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

Use our guide to learn which trials are right for you!

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.
We found this trial at
17
sites
400
mi
from 43215
Allentown, PA
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
711
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
721
mi
from 43215
Lincoln, NE
Click here to add this to my saved trials
1130
mi
from 43215
Lubbock, TX
Click here to add this to my saved trials
394
mi
from 43215
Madison, WI
Click here to add this to my saved trials
284
mi
from 43215
Maywood, IL
Click here to add this to my saved trials
700
mi
from 43215
Mobile, AL
Click here to add this to my saved trials
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
353
mi
from 43215
Springfield, IL
Click here to add this to my saved trials