A Phase 4 interventional study of FloSeal Matrix in Bleeding, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-05.
Sponsored by Duke University · Phase 4, Interventional, and Treatment
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm A has FloSeal Matrix applied to EVH wound bed.
Biological: FloSeal Matrix
Arm B does not have FloSeal Matrix applied to EVH wound bed.
10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Also known as: FloSeal Hemostatic Matrix
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
Subjects were recruited from Duke Hospital identified as undergoing endovein harvest of their saphenous vein.
| Milestone | FloSeal Matrix | Non-FloSeal Matrix |
|---|---|---|
| Started | 25 | 19 |
| Completed | 24 | 19 |
| Not completed | 1 | 0 |
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.
| participants | FloSeal Matrix | Control |
|---|---|---|
| Number of Participants With Decreased Bleeding | 25 | 19 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A | — | 0/25 (0%) | 0/25 (0%) |
| Arm B | — | 0/19 (0%) | 0/19 (0%) |
| Age, Customized(Participants) | FloSeal | Control | Total |
|---|---|---|---|
| Greater than 18 years | 25 | 19 | 44 |
| Sex: Female, Male(Participants) | FloSeal | Control | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 24 | 15 | 39 |
| Region of Enrollment(participants) | FloSeal | Control | Total |
|---|---|---|---|
| United States | 25 | 19 | 44 |
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Duke University