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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 65
Updated:4/21/2017
Start Date:June 2004
End Date:February 2007

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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.
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