The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.

Condition	Intervention	Phase
Deep partial or full thickness wounds	Drug: Fibrin Sealant, Tisseel 4IU/ml VH SD	Phase III

Further Study Details: 

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects or their legal representatives, who have read, understood and signed a written informed consent.
• Subjects of either sex.
• Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
• Subjects who are <= 65 years of age including pediatric subjects of all ages.
• Subjects with total burn wounds measuring <= 40% TBSA.
• Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
• Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000” – 16/1000”
• Subjects who are able, and willing to comply with the procedures required by the protocol.

Exclusion Criteria:

• Subjects with electrical burns.
• Subjects with chemical burns
• Digits and genitalia are excluded as test sites.
• Subjects with infection at test area/test sites.
• Subjects with test sites previously randomized and treated in this study.
• Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
• Subjects with pre-existing hemolytic anemia
• Subjects with diabetes mellitus.
• Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
• Subjects judged to be chronically malnourished.
• Subjects that are judged to have significant pulmonary compromise.
• Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids).
• Subjects with known or suspected hypersensitivity to bovine proteins.
• Subjects participating in another clinical trial that is evaluating an unapproved drug or device.

Please refer to this study by ClinicalTrials.gov identifier  NCT00157131

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35292,  United States; Recruiting
      University of South Alabama, Mobile,  Alabama,  36617,  United States; Recruiting
Arizona
      Maricopa Medical Center, Phoenix,  Arizona,  85008,  United States; Recruiting
California
      Shriners Hospitals for Children, Northern Calif., Sacramento,  California,  95817,  United States; Recruiting
      UCSD Medical Center, San Diego,  California,  92103-8896,  United States; Terminated
      UCI Medical Center, Orange,  California,  92868-3298,  United States; Not yet recruiting
Illinois
      SIU School of Medicine, Springfield,  Illinois,  62702-9653,  United States; Recruiting
      Director of Burn & Shock Trauma Institute, Maywood,  Illinois,  60153,  United States; Not yet recruiting
Texas
      Texas Tech University Health Sciences Center, Lubbock,  Texas,  79430-8183,  United States; Recruiting
Washington
      University of Washington Burn Center, Seattle,  Washington,  98104,  United States; Recruiting

Study chairs or principal investigators

David Greenhalgh, MD,  Principal Investigator,  Shriners Hospitals for Children, Northern Calif.   

Study ID Numbers:  550201
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157131
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13