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

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307515
• Other study ID #: 400-05-006
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2006
• Last updated: January 8, 2009
• Start date: February 2006
• Est. completion date: December 2006

Study information

• Verified date: January 2009
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

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

Device:
• Oxidized Regenerated Cellulose (Surgicel)
Commercially available Surgicel used within label.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Medical College of Georgia	Augusta	Georgia
United States	St. Agnes Healthcare, Inc.	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	The Iowa Clinic	Des Moines	Iowa
United States	MD Anderson Cancer Center	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Miami Research Associates	Miami	Florida
United States	Mt. Sinai Hospital	New York	New York
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	GYN Oncology Associates	Syracuse	New York
United States	Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	OMRIX Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostatic success within 10 minutes.		Intraoperative	Yes
Secondary	Absence of bleeding at pre-defined time points within 10 minutes		Intraoperative	Yes
Secondary	Incidence of treatment failures		Intraoperative	Yes
Secondary	Incidence of potential bleeding-related complications		24 hr prior to discharge, Day 7-14	Yes
Secondary	Adverse events		Intraoperative, 24 hr prior to discharge, Day 7-14	Yes