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No statistical differences on study endpoints between groups.
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Arm A has FloSeal Matrix applied to EVH wound bed. |
|
| Arm B | No Intervention | Arm B does not have FloSeal Matrix applied to EVH wound bed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloSeal Matrix | Biological | 10 ml of FloSeal Matrix will be applied to the endoscopic wound bed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E Lowe, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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.
Subjects were recruited from Duke Hospital identified as undergoing endovein harvest of their saphenous vein.
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| ID | Title | Description |
|---|---|---|
| FG000 | FloSeal Matrix | FloSeal Matrix applied to EVH wound bed. |
| FG001 | Non-FloSeal Matrix | FloSeal Matrix was not added to the wound bed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FloSeal | Arm A has FloSeal Matrix applied to EVH wound bed. |
| BG001 | Control | Arm B does not have FloSeal Matrix applied to EVH wound bed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Six participants were not analyzed due to early termination of study | Posted | Number | participants | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Arm A has FloSeal Matrix applied to EVH wound bed. |
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This study was terminated early
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry Ainsworth, Director, Clinical Research Operations, Education & Training | Duke University Medical Center | 919-681-7084 | terry.ainsworth@duke.edu |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C411004 | FloSeal Matrix |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Arm B | Arm B does not have FloSeal Matrix applied to EVH wound bed. | 0 | 19 | 0 | 19 |
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