:
Substances chimiques
Hemostatics
0
Banques de données
ClinicalTrials.gov
['NCT02612220']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
987-995Informations de copyright
Copyright © 2019 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.