search
Back to results

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

Primary Purpose

Blood Loss, Surgical

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fibrin Sealant 2 (FS2)
Oxidized Regenerated Cellulose (Surgicel)
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Los Angeles
  • Jacksonville Center for Clinical Research
  • Miami Research Associates
  • Medical College of Georgia
  • The Iowa Clinic
  • St. Agnes Healthcare, Inc.
  • Massachusetts General Hospital
  • Cooper University Hospital
  • Mt. Sinai Hospital
  • GYN Oncology Associates
  • Oregon Health and Science University
  • Lehigh Valley Hospital
  • Children's Hospital of Pittsburgh
  • Lankenau Hospital
  • MD Anderson Cancer Center
  • The Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Fibrin Sealant 2 (FS2)

Oxidized Regenerated Cellulose (Surgicel)

Outcomes

Primary Outcome Measures

Hemostatic success within 10 minutes.

Secondary Outcome Measures

Absence of bleeding at pre-defined time points within 10 minutes
Incidence of treatment failures
Incidence of potential bleeding-related complications
Adverse events

Full Information

First Posted
March 23, 2006
Last Updated
January 8, 2009
Sponsor
Ethicon, Inc.
Collaborators
OMRIX Biopharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00307515
Brief Title
Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ethicon, Inc.
Collaborators
OMRIX Biopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fibrin Sealant 2 (FS2)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Oxidized Regenerated Cellulose (Surgicel)
Intervention Type
Drug
Intervention Name(s)
Fibrin Sealant 2 (FS2)
Other Intervention Name(s)
CROSSEAL*, EVICEL*, tissue adhesive
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Oxidized Regenerated Cellulose (Surgicel)
Other Intervention Name(s)
Surgicel*
Intervention Description
Commercially available Surgicel used within label.
Primary Outcome Measure Information:
Title
Hemostatic success within 10 minutes.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Absence of bleeding at pre-defined time points within 10 minutes
Time Frame
Intraoperative
Title
Incidence of treatment failures
Time Frame
Intraoperative
Title
Incidence of potential bleeding-related complications
Time Frame
24 hr prior to discharge, Day 7-14
Title
Adverse events
Time Frame
Intraoperative, 24 hr prior to discharge, Day 7-14

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hart, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
The Iowa Clinic
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
St. Agnes Healthcare, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
GYN Oncology Associates
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs