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
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
