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
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Lead
Baxter Healthcare Corporation
Age
0–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
