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

Phase 4

Terminated

• Conditions: Bleeding
• Interventions: Biological: FloSeal Matrix

• Registration Number: NCT00742313
• Lead Sponsor: Duke University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2009-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-11
• Results First Submitted: 2013-11-08
• Results First Submitted QC: 2014-02-17
• Last Update Submitted: 2014-02-17
• Results First Posted: 2014-03-05
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Sign a consent form that has been approved by the Institutional Review Board.
2. Be at least 18 years of age.
3. Scheduled to undergo coronary artery bypass grafting with EVH.
4. Be able to return to Duke University Medical Center for post-operative visit.

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Exclusion Criteria

1. Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
2. Reported allergy to FloSeal Matrix™

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	FloSeal Matrix	Arm A has FloSeal Matrix applied to EVH wound bed.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Decreased Bleeding	14 days	The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States