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

NCT ID: NCT00161759

Last Updated: 2006-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2004-01-31

Brief Summary

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

David G. Greenhalgh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California Davis Medical Center, Sacramento; Shriners Hospitals for Children, Sacramento, CA

Marianne Cinat, MD

Role: PRINCIPAL_INVESTIGATOR

University of California Irvine, Orange, CA

Arnold Luterman, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama Medical Center, Mobile, AL

Nicole Gibran, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington Burn Center, Seattle, WA

Glenn D. Warden, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children, Cincinnati, OH

David Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children, Galveston, TX

Richard L. Gamelli, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Medical Center, Maywood, IL

Sidney F. Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Wright State University, Miami Valley Hospital, Dayton, OH

Daniel Lozano, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Philip E. Fidler, MD

Role: PRINCIPAL_INVESTIGATOR

Bridgeport Hospital, Bridgeport, CT

Kevin Foster, MD

Role: PRINCIPAL_INVESTIGATOR

Maricopa Medical Center, Phoenix, AZ

William L. Hickerson, MD

Role: PRINCIPAL_INVESTIGATOR

Joseph M. Still Burn Center at Doctors Hospital, August, GA

Locations

University of South Alabama Medical Center

Mobile, Alabama, United States

Maricopa Medical Center

Phoenix, Arizona, United States

UCI Medical Center

Orange, California, United States

University of California Davis Medical Center; Shriners Hospitals for Children

Sacramento, California, United States

UCSD Medical Center

San Diego, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

Shriners Hospitals for Children

Cincinnati, Ohio, United States

Wright State University, Miami Valley Hospital

Dayton, Ohio, United States

Shriners Hospitals for Children, Galveston

Galveston, Texas, United States

University of Washington Burn Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

520001

Identifier Type: -

Identifier Source: org_study_id