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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00742313
• Other study ID #: Pro00009897
• Status: Terminated
• Phase: Phase 4
• First received: August 25, 2008
• Last updated: February 17, 2014
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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™

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Biological:
• FloSeal Matrix
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No