Bleeding Clinical Trial
Official title:
Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
This is a prospective, randomized trial to see in patients undergoing coronary artery bypass grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.
Purpose of Study: The primary objective of this study is to determine if using a hemostatic
agent (FloSeal Matrix™) in the tunnel of the endoscopically harvested Greater Saphenous vein
will decrease bleeding from that site. Secondary objectives are to determine if there is a
decrease in the infection-rate at the site of the vein-harvested leg where the FloSeal
Matrix™ was used compared to the ones where FloSeal Matrix™ was not used.
Background and Significance: FloSeal Matrix™ is indicated in surgical procedures (other than
ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional
procedures is ineffective or impractical. It works on wet, actively bleeding tissue and
conforms to irregular wound surfaces. It is proven to control bleeding from oozing to
pulsatile flow. The EVH wound bed is irregular and hemostasis is, at times, difficult to
obtain using conventional procedures such as ligature or cautery.
Design and Procedures: This is a prospective, randomized clinical trial that compares the
effects of applying FloSeal Matrix™ to the EVH wound bed to not applying FloSeal Matrix™ to
the EVH wound bed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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