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A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery


Phase 3
N/A
N/A
Not Enrolling
Both
Blood Loss, Surgical

Thank you

Trial Information

A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery


The time it will take to stop bleeding will be measured and compared between patients who
are treated with fibrin sealant 2 to those who are treated with Surgicel®.


Inclusion Criteria:



- Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal
surgical procedures

- Presence of an appropriate soft-tissue target bleeding site (challenging bleeding
site for which topical hemostatic adjuncts might typically be used) as identified
intra-operatively by the surgeon

- Subjects must be willing to participate in the study and provide written informed
consent

Exclusion Criteria:

- Subjects undergoing emergency surgery

- Parenchymal or anastomotic bleeding sites will not be considered for randomization

- Subjects with any intra-operative findings identified by the surgeon that may
preclude conduct of the study procedure

- Subjects with known intolerance to blood products or to one for the components of the
study product

- Subjects unwilling to receive blood products

- Subjects with known autoimmune immunodeficiency diseases (including known HIV

- Subjects who are known, current alcohol and/or drug abusers

- Subjects who have participated in another investigational drug or device research
study within 30 days of enrollment

- Female subjects who are pregnant or nursing

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hemostatic success within 10 minutes.

Outcome Time Frame:

Intraoperative

Safety Issue:

Yes

Principal Investigator

James Hart, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ethicon, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

400-05-006

NCT ID:

NCT00307515

Start Date:

February 2006

Completion Date:

December 2006

Related Keywords:

  • Blood Loss, Surgical
  • Hemorrhage
  • Blood Loss, Surgical

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Cooper University HospitalCamden, New Jersey  08103
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Medical College of GeorgiaAugusta, Georgia  30912
The Methodist HospitalHouston, Texas  77030
Oregon Health and Science UniversityPortland, Oregon  97201
Lankenau HospitalWynnewood, Pennsylvania  19096
St. Agnes Healthcare, Inc.Baltimore, Maryland  21229-5299
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
Mt. Sinai HospitalNew York, New York  10029
Children's Hospital of Los AngelesLos Angeles, California  90027
Miami Research AssociatesMiami, Florida  33173
The Iowa ClinicDes Moines, Iowa  50309
GYN Oncology AssociatesSyracuse, New York  13202