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MILLIKEN HEALTHCARE PRODUCTS, LLC
NuStat Clinical Summary
NuStat Flex is a proprietary blend of biocompatible silica and regenerated cellulose fibers
with inherent hemostatic properties.
The specialty fibers are combined to make a flexible dressing that conforms to the patient
to give direct contact with NuStat’s hemostatic fibers.
How NuStat Works
NuStat’s flexibilty allows the
dressing to contact the bleeding
area directly
Once in place NuStat Flex helps
control bleeding
NuStat’s proprietary cellulose
and silica fibers amplify the
clotting cascade
Upon removal, minimal to no
bleeding remains
Remove NuStat to continue care
Cauterization or sutures may be
required for high pressure
bleeding sources
NUSTAT
FLEX
NuStat Products
Product Code
Size
Ea/Bx
Ea/Cs
3000097319
4” x 8”
10
50
3000097333
12” x 12”
10
50
3000097317
3” x 48”
10
50
3000097320
4” x 48”
10
50
3000097331
6” x 60”
10
50
Clinical Trial Summary
Randomized Trial Comparing NuStat Flex™ Hemostatic Dressing to Thrombin/Epinephrine
During Burn Surgery.
SPECIFIC AIM:
To assess the safety and performance of NuStat Flex compared to thrombin/epinephrine and pressure in
excised burn wounds and donor sites.
TRIAL SITE:
University of South Alabama Medical Center Burn Center
DEMOGRAPHICS:
INCLUSION CRITERIA*:
N=20 16 Male/4 Female
Age: 43.5y +18.9
TBSA: 5.96% + 2.5
Extremities only
TBSA <10%
>19 Years Old
1st surgical procedure
HEMOSTATIC
DRESSINGS APPLIED
EXCISION
Area divided into 2 equal parts
Thrombin/
Epinephrine
NuStat
Flex
HEMOSTATIC
DRESSINGS REMOVED
NuStat
Flex
Thrombin/
Epinephrine
PRIMARY ENDPOINT
Total Blood Loss
Total Blood Loss in Excision Site:
Total Blood Loss in Donor Site:
NuStat Flex
Control
NuStat Flex
Control
25.38g (+22.77g)
40.32g (+78.07g)
p= 0.43
16.23g
17.08g
(+10.62g)
(+ 29.35g)
p=0.90
healthcare.milliken.com | [email protected] | 866.491.6556
Milliken Healthcare Products, LLC 920 Milliken Road Spartanburg, SC 29303 USA
NuStat FlexTM is a trademark of Beeken Biomedical.
*Full list of inclusions and exclusion criteria available upon request
NUSTATTRIALr01