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

Primary Purpose

Bleeding

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FloSeal Matrix
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Endoscopic, saphenous, vein, harvest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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™

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A

Arm B

Arm Description

Arm A has FloSeal Matrix applied to EVH wound bed.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2008
Last Updated
February 17, 2014
Sponsor
Duke University
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00742313
Brief Title
Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Official Title
Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
No statistical differences on study endpoints between groups.
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
Endoscopic, saphenous, vein, harvest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Arm A has FloSeal Matrix applied to EVH wound bed.
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
Arm B does not have FloSeal Matrix applied to EVH wound bed.
Intervention Type
Biological
Intervention Name(s)
FloSeal Matrix
Other Intervention Name(s)
FloSeal Hemostatic Matrix
Intervention Description
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Primary Outcome Measure Information:
Title
Number of Participants With Decreased Bleeding
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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™
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Lowe, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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