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 Hemostasis within 3 minutes was achieved in 62 (84%) of the 74 subjects and within
10 minutes in 69 (93%) of these subjects. BioFoam was well tolerated. Twelve (16%)
of the 75 enrolled subjects each experienced one adverse event, and 13 serious adverse
events were reported in 10 (13.3%) of the subjects. None of the adverse events was
considered by the Investigators to be related to BioFoam. Blood products were administered
to 14 (18.6%) of the 75 subjects, banked autologous blood was given to 5 (6.6%) subjects,
and 57 (75.7%) subjects required only a cell saver. Four (5.3%) of the 75 subjects
required reoperation for bleeding within 24 hours of surgery. There were no observations
of bleeding in any subject at discharge and no reoperation for bleeding following
discharge. The mean operation time was 218.2 (±72.2) minutes.
Conclusions This study demonstrates the effectiveness of BioFoam Surgical Matrix when used as
an adjunct for anastomotic hemostasis following a broad range of cardiovascular surgical
procedures. The safety outcomes were within the normal limits for the types of procedures
performed.
Keywords
BioFoam - hemostatic agent - surgical sealant - cardiovascular surgery
