Original articleAdult cardiacProspective, Randomized Clinical Trial of the FloSeal Matrix Sealant in Cardiac Surgery
Section snippets
Patients and Methods
The local Ethical Committee approved the study protocol and the patients enrolled in the study received full information, were willing to enter the trial, and provided written informed consent.
Study outcome measures included the following: rate of successful intraoperative hemostasis and time required for hemostasis; overall postoperative bleeding (as measured by chest tube output and indexed for body surface area); rate of transfusion of blood products both intraoperatively and in the
Results
Study design is summarized in Figure 1. The two study groups were comparable with respect to baseline characteristics as outlined in Table 1. Isolated coronary surgery was the most frequent category of operation performed, but more complex operations (combined coronary and valvular surgery) associated with prolonged cardiopulmonary bypass time, and aortic operations requiring systemic hypothermia were performed in a substantial amount of cases. Systemic hypothermia was indeed employed in 21% of
Comment
The primary objective of this study was to evaluate the intraoperative performance of the FloSeal hemostatic matrix as a topical hemostatic agent in a cohort of various primary cardiac operations. A key element of novelty with respect to the previously published studies is represented by the assessment of the immediate clinical course of the patients with respect to bleeding and bleeding-related complications. A wide variety of topical hemostatic agents have been developed so far, including
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