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

NCT00307515 | Completed Phase 3

• 1 other identifier: 400-05-006
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 16

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.

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Hemostatic success within 10 minutes.

  Intraoperative

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Fibrin Sealant 2 (FS2)

Drug: Fibrin Sealant 2 (FS2)

2

ACTIVE COMPARATOR

Oxidized Regenerated Cellulose (Surgicel)

Device: Oxidized Regenerated Cellulose (Surgicel)

Interventions

Fibrin Sealant 2 (FS2) DRUG

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

Also known as: CROSSEAL*, EVICEL*, tissue adhesive

1

Oxidized Regenerated Cellulose (Surgicel) DEVICE

Commercially available Surgicel used within label.

Also known as: Surgicel*

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead
• OMRIX Biopharmaceuticals: collaborator

Study Sites (16)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Miami Research Associates

Miami, Florida, 33173, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

The Iowa Clinic

Des Moines, Iowa, 50309, United States

Location

St. Agnes Healthcare, Inc.

Baltimore, Maryland, 21229, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

GYN Oncology Associates

Syracuse, New York, 13202, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Fibrin Tissue Adhesive; Tissue Adhesives

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• James Hart, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 23, 2006
• First Posted: March 28, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

US (16)