Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries

PHASE3CompletedINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

April 30, 2015

Study Completion Date

June 30, 2015

Conditions
Soft Tissue Surgical Bleeding
Interventions
BIOLOGICAL

Fibrin Sealant (FS) Grifols

Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).

DEVICE

Surgicel®

Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.

Trial Locations (25)

1082

702, Budapest

4031

701, Debrecen

4032

700, Debrecen

703, Debrecen

9023

704, Győr

10016

305, New York

11000

720, 722, 726, 723, Belgrade

12208

327, Albany

12601

332, Poughkeepsie

15224

307, Pittsburgh

18000

725, Niš

21000

721, 724, Novi Sad

27157

304, Winston-Salem

29425

325, Charleston

33472

321, Boynton Beach

35630

407, Florence

37403

331, Chattanooga

38613

314, Memphis

55905

312, Rochester

63110

300, St Louis

77024

402, Houston

77030

316, Houston

91105

320, 322, 323, Pasadena

98431

405, Tacoma

06606

404, Bridgeport

All Listed Sponsors
collaborator

Instituto Grifols, S.A.

INDUSTRY

lead

Grifols Biologicals, LLC

INDUSTRY

NCT01731938 - Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries | Biotech Hunter | Biotech Hunter