Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
Blood Loss, Surgical
About this trial
This is an interventional treatment trial for Blood Loss, Surgical
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Los Angeles
- Jacksonville Center for Clinical Research
- Miami Research Associates
- Medical College of Georgia
- The Iowa Clinic
- St. Agnes Healthcare, Inc.
- Massachusetts General Hospital
- Cooper University Hospital
- Mt. Sinai Hospital
- GYN Oncology Associates
- Oregon Health and Science University
- Lehigh Valley Hospital
- Children's Hospital of Pittsburgh
- Lankenau Hospital
- MD Anderson Cancer Center
- The Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Fibrin Sealant 2 (FS2)
Oxidized Regenerated Cellulose (Surgicel)