U.S. Study of Fibrocaps in Surgical Hemostasis

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

October 31, 2011

Conditions
Postoperative Hemorrhage
Interventions
DEVICE

Fibrocaps (fibrin sealant)

Fibrocaps powder (max dose 1.5g) should be applied directly to the bleeding site or to the Gelfoam and then applied to the bleeding site. Re-application of 1.5 g of Fibrocaps is allowed.

DEVICE

Gelfoam

An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.

Trial Locations (1)

Unknown

Various sites, Indianapolis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY