Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients

A Study To Evaluate the Safety and Efficacy of Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS 4IU VH S/D) to Adhere Tissues and Improve Wound Healing

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.

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.