Evaluation of BioFoam for Anastomotic Bleeding in Cardiovascular Surgery.

ABSTRACT:

Background

 Hemostatic agents are increasingly used as an adjunct to standard methods of controlling anastomotic bleeding in surgical procedures. The purpose of this study was to investigate the safety and effectiveness of BioFoam Surgical Matrix used as an adjunct for anastomotic hemostasis following cardiovascular surgery.

Methods

 A prospective, multicenter, single arm study was conducted with 75 subjects treated with BioFoam following a total of 105 elective cardiovascular surgical procedures. Time to hemostasis was recorded following a single application of BioFoam in 74 subjects. Safety evaluations included intraoperative administration of a blood product, requirement for alternative means to achieve hemostasis, and the incidence of reoperation for bleeding.

Results

SUBMITTER: Alfieri O 

PROVIDER: S-EPMC6377360 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature