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

Study Overview
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Brief Summary
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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
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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®.

Official Title
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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

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Drug: Fibrin Sealant 2 (FS2)
* Device: Oxidized Regenerated Cellulose (Surgicel)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fibrin Sealant 2 (FS2) | Drug: Fibrin Sealant 2 (FS2)<br>* 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<br>* Other names: tissue adhesive;|
| Active Comparator: 2<br>Oxidized Regenerated Cellulose (Surgicel) | Device: Oxidized Regenerated Cellulose (Surgicel)<br>* Commercially available Surgicel used within label.<br>* Other names: Surgicel*;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic success within 10 minutes. |  | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |