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Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
This study is not yet open for participant recruitment.
Verified by Duke University, August 2008
Sponsors and Collaborators: Duke University
Baxter Healthcare Corporation
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00742313
  Purpose

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
Coronary Artery Bypass Grafting
Bleeding
Biological: FloSeal Matrix

MedlinePlus related topics: Coronary Artery Bypass Surgery Endoscopy
U.S. FDA Resources
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)

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Primary objective is to determine if using FloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein (EVH) will decrease bleeding from that site. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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
A, B
Arm A has FloSeal Matrix applied to EVH wound bed. Arm B does not have FloSeal Matrix applied to EVH wound bed.
Biological: FloSeal Matrix
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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™
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742313

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Baxter Healthcare Corporation
Investigators
Principal Investigator: James E Lowe, MD Duke University
  More Information

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

Keywords provided by Duke University:
Endoscopic
saphenous
vein
harvest

Study placed in the following topic categories:
Hemorrhage

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009