Effect on Bleeding When Using FloSeal Matrixâ„¢ in Subjects Undergoing Endoscopic Vein Harvest (EVH)



Status:Archived
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2009

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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 Matrixâ„¢) 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
Matrixâ„¢ was used compared to the ones where FloSeal Matrixâ„¢ was not used.

Background and Significance: FloSeal Matrixâ„¢ 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 Matrixâ„¢ to the EVH wound bed to not applying FloSeal Matrixâ„¢ to
the EVH wound bed.


We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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from
Durham, NC
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