Representative test samples from the D-Stat Silver product
family (Dry, Wrap and Thrombix Silver) demonstrated an
antimicrobial effect in the following laboratory testing:
AATCC Test Method 100-2004 against Candida albicans,
VRE, Escherichia coli, Klebsiella pneumoniae,
Pseudomonas aeruginosa, MRSA, and MRSE.
Zone of Inhibition laboratory testing demonstrated the
following:
Culture Name
Candida albicans
Average of
Zone of Inhibition
Results
(Reported in mm)
40*
Do not place the D-Stat Dry Silver into blood vessels.
Extensive intravascular clotting and even death may result.
The D-Stat Dry Silver is supplied sterile for single use only.
Do not re-sterilize.
Do not use D-Stat Dry Silver as a replacement for
absorbable hemostats. This product contains nonabsorbable materials and is not intended to be left in the
body.
PRECAUTIONS
Do not use the D-Stat Dry Silver if the packaging has been
damaged.
The safety and effectiveness of the D-Stat Dry Silver have
not been established in children and pregnant women who
have undergone a diagnostic endovascular procedure
involving a 4-6 Fr. sheath.
Enterococcus faecalis (VRE)
29
Escherichia coli
29
Klebsiella pneumoniae
33
Pseudomonas aeruginosa
29
Staphylococcus aureus (MRSA)
33
Staphylococcus epidermidis
(MRSE)
Enterococcus faecalis
38
Do not touch the D-Stat Dry Silver lyophilized pad with wet
gloves or expose the pad to liquid. Absorption of the liquid
and destruction of the pad will result.
27
Do not leave the D-Stat Dry Silver pad or adhesive bandage
applied for more than 24 hours. Skin irritation may result.
Staphylococcus aureus
34
Staphylococcus epidermidis
38
*Product sample reconstituted with 1mL of sterile water
D-Stat Dry Silver has not been clinically tested for its ability
to reduce local infection, catheter-related bloodstream
infections (CRBSI) and skin colonization of microorganisms
commonly related to CRBSI. No clinical trials have been
performed with D-Stat Silver products. These products have
not been shown to be more clinically effective than a
dressing not containing an antimicrobial agent.
Sodium carboxymethylcellulose, also known as cellulose
gum or CMC, serves as the matrix for the lyophilized pad
and as a suspension agent for the thrombin.
The D-Stat Dry Silver should not be used in the presence of
infection. It should be used with caution in contaminated
areas of the body.
When removing the D-Stat Dry Silver lyophilized pad and
the adhesive bandage, do not disrupt the clot by physical
manipulation. If the pad adheres to the puncture site, irrigate
the pad with non-heparinized saline and carefully remove it.
ADVERSE EVENTS
A recognized rare potential reaction associated with the use
of bovine derived thrombin is the development of inhibitory
antibodies, which interferes with hemostasis.
RANDOMIZED MULTI-CENTER INVESTIGATION
Results are presented below for the randomized trial
performed to evaluate the safety and effectiveness of the DStat Dry hemostatic bandage (no silver) in patients
undergoing diagnostic endovascular catheterization
procedures that utilized a 4F, 5F or 6F introducer sheath.
Hemostasis is achieved by the physiological coagulationinducing properties of the lyophilized pad combined with
manual compression.
This data is applicable to the D-Stat Dry Silver as nonclinical bench and in vivo animal testing has demonstrated
similar hemostatic performance profiles for the D-Stat Dry
D-Stat Dry Silver Hemostatic Bandage
The D-Stat Dry Silver and D-Stat Dry Clear Silver have been and D-Stat Dry Silver products.
Topical Hemostat
sterilized with irradiation.
The purpose of this study was to evaluate the safety and
Model 3000
effectiveness of the D-Stat Dry hemostatic bandage in
patients undergoing diagnostic endovascular catheterization
D-Stat® Dry Clear Silver Hemostatic
procedures that utilized a 4F, 5F or 6F introducer sheath.
INDICATIONS
Bandage Topical Hemostat
This prospective, multi-center (5 centers), randomized, nonThe D-Stat Dry Silver is applied topically as an adjunct to
significant risk investigation evaluated a total of three
manual compression and is indicated for the control of
Model 3005
hundred seventy-six (376) subjects randomized at a 1:1
surface bleeding from vascular access sites and
Instructions For Use
ratio to treatment with either D-Stat Dry with manual
percutaneous catheters or tubes and reducing the time-tocompression (the Investigation Group) or standard manual
hemostasis in patients undergoing diagnostic endovascular
USA CAUTION
compression alone (the Control Group). Of the 376
procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry
Federal (USA) law restricts this device to sale by or on the
randomized patients, 187 (49.73%) were randomized to the
Silver contains silver chloride to prevent microorganisms
order of a physician.
commonly encountered in the clinical setting from colonizing Investigation Group and 189 (50.27%) were randomized to
DEVICE DESCRIPTION
the Control Group.
on the pad.
Each D-Stat Dry Silver hemostatic bandage (D-Stat Dry
A total of 3 major adverse events (1 D-Stat Dry, 2 Standard
CONTRAINDICATIONS
Silver) consists of the following components:
Compression) were reported during the randomized
The D-Stat Dry Silver is contraindicated in persons with

Lyophilized pad consisting of thrombin, silver
investigation. All of these major adverse events were
known sensitivity to bovine-derived materials.
chloride, sodium carboxymethylcellulose and calcium
determined to be unrelated to post procedure methods.
WARNINGS
chloride in a nonwoven gauze
Table 1 presents the distribution of major adverse events for

Adhesive bandage
the treatment groups. No statistical differences were
The use of topical bovine thrombin preparations has
observed between groups.
occasionally been associated with abnormalities in
Thrombin is a protein substance produced through a
hemostasis ranging from asymptomatic alterations in
Table 1: Distribution of Major Adverse Events
conversion reaction in which prothrombin of bovine origin is
laboratory determinations, such as prothrombin time (PT)
Treatment Group
activated by tissue thromboplastin of bovine origin in the
and partial thromboplastin time (PTT), to severe bleeding
Investigation
Control
presence of calcium chloride. Thrombin contains no
or thrombosis which rarely have been fatal. These
Group
Group
(n=187)
(n=189)
p value
preservative and has been chromatographically purified.
hemostatic effects appear to be related to the formation
Thrombin requires no intermediate physiological agent for its
of antibodies against bovine thrombin and/or factor V
%
N
%
n
reaction. It converts fibrinogen directly to fibrin. This product
which in some cases may cross react with human factor
Pseudoaneurysm
0.0
0
0.5
1
1.000*
contains not less than 200 units of bovine derived thrombin.
V, potentially resulting in factor V deficiency. Repeated
clinical applications of topical bovine thrombin increase
This product contains no more than 500 mcg of silver
Retroperitoneal bleed
0.5
1
0.0
0
0.497*
the likelihood that antibodies against thrombin and/or
content from the silver chloride form. In the presence of
factor V may be formed. Consultation with an expert in
Other (rhythm disturbance)
0.0
0
0.5
1
1.000*
fluids (i.e., blood and wound fluids), ionic silver is released
coagulation disorders is recommended if a patient
from the silver chloride to prevent microorganisms
All adverse events
0.5
1
1.1
2
0.0001**
exhibits
abnormal
coagulation
laboratory
values,
commonly encountered in the clinical setting from colonizing
abnormal bleeding, or abnormal thrombosis following the
* Calculated using Fisher’s Exact Test.
on the pad. Ionic silver, an atom of silver that is missing one
use of topical thrombin. Any interventions should consider ** Calculated using Blackwelder’s Test of Non-inferiority.
electron, provides the antimicrobial property by altering the
the
immunologic
basis
of
this
condition.
Patients
with
This clinical investigation yielded a low major adverse event
protein structure and preventing bacterial cells from carrying
antibodies to bovine thrombin preparations should not be
out normal functions.
rate of 0.5% (1/187) in the Investigation Group and 1.1%
re-exposed to these products.
(2/189) in the Control Group, and the Investigation Group
®
was demonstrated to be statistically non-inferior to the
Control Group. In addition, no unanticipated adverse device
effects were observed. This trial demonstrated that use of DStat Dry as an adjunct to standard manual compression in
the intended study population was safe.
A total of three minor adverse events (1 D-Stat Dry, 2
Standard Compression) were reported during this
investigation as described in Table 2.
Carefully inspect the D-Stat Dry Silver packaging (foil pouch
and foil sealed inner tray) and components for damage prior
to use.
3.
Table 2: Distribution of Minor Adverse Events
Two Hand Application Procedure (recommended)
1. Using sterile technique, open the foil pouch and
transfer the tray into the sterile field.
2.
Peel back the lid of the tray completely. On a sterile
drape, turn the tray upside down and tap on the
bottom to detach the pad from the tray.
4.
Minor Adverse Events
Non-treated
pseudoaneurysm or
non-treated
arteriovenous (AV)
fistula documented by
ultrasound
Access site
hematoma >6cm
Investigation
Group
n = 187
%
n
Control
Group
n = 189
%
n
Combined
Groups
n = 376
%
n
0.0
0.0
0.5
1
0.3
1
0.5
1
0.5
1
0.5
2
The primary effectiveness endpoint of this clinical trial was
to demonstrate a reduced time-to-hemostasis with D-Stat
Dry as compared with standard manual compression in
patients with a bleeding femoral arterial access site
subsequent to a diagnostic endovascular catheterization
procedure.
Time-to-hemostasis was defined as: the time from the
removal of the femoral artery sheath and initiation of
compression at the femoral arterial access site to the time
hemostasis is first observed at the femoral arterial access
site, so long as hemostasis was maintained for at least 5
consecutive minutes following the first observation of
hemostasis.
Conduct of this trial successfully demonstrated the
effectiveness of D-Stat Dry in the overall reduction in TimeTo-Hemostasis as evidenced in the mean TTH observed for
the Investigation Group of 7.8 minutes compared to the
observed mean TTH of 13.0 minutes for the Control Group.
As previously stated, this difference is significant with a pvalue of 0.001. Further, a 50% reduction in the median
Time-To-Hemostasis (6 minutes) was observed in the
Investigation Group when compared to the Control Group
(12 minutes).
3.
4.
5.
6.
7.
Table 3: Time-To-Hemostasis (TTH) Results
n
Median TTH (mins)
Mean TTH (mins)*
± Standard Deviation
Range (min/max)
p-value*
*Wilcoxon’s Rank-sum Test
8.
Note that the safety and effectiveness of D-Stat Dry has not
been established in the following patient populations:
9.
Using sterile technique, open the adhesive bandage
packaging and transfer the bandage into the sterile
field.
With one hand, apply occlusive pressure proximal to
the arterial puncture site. Slowly ease off occlusive
pressure to firm pressure, and remove the sheath with
the other hand.
Allow a ”dime-sized” amount of blood to form on the
skin puncture site. Immediately return to occlusive
pressure.
With the other hand, place the pad directly over the
7.
skin puncture site and apply firm, non-occlusive
pressure. Maintain occlusive pressure proximal to the
arterial puncture site.
Slowly, over a 1-3 minute timeframe, release occlusive
pressure while maintaining firm, non-occlusive
pressure for the recommended hold time.
 For diagnostic patients utilizing 4-6F sheaths, hold
pressure for a minimum of 6 minutes or until
8.
hemostasis is achieved.
 For anticoagulated patients, hypertensive patients
9.
or patients on IIb/IIIa’s, Lovenox or Plavix, follow
institutional guidelines for time of sheath pull and
then apply pressure for a minimum of 10 minutes or
until hemostasis is achieved.
 For Angiomax patients without renal impairment,
wait 1 hour or longer to pull the sheath and then
hold for a minimum of 10 minutes or until
hemostasis is achieved.
 For dialysis patients, follow the institutional ACT
protocol and then hold for a minimum of 10 minutes
or until hemostasis is achieved.
While leaving the D-Stat Dry Silver pad in place,
slowly release pressure and confirm hemostasis. If
hemostasis has not been achieved, reapply firm, nonocclusive pressure until hemostasis is confirmed.
Note: Removing the pad may disrupt the newly
formed clot.
Once hemostasis has been confirmed, apply the
adhesive bandage directly on the skin over the D-Stat
Dry Silver access site.
If desired, the adhesive bandage may be left in place
for up to 24 hours.
 Patients undergoing an interventional procedure via the
same sheath through which the study procedure was
performed
 Patients who have a posterior wall stick during access of 10.
the femoral artery
Precaution: Do not leave the adhesive bandage
 Patients who have multiple (>1) tissue tracts made during
applied for more than 24 hours. Skin irritation may
access of the femoral artery
result.
 Patients who have been heavily anticoagulated (ACT
>400 sec) at the end of the catheterization procedure
Precaution: When removing the D-Stat Dry Silver
 Patients receiving Angiomax or Refludan
lyophilized pad and the adhesive bandage, do not
 Patients who have arterial introducer sheaths of <4F and
disrupt the clot by physical manipulation. If the pad
>6F
adheres to the puncture site, irrigate the pad with non Patients who have a large hematoma (>6cm in diameter)
heparinized saline and carefully remove it.
present prior to topical sealing
Note: Table 4 below offers minimum guidelines to
 Patients with “uncontrolled” blood pressure (systolic
assist in determination of ambulation times for
>180mm Hg / diastolic >110mm Hg) at end of
diagnostic endovascular patients; however, these
catheterization procedure
guidelines should not supercede clinical judgment
 Patients with a known bleeding disorder, including
based on the medical condition of the individual
thrombocytopenia (<100,000 platelet count),
patient.
thrombasthenia, hemophilia, von Willebrand’s disease or
Table 4: Ambulation Guidelines
anemia (Hgb <10g/dL; Hct <30)
Medication
Sheath
 Women who are known or suspected to be pregnant or
Ambulation Guidelines
Status
Size
lactating
Not Anti1.5 to 2.5 hours bed rest
 Patients receiving coumadin/warfarin with a documented
4, 5, 6 Fr.
coagulated
post sheath removal
baseline INR >2.0
Anti2.0 to 3.0 hours bed rest
 Patients receiving thrombolytic therapy (e.g., strepto4, 5, 6 Fr.
coagulated
post sheath removal
kinase, urokinase, t-PA) within the last 24 hours
 Patients with known allergies to bovine-derived products
One Hand Application Procedure
CLINICAL PROCEDURE
1.
Using sterile technique, open the foil pouch and
The D-Stat Dry Silver should be used by physicians trained
transfer the tray into the sterile field.
on the procedures for which the device is intended. The
2.
Peel back the lid of the tray completely. On a sterile
techniques and procedures described do not represent ALL
drape, turn the tray upside down and tap on the
medically acceptable protocols, nor are they intended as a
bottom to detach the pad from the tray.
substitute for the physician's experience and judgment in
Precaution: Do not touch the D-Stat Dry Silver
treating any specific patient. All available data, including the
lyophilized pad with wet gloves or expose the D-Stat
patient’s signs and symptoms and other diagnostic test
Dry Silver pad to liquid. Absorption of the liquid and
results, should be considered before determining a specific
destruction of the pad will result.
treatment plan.
©2011 Vascular Solutions, Inc.
2
6.
Precaution: Do not touch the D-Stat Dry Silver
lyophilized pad with wet gloves or expose the D-Stat
Dry Silver pad to liquid. Absorption of the liquid and
destruction of the pad will result.
A summary of this data is presented in Table 3 below.
Treatment Group
Investigation
Control
Group
Group
187
189
6.0
12.0
7.8
13.0
3.0
6.4
6, 22
6, 31
0.001
5.
Using sterile technique, open the adhesive bandage
packaging and transfer the bandage into the sterile
field.
Place the pad directly over the puncture site and apply
firm, non-occlusive pressure.
Remove the sheath according to institutional protocol,
and allow a ”dime-sized” amount of blood to come into
contact with the pad.
Maintain firm, non-occlusive pressure over the
puncture site for the recommended time.
 For diagnostic patients utilizing 4-6F sheaths, hold
pressure for a minimum of 6 minutes or until
hemostasis is achieved.
 For anticoagulated patients, hypertensive patients
or patients on IIb/IIIa’s, Lovenox or Plavix, follow
institutional guidelines for time of sheath pull and
then apply pressure for a minimum of 10 minutes or
until hemostasis is achieved.
 For Angiomax patients without renal impairment,
wait 1 hour or longer to pull the sheath and then
hold for a minimum of 10 minutes or until
hemostasis is achieved.
 For dialysis patients, follow the institutional ACT
protocol and then hold for a minimum of 10 minutes
or until hemostasis is achieved.
While leaving the pad in place, slowly release
pressure and observe the puncture site to determine if
hemostasis has been achieved. If hemostasis has not
been achieved, reapply firm, non-occlusive pressure
over the puncture site until hemostasis is confirmed.
Note: Removing the pad may disrupt the newly
formed clot.
Once hemostasis has been confirmed, apply the
adhesive bandage over the pad.
If desired, the adhesive bandage may be left in place
for up to 24 hours.
Precaution: Do not leave the adhesive bandage
applied for more than 24 hours. Skin irritation may
result.
Precaution: When removing the D-Stat Dry Silver
lyophilized pad and the adhesive bandage, do not
disrupt the clot by physical manipulation. If the pad
adheres to the puncture site, irrigate the pad with nonheparinized saline and carefully remove it.
Note: Table 5 below offers minimum guidelines to
assist in determination of ambulation times for
diagnostic endovascular patients; however, these
guidelines should not supercede clinical judgment
based on the medical condition of the individual
patient.
Table 5: Ambulation Guidelines
Medication
Status
Not Anticoagulated
Anticoagulated
Sheath
Size
Ambulation Guidelines
4, 5, 6 Fr.
1.5 to 2.5 hours bed rest
post sheath removal
4, 5, 6 Fr.
2.0 to 3.0 hours bed rest
post sheath removal
3M™ Tegaderm™ Transparent Film Dressing Frame
Style
1626, 1627, 1628, 1629, 1630, 1634, 1622W, 1623W,
1624W, 1626W, 9505W, 9506W
Description: Tegaderm™ Film consists of a thin film
backing with a non-latex, hypoallergenic adhesive.
Tegaderm™ Film with Border is notched and reinforced with
soft cloth tape to provide a better seal around catheters and
other devices. The dressing is breathable, allowing good
oxygen and moisture vapor exchange. It is waterproof and
impermeable to liquids, bacteria, and viruses. *An intact
dressing protects the site from outside contamination. *In
vitro testing shows that the film of Tegaderm™ and
Tegaderm™ HP dressings provides a viral barrier from
viruses 27nm in diameter or larger while the dressing
remains intact without leakage.
Indications: Tegaderm™ Film can be used to cover and
protect catheter sites and wounds, to maintain a moist
environment for wound healing or to facilitate autolytic
debridement, as a secondary dressing, as a protective cover
over at-risk skin, to secure devices to the skin, to cover first
and second degree burns, and as a protective eye covering.
Do not use the dressing as a replacement for sutures and
other primary wound closure methods.
42-0716-01 rev F 08/11 Precautions:
1.
Stop any bleeding at the site before applying the
dressing.
2.
Do not stretch the dressing during application as tension
can cause skin trauma.
3.
Make sure the skin is clean, free of soap residue and
lotion and allowed to dry thoroughly before applying
the dressing to prevent skin irritation and to ensure
good adhesion.
4.
The dressing may be used on an infected site, only
when under the care of a health care professional.
5.
Antimicrobial ointments containing polyethylene
glycols may compromise the strength of the
Tegaderm™ HP Transparent Film Dressings.
6.
Tegaderm™ Transparent Dressings should not be resterilized by gamma, E-beam or steam methods.
Instructions for Use: Refer to figures.
If you have any questions or comments, contact the 3M
Health Care Customer Help Line at 1-800-228-3957 OR GO TO WWW.3M.COM.
LIMITED WARRANTY
Vascular Solutions, Inc. warrants that the D-Stat Dry Silver
hemostatic bandage is free from defects in workmanship
and materials prior to the stated expiration date. Liability
under this warranty is limited to refund or replacement of
any product which has been found by Vascular Solutions,
Inc. to be defective in workmanship or materials. Vascular
Solutions, Inc. shall not be liable for any incidental, special,
or consequential damages arising from the use of the D-Stat
Dry Silver hemostatic bandage. Damage to the product
through misuse, alteration, improper storage, or improper
handling shall void this limited warranty.
No employee, agent, or distributor of Vascular Solutions,
Inc. has any authority to alter or amend this limited warranty
in any respect. Any purported alteration or amendment shall
not be enforceable against Vascular Solutions, Inc.
THIS WARRANTY IS EXPRESSLY IN LIEU OF ALL
OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER OBLIGATION OF VASCULAR SOLUTIONS, INC.
PATENTS AND TRADEMARKS
International and U.S. patents pending.
D-Stat® is a registered trademark of Vascular Solutions, Inc.
©2011 Vascular Solutions, Inc.
3
42-0716-01 rev F 08/11 ©2011 Vascular Solutions, Inc.
4
42-0716-01 rev F 08/11