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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2006

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®.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • Fibrin Sealant 2 (FS2)
  • Active Comparator: 2
    • Oxidized Regenerated Cellulose (Surgicel)

Clinical Trial Outcome Measures

Primary Measures

  • Hemostatic success within 10 minutes.
    • Time Frame: Intraoperative

Secondary Measures

  • Absence of bleeding at pre-defined time points within 10 minutes
    • Time Frame: Intraoperative
  • Incidence of treatment failures
    • Time Frame: Intraoperative
  • Incidence of potential bleeding-related complications
    • Time Frame: 24 hr prior to discharge, Day 7-14
  • Adverse events
    • Time Frame: Intraoperative, 24 hr prior to discharge, Day 7-14

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ethicon, Inc.
  • Collaborator
    • OMRIX Biopharmaceuticals
  • Provider of Information About this Clinical Study
    • Jonathan Batiller, MBA, Ethicon
  • Overall Official(s)
    • James Hart, MD, Study Director, Ethicon, Inc.

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