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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fibrin Sealant Vascular Surgery Study

NCT00576420

Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)

COMPLETED PHASE2

Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement

NCT00161902

Hip Replacement Surgery

COMPLETED PHASE3

FS VH S/D 500 S-apr in Vascular Surgery

NCT00892957

Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses

COMPLETED PHASE3

Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

NCT04457219

Injury; Blood Vessel, Wrist, Radial Artery

TERMINATED NA

Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

NCT00154141

Peripheral Vascular Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Arm A has FloSeal Matrix applied to EVH wound bed.

Group Type EXPERIMENTAL

FloSeal Matrix

Intervention Type BIOLOGICAL

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

Arm B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FloSeal Matrix

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FloSeal Hemostatic Matrix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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™

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No