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

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00307515
Collaborator
OMRIX Biopharmaceuticals (Industry)
135
Enrollment
16
Locations
2
Arms
10
Duration (Months)
8.4
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fibrin Sealant 2 (FS2)
  • Device: Oxidized Regenerated Cellulose (Surgicel)
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

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:
  • CROSSEAL*
  • EVICEL*
  • tissue adhesive

    		•
    Active Comparator: 2

    Oxidized Regenerated Cellulose (Surgicel)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hemostatic success within 10 minutes. [Intraoperative]

    Secondary Outcome Measures

    1. Absence of bleeding at pre-defined time points within 10 minutes [Intraoperative]

    2. Incidence of treatment failures [Intraoperative]

    3. Incidence of potential bleeding-related complications [24 hr prior to discharge, Day 7-14]

    4. Adverse events [Intraoperative, 24 hr prior to discharge, Day 7-14]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Los Angeles Los Angeles California United States 90027
    2 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    3 Miami Research Associates Miami Florida United States 33173
    4 Medical College of Georgia Augusta Georgia United States 30912
    5 The Iowa Clinic Des Moines Iowa United States 50309
    6 St. Agnes Healthcare, Inc. Baltimore Maryland United States 21229
    7 Massachusetts General Hospital Boston Massachusetts United States 02114
    8 Cooper University Hospital Camden New Jersey United States 08103
    9 Mt. Sinai Hospital New York New York United States 10029
    10 GYN Oncology Associates Syracuse New York United States 13202
    11 Oregon Health and Science University Portland Oregon United States 97239
    12 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
    13 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15206
    14 Lankenau Hospital Wynnewood Pennsylvania United States 19096
    15 MD Anderson Cancer Center Houston Texas United States 77030
    16 The Methodist Hospital Houston Texas United States 77030

    Sponsors and Collaborators

    • Ethicon, Inc.
    • OMRIX Biopharmaceuticals

    Investigators

    • Study Director: James Hart, MD, Ethicon, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00307515
    Other Study ID Numbers:
    • 400-05-006
    First Posted:
    Mar 28, 2006
    Last Update Posted:
    Jan 9, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Blood Loss, Surgical
    Fibrin Tissue Adhesive

    Study Results

    No Results Posted as of Jan 9, 2009