NCT00742313

Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	FloSeal Matrix	10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2008-08-27
• Last updated: 2014-03-05
• Results posted: 2014-03-05

Locations

1 site across 1 country: United States