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Sponsors and Collaborators: |
Duke University Baxter Healthcare Corporation |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00742313 |
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.
Condition | Intervention |
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Coronary Artery Bypass Grafting Bleeding |
Biological: FloSeal Matrix |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH) |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A, B
Arm A has FloSeal Matrix applied to EVH wound bed. Arm B does not have FloSeal Matrix applied to EVH wound bed.
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Biological: FloSeal Matrix
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | James E Lowe, MD | Duke University |
Responsible Party: | Duke University Medical Center ( James E. Lowe, MD ) |
Study ID Numbers: | 00009897 |
Study First Received: | August 25, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00742313 |
Health Authority: | United States: Institutional Review Board |
Endoscopic saphenous vein harvest |
Hemorrhage |
Pathologic Processes |