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

NCT00161759 | Completed Phase 1

• 1 other identifier: 520001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 12

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

Interventions

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

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• th 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).

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (12)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

UCI Medical Center

Orange, California, 92868-3298, United States

Location

University of California Davis Medical Center; Shriners Hospitals for Children

Sacramento, California, 95817, United States

Location

UCSD Medical Center

San Diego, California, 92103-8896, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, 30909, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Shriners Hospitals for Children

Cincinnati, Ohio, 45229, United States

Location

Wright State University, Miami Valley Hospital

Dayton, Ohio, 45409-2722, United States

Location

Shriners Hospitals for Children, Galveston

Galveston, Texas, 77550-2725, United States

Location

University of Washington Burn Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Fibrin Tissue Adhesive; Thrombin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Blood Coagulation Factors; Biological Factors

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: March 1, 2002
• Study Completion: January 1, 2004
• Last Updated: October 20, 2006

Record last verified: 2006-10

Locations

US (12)