Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds

A Study to Assess the Safety and Efficacy of Fibrin Sealant (FS 4IU) for Wound Healing in Subjects With Burn Wounds Requiring Skin Grafting Procedures

The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • University of South Alabama Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
  • California
    • Orange, California, United States, 92868-3298
      • UCI Medical Center
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center; Shriners Hospitals for Children
    • San Diego, California, United States, 92103-8896
      • UCSD Medical Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Burn Center at Doctors Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Shriners Hospitals for Children
    • Dayton, Ohio, United States, 45409-2722
      • Wright State University, Miami Valley Hospital
  • Texas
    • Galveston, Texas, United States, 77550-2725
      • Shriners Hospitals for Children, Galveston
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Burn Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities
• Male or female age >= 6 and <= 65 years of age
• Total burn wounds measuring <= 40% TBSA to include a deep partial thickness/full thickness area requiring autologous split thickness sheet skin grafts
• The selected test area consisting of a contiguous, deep partial thickness/full thickness burn wound between 2% and 8% TBSA, which can be divided into two approximate halves or two bilateral wounds (each measuring between 1% and 4% TBSA)
• Females of child-bearing potential with a negative urine or serum pregnancy test on admission
• Able and willing to comply with the procedures required by the protocol

Exclusion Criteria:

• Conductive electrical burns and chemical burns
• Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
• Circumferential burns are excluded as a test area
• 4th or 5th degree burns
• Test area with infection as determined clinically by the Investigator prior to surgery
• Venous or arterial vascular disorder directly affecting a designated test area
• Known immune deficiency disorder, either congenital or acquired
• Chronically malnourished as determined clinically by the investigator prior to surgery (Investigators are responsible for determining subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: Medical history and physical appearance, the subject's body mass index, and any significant laboratory findings)
• Severe respiratory problems or concurrent head trauma at hospital admission
• Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
• Known or newly diagnosed diabetics requiring insulin
• Any other acute or chronic concurrent medical condition(s) that in the Investigator's opinion are a contraindication to skin grafting and study participation
• Known or suspected hypersensitivity to bovine protein
• Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Principal Investigator: David G. Greenhalgh, MD, University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA; Principal Investigator: Marianne Cinat, MD, University of California Irvine, Orange, CA; Principal Investigator: Arnold Luterman, MD, University of South Alabama Medical Center, Mobile, AL; Principal Investigator: Nicole Gibran, MD, University of Washington Burn Center, Seattle, WA; Principal Investigator: Glenn D. Warden, MD, Shriners Hospitals for Children, Cincinnati, OH; Principal Investigator: David Herndon, MD, Shriners Hospitals for Children, Galveston, TX; Principal Investigator: Richard L. Gamelli, MD, Loyola University Medical Center, Maywood, IL; Principal Investigator: Sidney F. Miller, MD, Wright State University, Miami Valley Hospital, Dayton, OH; Principal Investigator: Daniel Lozano, MD, University of California, San Diego; Principal Investigator: Philip E. Fidler, MD, Bridgeport Hospital, Bridgeport, CT; Principal Investigator: Kevin Foster, MD, Maricopa Medical Center, Phoenix, AZ; Principal Investigator: William L. Hickerson, MD, Joseph M. Still Burn Center at Doctors Hospital, August, GA

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Study Completion: January 1, 2004

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Estimate): October 20, 2006
• Last Update Submitted That Met QC Criteria: October 19, 2006
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Hemostatics; Coagulants; Fibrin Tissue Adhesive; Thrombin
• Other Study ID Numbers: 520001