A multi-center post-market clinical study to confirm safety and performance of PuraStat® in the management of bleeding during open 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:
05 2022
05 2022
Historique:
received:
20
07
2021
revised:
21
09
2021
accepted:
28
09
2021
pubmed:
23
10
2021
medline:
12
5
2022
entrez:
22
10
2021
Statut:
ppublish
Résumé
PuraStat® is a non-bioactive haemostatic agent that has demonstrated efficacy in a number of different surgical procedures. We performed a prospective multi-centre post-market study to evaluate the efficacy and safety of PuraStat® in liver resections performed for metastatic tumors. This was a prospective cohort study. Patients undergoing liver resection for metastatic tumor were screened for eligibility, and included if they were ≥18 years old, undergoing open liver resection, had normal liver function, and required application of PuraStat® for haemostasis where standard haemostatic techniques were either insufficient or impractical. The primary endpoint was "time to haemostasis" (TTH). Secondary endpoints included blood loss, total postoperative drainage volume, transfusion of blood products, and ease of use. Eighty patients were included for analysis in the intention to treat population. 207 bleeding sites were treated with PuraStat. Of these, 190 (91.7%) bleeding sites reached haemostasis after PuraStat® application. Mean TTH (mm:ss) was 1:01 (SD 1:06, range 0:09-6:55). Ease of use of the product was described as either "excellent" or "good" in 78 (98.8%) patients. No serious adverse events were identified. This study confirms the safety, efficacy and ease of use of PuraStat® in the management of bleeding in liver surgery.
Sections du résumé
BACKGROUND
PuraStat® is a non-bioactive haemostatic agent that has demonstrated efficacy in a number of different surgical procedures. We performed a prospective multi-centre post-market study to evaluate the efficacy and safety of PuraStat® in liver resections performed for metastatic tumors.
METHODS
This was a prospective cohort study. Patients undergoing liver resection for metastatic tumor were screened for eligibility, and included if they were ≥18 years old, undergoing open liver resection, had normal liver function, and required application of PuraStat® for haemostasis where standard haemostatic techniques were either insufficient or impractical. The primary endpoint was "time to haemostasis" (TTH). Secondary endpoints included blood loss, total postoperative drainage volume, transfusion of blood products, and ease of use.
RESULTS
Eighty patients were included for analysis in the intention to treat population. 207 bleeding sites were treated with PuraStat. Of these, 190 (91.7%) bleeding sites reached haemostasis after PuraStat® application. Mean TTH (mm:ss) was 1:01 (SD 1:06, range 0:09-6:55). Ease of use of the product was described as either "excellent" or "good" in 78 (98.8%) patients. No serious adverse events were identified.
CONCLUSION
This study confirms the safety, efficacy and ease of use of PuraStat® in the management of bleeding in liver surgery.
Identifiants
pubmed: 34674951
pii: S1365-182X(21)01649-X
doi: 10.1016/j.hpb.2021.09.020
pii:
doi:
Substances chimiques
Hemostatics
0
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
700-707Informations de copyright
Copyright © 2021 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.