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

Duke University

Status and phase: Terminated; Phase 4

Conditions: Bleeding

Treatments: Biological: FloSeal Matrix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00742313

Pro00009897

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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™

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Arm A

Experimental group

Description:

Arm A has FloSeal Matrix applied to EVH wound bed.

Treatment:

Biological: FloSeal Matrix

Arm B

No Intervention group

Description:

Arm B does not have FloSeal Matrix applied to EVH wound bed.