Skip to main content
OpenTrials
Completed

NCT Number: NCT00307515

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital of Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrin Sealant 2 (FS2)

Drug

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

Oxidized Regenerated Cellulose (Surgicel)

Device

Commercially available Surgicel used within label.

Other names: Surgicel*

Primary outcomes

  1. Hemostatic success within 10 minutes.

    Time frame: Intraoperative

Secondary outcomes

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

    Time frame: Intraoperative

  2. Incidence of treatment failures

    Time frame: Intraoperative

  3. Incidence of potential bleeding-related complications

    Time frame: 24 hr prior to discharge, Day 7-14

  4. Adverse events

    Time frame: Intraoperative, 24 hr prior to discharge, Day 7-14

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • OMRIX Biopharmaceuticals

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 28, 2006
Registry last updated
Jan 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.