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

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ClinicalTrials.gov Identifier: NCT00742313
Recruitment Status : Terminated (No statistical differences on study endpoints between groups.)
First Posted : August 27, 2008
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bleeding Biological: FloSeal Matrix Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Study Start Date : June 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A
Arm A has FloSeal Matrix applied to EVH wound bed.
Biological: FloSeal Matrix
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Other Name: FloSeal Hemostatic Matrix
No Intervention: Arm B
Arm B does not have FloSeal Matrix applied to EVH wound bed.



Primary Outcome Measures :
  1. Number of Participants With Decreased Bleeding [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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™

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00742313     History of Changes
Other Study ID Numbers: Pro00009897
First Posted: August 27, 2008    Key Record Dates
Results First Posted: March 5, 2014
Last Update Posted: March 5, 2014
Last Verified: November 2013

Keywords provided by Duke University:
Endoscopic
saphenous
vein
harvest

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Gelatin Sponge, Absorbable
Hemostatics
Coagulants