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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161759
First received: September 8, 2005
Last updated: October 19, 2006
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Burns
Drug: Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 40
Study Start Date: March 2002
Estimated Study Completion Date: January 2004
  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161759

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

No publications provided

ClinicalTrials.gov Identifier: NCT00161759     History of Changes
Other Study ID Numbers: 520001
Study First Received: September 8, 2005
Last Updated: October 19, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014