The Fibrin Patch Soft Tissue Study

Study Overview
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Brief Summary
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The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Official Title
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A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

Conditions
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Hemostasis

Intervention / Treatment
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* Drug: Fibrin Pad
* Device: SURGICEL™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon Subjects must be willing to participate in the study, and provide written informed consent Exclusion Criteria: Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure Subject with TBS within an actively infected field Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine Subjects with known intolerance to blood products or to one of the components of the study product Subjects unwilling to receive blood products Subjects with 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

Ages Eligible for Study
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Minimum Age: 18 Years

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> | Drug: Fibrin Pad<br>* Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).<br>|
| Active Comparator: 2<br>SURGICEL™ Absorbable Hemostat | Device: SURGICEL™<br>* Absorbable hemostat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Hemostatic Success | Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving Hemostatic Success | The proportion of subjects achieving hemostatic success at 10 minutes following randomization | 10 minutes | 
| Incidence of Treatment Failures | If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure. | Intra-operative | 
| Incidence of Adverse Events That Are Potentially Related to Bleeding | The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS). | Intra-operative up to 1 month (+14 days) | 
| Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism | Intra-operative up to 1 month (+14 days) | 
| Incidence of Adverse Events Potentially Related to Transfusion Exposure | The types of events that were potentially related to transfusion exposure could have include hypocalcemia. | Intra-operative up to 1 month (+14 days) | 
| Incidence of Re-treatment | The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period. In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment. | Intra-operative | 
| Incidence of Adverse Events |  | 30 days (+14 days) |