Trial Outcomes & Findings for Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH) (NCT NCT00742313)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

14 days

Results posted on

2014-03-05

Participant Flow

Subjects were recruited from Duke Hospital identified as undergoing endovein harvest of their saphenous vein.

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.

Participant milestones

Participant milestones
Measure	FloSeal Matrix FloSeal Matrix applied to EVH wound bed.	Non-FloSeal Matrix FloSeal Matrix was not added to the wound bed
Overall Study STARTED	25	19
Overall Study COMPLETED	24	19
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FloSeal n=25 Participants Arm A has FloSeal Matrix applied to EVH wound bed.	Control n=19 Participants Arm B does not have FloSeal Matrix applied to EVH wound bed.	Total n=44 Participants Total of all reporting groups
Age, Customized Greater than 18 years	25 Participants n=5 Participants	19 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	19 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Six participants were not analyzed due to early termination of study

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.

Outcome measures

Outcome measures
Measure	FloSeal Matrix n=25 Participants Arm A has FloSeal Matrix applied to EVH wound bed.	Control n=19 Participants Arm B does not have FloSeal Matrix applied to EVH wound bed.
Number of Participants With Decreased Bleeding	25 participants	19 participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Terry Ainsworth, Director, Clinical Research Operations, Education & Training

Duke University Medical Center

Phone: 919-681-7084

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place