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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Fibrin Sealant 2 (FS2); Device: Oxidized Regenerated Cellulose (Surgicel)

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®.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miami, Florida, United States, 33173
      • Miami Research Associates
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • The Iowa Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Healthcare, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai Hospital
    • Syracuse, New York, United States, 13202
      • GYN Oncology Associates
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Pittsburgh, Pennsylvania, United States, 15206
      • Children's Hospital of Pittsburgh
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Fibrin Sealant 2 (FS2)	Drug: Fibrin 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; Other Names: tissue adhesive; CROSSEAL*; EVICEL*
Active Comparator: 2; Oxidized Regenerated Cellulose (Surgicel)	Device: Oxidized Regenerated Cellulose (Surgicel); Commercially available Surgicel used within label.; Other Names: Surgicel*

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemostatic success within 10 minutes.	Intraoperative

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Collaborators: OMRIX Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: March 23, 2006
• First Submitted That Met QC Criteria: March 27, 2006
• First Posted (Estimate): March 28, 2006

Study Record Updates

• Last Update Posted (Estimate): January 9, 2009
• Last Update Submitted That Met QC Criteria: January 8, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: 400-05-006