Blood Loss, Surgical
Conditions
Brief summary
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.
Detailed 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®.
Interventions
DRUGFibrin Sealant 2 (FS2)
FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
DEVICEOxidized Regenerated Cellulose (Surgicel)
Commercially available Surgicel used within label.
Sponsors
OMRIX Biopharmaceuticals
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostatic success within 10 minutes. | Intraoperative |
Secondary
| Measure | Time frame |
|---|---|
| Absence of bleeding at pre-defined time points within 10 minutes | Intraoperative |
| Incidence of treatment failures | Intraoperative |
| Incidence of potential bleeding-related complications | 24 hr prior to discharge, Day 7-14 |
| Adverse events | Intraoperative, 24 hr prior to discharge, Day 7-14 |
Countries
United States
Outcome results
None listed