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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bleeding

Intervention / Treatment
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* Biological: FloSeal Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign a consent form that has been approved by the Institutional Review Board. Be at least 18 years of age. Scheduled to undergo coronary artery bypass grafting with EVH. Be able to return to Duke University Medical Center for post-operative visit. Exclusion Criteria: Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study. Reported allergy to FloSeal Matrix™

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Arm A has FloSeal Matrix applied to EVH wound bed. | Biological: FloSeal Matrix<br>* 10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.<br>* Other names: FloSeal Hemostatic Matrix;|
| No Intervention: Arm B<br>Arm B does not have FloSeal Matrix applied to EVH wound bed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Decreased Bleeding | 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic, saphenous, vein, harvest