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

Phase 3

Completed

• Conditions: Blood Loss, Surgical
• Interventions: Drug: Fibrin Sealant 2 (FS2); Device: Oxidized Regenerated Cellulose (Surgicel)

• Registration Number: NCT00307515
• Lead Sponsor: Ethicon, Inc.

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®.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-08
• Last Update Posted: 2009-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fibrin Sealant 2 (FS2)	Fibrin Sealant 2 (FS2)
2	Oxidized Regenerated Cellulose (Surgicel)	Oxidized Regenerated Cellulose (Surgicel)

Primary Outcome Measures

Name	Time	Method
Hemostatic success within 10 minutes.	Intraoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

St. Agnes Healthcare, Inc.; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

GYN Oncology Associates; 🇺🇸 Syracuse, New York, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Iowa Clinic; 🇺🇸 Des Moines, Iowa, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

Lankenau Hospital; 🇺🇸 Wynnewood, Pennsylvania, United States