Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery

Ethicon

Status and phase

Completed

Phase 3

Conditions

Blood Loss, Surgical

Treatments

Drug: Fibrin Sealant 2 (FS2)

Device: Oxidized Regenerated Cellulose (Surgicel)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00307515

400-05-006

Details and patient eligibility

About

A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

Full description

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®.

Enrollment

135 patients

Sex

All

Volunteers

No Healthy Volunteers

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