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 |
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.
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.
We found this trial at
17
sites
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