StatSeal
®
Don’t Just Cover It…Seal It.
StatSeal
StatSeal
DISC
®
For Venous Access Sites
®
StatSeal
For Wounds and Procedures
For Large-Bore Catheters and
Arterial Access Sites
Seal the Site. STAT.
TM
With the Family of Products That Stop Bleeding
and Help Protect Wounds and Procedural Sites
®
What is StatSeal?
StatSeal medical devices, in powder or disc form, are made of a hydrophilic polymer and
potassium ferrate. When placed on an external bleeding wound or procedural site, in combination with manual pressure, StatSeal forms a seal that stops bleeding and helps protect
the site from contamination.
Seal formation is independent of the clotting cascade.
How Do StatSeal Products Work?
StatSeal quickly forms a seal to stop the flow of blood and exudates, and protect the site
from contamination.
The mechanism of action is a simultaneous two-step action:
1. The polymer rapidly dehydrates the blood, stacking up the solid components.
2. The potassium ferrate agglomerates the blood solids creating a seal or physical barrier.
Beneath the seal, the blood clots naturally.
In-Vitro studies* show that on the distal side of the seal, pH is low (~2) while on the proximal
side of the seal, pH is neutral.
StatSeal (unactivated powder)
“The Seal”
Illustration of seal formation
Scanning Electron Microscopy
(SEM) photo of seal
StatSeal works for patients of any age.
* Study report on file at Biolife LLC
StatSeal
Patented Technology
That Stops External Bleeding
From Wounds and Procedures
What Is It?
StatSeal Powder quickly forms a seal to stop external bleeding and oozing from wounds and procedures.
The powder’s ingredients are a hydrophilic polymer and potassium ferrate.
StatSeal Powder is effective for:
•
•
•
•
•
•
•
•
Vascular access site bleeding and oozing
Skin tears
Lacerations
Avulsions
Biopsies and excisions
Wound debridement
Other non-suturable wounds
Bleeding from sutures
The Benefits of StatSeal Powder
• Seal forms instantly upon contact with blood or exudate, strengthening
with pressure and time
• Does not rely on the body’s clotting cascade to create a seal
• Works for patients of any age
Improves Outcomes
• Increases patient comfort and satisfaction
• Hypo-allergenic, not biologically derived
• Fewer dressing changes and occurrences of rebleeds
SPFI03
Controls Bleeding and Oozing
Efficient and Cost-effective
• Fast hemostasis and fewer dressing changes saves valuable nursing time
• Less expensive than other hemostats
StatSeal
®
Instructions for Use - Skin Tears, Avulsions and
Other Non-Suturable wounds
Application includes 1 bottle, 1 Powder Containment Device (PCD)
and 1 product description label.
Use of the PCD is optional. The PCD and foam insert can help contain powder when applied to
vertical surfaces.
1. Clean wound and ensure blood or exudate is present.
2. Tap bottom of bottle to pour powder directly onto blood or bloody exudate. Cover bleeding
area completely. Occasionally upon application, a temporary warming or stinging sensation is felt.
3. Apply pressure for 30 seconds to 2 minutes to form the protective seal.
not recommended). If bleeding continues, repeat application.
(Holding pressure with gauze is
4. Dress the wound with non-adherent dressing. The protective seal is safe to leave in place until it falls off
naturally.
Instructions for Use – Vascular Access Sites
Before applying powder, secure catheter near access site. Catheter movement after powder is applied can disrupt
newly-formed seal.
1. Place PCD around site, pour powder into PCD. Place foam center in PCD to cover powder.
2. Hold continuous pressure for 2 minutes to form seal; increase hold times as clinically necessary.
3. If bleeding continues, reapply more powder and hold manual pressure until bleeding stops.
4. Cover with transparent dressing following normal protocol; press and form transparent dressing around
powder to help contain powder around access site.
Site should remain dry and intact until next scheduled dressing change.
You may feel a slight warming from the powder as it forms the seal.
To remove StatSeal: If StatSeal Powder must be removed, as determined by a healthcare professional, brush away
loose powder then wet the seal with sterile water/saline until seal starts loosening from the wound. Gently scrape off
loosened seal with gloved finger. Repeat as needed.
1-800-722-7559
www.statseal.com
StatSeal advanced Powder and Disc
®
What Is It?
Patented Technology
to Seal Access Sites Following
Sheath and Catheter Removal
StatSeal® ADVANCED is a manual pressure adjunct that controls external bleeding from
large-bore venous catheters, arterial access procedures, and other diagnostic or interventional
procedures. Available in both powder and disc (compressed powder) form, the ingredients are a
hydrophilic polymer and potassium ferrate.
Disc/Powder + Pressure = Seal
As an adjunct to manual pressure, StatSeal® ADVANCED forms a physical seal through agglomeration of
blood solids and proteins along with simultaneous rapid dehydration of the blood.
The Benefits of StatSeal® ADVANCED
Reduces hold times
• Does not rely on the body’s clotting cascade
• Seal forms instantly and strengthens with pressure and time
• The seal stays with the patient
Improves outcomes
• Increases patient comfort and satisfaction
• Allows for re-access of the site
• Hypo-allergenic, non-irritant
Improves facility throughput
• Efficient and Cost-effective
• Less expensive than pads, patches and closure devices
• Versatile – useful in the control of any external bleeding
• Saves valuable staff time
StatSeal® ADVANCED achieved hemostasis in less than two minutes for venous access and four minutes
for arterial procedures based on results from a randomized controlled clinical study. StatSeal®
effectively reduced time to hemostasis with minimal associated complications (hematoma,
rebleeds). StatSeal® is superior to the control (D-Stat®) in reducing time to hemostasis.*
*Michael D. Kuo, MD et al. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008.
SPFI02r1
StatSeal
®
Instructions for Use - StatSeal® ADVANCED Powder
Application includes 1 bottle, 1 Powder Containment Device (PCD) and 1 product
description label.
StatSeal
®
HPS01r3
Leave scab in
place as directed
TOPICAL HEMOSTATIC POWDER
1.
2.
3.
4.
5.
6.
1. Clean and dry the area around the site.
Withdraw sheath leaving at least 3 to 4 centimeters (2-3 cms for fistula/grafts) under the skin. Remove PCD from package,
peel paper backing and center (PCD) around sheath.
2. Pour powder into PCD* - lift sheath gently to ensure powder gets under sheath, then create a pile of powder around the sheath
and completely fill the PCD.
3. Place PCD center (foam insert) over powder. Pull sheath slowly while applying pressure over the arteriotomy and the insertion site.
4. StatSeal® Advanced is a manual pressure adjunct. For initial uses, start at current manual pressure hold times then gradually adjust
down toward 5 to 10 minutes of continuous pressure. Extend hold times as clinically necessary.
5. Release pressure slowly; Roll fingers off PCD**.
6. Place transparent dressing per protocol; Apply product description label on top of dressing to identify powder. Follow your
normal ambulation protocol.
* Fill PCD completely; don’t overfill; the bottle contains excess powder in case of a rebleed.
** If bleeding continues, reapply more powder (if necessary) with manual compression until bleeding has stopped. You may feel a
slight warming from the powder as it forms the seal.
To remove Statseal® Advanced: If Statseal® Advanced Powder must be removed, as determined by a healthcare professional, brush
away loose powder then wet the seal with sterile water/saline until seal starts loosening from the wound. Gently scrape off loosened
seal with gloved finger, cotton swab or tongue depressor. Repeat as needed.
Instructions For Use: StatSeal® ADVANCED Disc
Application includes 1 StatSeal® Advanced Disc.
1. Open sterile packaging and remove disc.
2. Place disc over the sheath at access site, align disc slit with sheath. Pull sheath slowly while applying pressure
directly over the arteriotomy and puncture site.
3. Hold continuous semi-occlusive pressure over disc and arteriotomy site for >=5 minutes (Extend hold times
as necessary for larger sheaths or anticoagulated patients).
4. Release pressure slowly to check for hemostasis. Apply additional pressure as necessary.
5. Place transparent dressing per protocol. Apply product description label.
6. Leave disc in place for 24 hours or as directed by clinician.
1-800-722-7559
www.statseal.com
StatSeal Disc
®
Seal the Site. STAT.
The Challenge: How to Protect an Access Site
• “Soiled, wet or loose dressings must be changed” since they provide an optimum environment for bacterial growth according to CDC Guidelines for the Prevention of
Intravascular Catheter-Related Infections, 2011.
• Soiled gauze or CHG-impregnated sponges have been clinically shown to result in frequent dressing changes.1
• Dressing changes require valuable nursing time, added material cost and
expose the site.
Access site with soiled CHG sponge
• Dressing disruption is a major risk factor for catheter-related infections.*
The Solution: StatSeal® Disc
The patented technology of StatSeal ® (BioSeal) Powder, now in an easy-to-use disc!
StatSeal® Disc is a topical disc, made of compressed powder (hydrophilic polymer and potassium ferrate) that forms a seal
over an access site to keep it dry and intact. StatSeal® Disc is available in various sizes to fit securely around different sizes
of catheters (1.9-14 Fr).
Benefits of StatSeal® Disc:
Creates a seal that prevents bleeding and oozing
• Seal forms instantly, strengthening with manual pressure and time
• Does not rely on the body’s clotting cascade
• Works with any protein-filled fluid
Helps minimize dressing changes
• Seals sites from insertion to 7 days, virtually eliminating 24 or 48-hour
dressing changes
• Helps minimize unplanned dressing changes due to bleeding and oozing
• Helps follow CDC guidelines by keeping sites dry and intact
Helps improve outcomes for patients and staff
• Less exposure of site - Improves delivery of atraumatic care
• Saves nursing time and costs
“The StatSeal® disc is a game changer! For PICC and central line insertions, the disc keeps
sites dry and intact. It is truly the future of hemostasis and vascular access site care.”
Louis Guzzi, MD
– Critical Care Medicine, Florida Hospital
1Timsit, et al, JAMA, March 25, 2009, “Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults”.
*”Timsit JF, Bouadma L, Ruckly S, et al, Crit Care Med. 2012;40:1707-1714 ”Dressing Disruption Is a Major Risk Factor for Catheter-Related Infection,”
SPFI01r4
SDTE01r2
StatSeal
®
The Difference is the Seal
DISC
How does StatSeal® Disc Work?
StatSeal® quickly forms a seal to stop the flow of blood and exudates.
The mechanism of action is a simultaneous two-step action:
1. The polymer rapidly dehydrates the blood, stacking up the solid
blood components.
2. The potassium ferrate agglomerates the blood solids creating a
physical barrier.
Beneath the seal, the blood clots naturally.
Instructions For Use:
Application includes 1 StatSeal® Disc.
StatSeal® Disc is intended for use under the care of a health care professional for the temporary external control
of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
1. Prepare the skin around insertion site according to facility protocol.
2. Open sterile packaging and remove disc.
3. Place the disc by sliding it down the catheter until it touches skin at the catheter site.
The brown side should be towards the patient’s skin and the slit perpendicular to the
catheter. The edges of the slit should approximate one another to the extent possible.
The foam side is facing up.
Tip: Don’t stretch the disc apart too much upon application.
4. Apply a continuous hold on top of the foam for at least 2 minutes to form the
seal; increase the hold time as clinically necessary.
5. Secure the catheter per protocol.
6. Cover with transparent dressing following facility protocol.
7. Remove disc with next dressing change and resume regular dressing protocol.
Site should remain dry and intact until next scheduled dressing change.
Close up of underside
of foam showing
compressed powder
With StatSeal® Disc, it’s ONE and DONE!
1-800-722-7559
www.statseal.com
StatSeal in Clinical and Laboratory Studies
ACHIEVES RAPID HEMOSTASIS, STOPS OOZING
In a peer-reviewed clinical trial published in the Journal of Vascular and Interventional Radiology (January 2008)
comparing the efficacy of two compression adjuncts in 176 percutaneous vascular access procedures, StatSeal
was twice as fast in achieving hemostasis as the control with no differences in infections or adverse events.
Results: StatSeal reduced mean time to hemostasis to under 4 minutes for
arterial procedures.*
Mean Time to Hemostasis (min.)
Control (D-Stat)
StatSeal
Procedure Type
Arterial - Therapeutic
3.56
9.99
Arteriovenous Dialysis Access
3.41
7.26
*Hold times may vary due to anticoagulation levels, sheath sizes or clinical techniques.
Michael D. Kuo, MD, et al, Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous,
and Arteriovenous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008.
PROVIDES BETTER PATIENT OUTCOMES
A peer-reviewed clinical trial published in the Journal of the Association for
Vascular Access** showed that when used for all PICC line insertions (418) and
occasional bleeding during dressing changes at Florida Hospital, StatSeal:
• Showed a 40% decrease in Catheter-Related Bloodstream Infections
(CRBSIs) during and post-trial
• Eliminated the 48-hour dressing change; initial dressing change
performed at 7 days
• Achieved fast hemostasis, even for patients with clotting difficulties
(≤ 2 min. in 96% of applications)
• Resulted in no reported complications.
** Lauren Blough, RN, BS, CRNI, Kathy Hinson, BS, RN, MN, MPH, MBA, John Hen, PhD, “The Science of a “Seal” for PICC Line Management: BIOSEAL CVC
Powder As An Alternative Hemostatic Agent That Keeps Sites Dry And Intact,” Journal of the Association for Vascular Access, Summer 2010, 15:2, 66-73.
In a study of Mohs Micrographic Surgery, StatSeal showed greater efficacy
and more rapid onset of action in second intention healing compared with
the control compressed foam sponge (at week 12). StatSeal reduced erythema
and produced fewer incidents of scarring.
Leon Kircik, MD and James Q. DelRosso, DO. Journal of Drugs in Dermatology (JDD), February 2010, Vol. 9,
Issue 2: 137-140,
StatSeal Powder applied to a Mohs site
SPFI04
StatSeal® Product Ordering Information
StatSeal
®
DISC
StatSeal® Disc - Extra Small to Large size: For temporary external control of bleeding from percutaneous catheters
StatSeal® ADVANCED Disc - For temporary external control of bleeding from sheath and catheter removals
Underside of foam
showing compressed
powder disc
Extra Small
~1.9-4 FR
Small
Medium
~6-9 FR
~10-14 FR
Carton
DT613
DS614
DM615
DL616
DA618
Case
DT623
DS624
DM625
DL626
DA628
Carton
6
6
6
6
6
Case
24
24
24
24
24
Size
~4-6 FR
Large
Advanced
Item Number:
Number of Applications:
StatSeal
®
StatSeal® Powder
Stops external bleeding from wounds and procedures
Manufacturer Item Number
Description
Number of Applications
LP606
Carton
6
LP636
Case
24
StatSeal
®
StatSeal® ADVANCED Powder
Seals arterial access sites
SPFI05r3
Manufacturer Item Number
Description
Number of Applications
LP607
Carton
6
LP637
Case
24
StatSeal
®
Seal the Site. STAT.
TM
8163 25th Court East, Sarasota, FL. 34243
1-800-722-7559 • www.statseal.com
SSPF01