Bleeding
Conditions
Keywords
Endoscopic, saphenous, vein, harvest
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.
Interventions
BIOLOGICALFloSeal Matrix
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Sponsors
Baxter Healthcare Corporation
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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™
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Decreased Bleeding | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from Duke Hospital identified as undergoing endovein harvest of their saphenous vein.
Pre-assignment details
Once subjects were enrolled,randomization occurred on the day of surgery. Only subject who's surgery did not occur as scheduled may have been screen failed.
Participants by arm
| Arm | Count |
|---|---|
| FloSeal Arm A has FloSeal Matrix applied to EVH wound bed. | 25 |
| Control Arm B does not have FloSeal Matrix applied to EVH wound bed. | 19 |
| Total | 44 |
Baseline characteristics
| Characteristic | FloSeal | Control | Total |
|---|---|---|---|
| Age, Customized Greater than 18 years | 25 Participants | 19 Participants | 44 Participants |
| Region of Enrollment United States | 25 participants | 19 participants | 44 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 24 Participants | 15 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 19 |
| serious Total, serious adverse events | 0 / 25 | 0 / 19 |
Outcome results
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.
Time frame: 14 days
Population: Six participants were not analyzed due to early termination of study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FloSeal Matrix | Number of Participants With Decreased Bleeding | 25 participants |
| Control | Number of Participants With Decreased Bleeding | 19 participants |