Keep Access Sites Dry and Intact
Presentation Objectives
Gain an understanding of:
 The powder that will seal access sites and keep them dry
and intact by stopping bleeding or oozing
 How BioSeal can assist you in following CDC and Pedivan
guidelines for Catheter Site Assessment and Dressing
Change Regimens
 The study published in the Journal of the Association of
Vascular Access that showed how Florida Hospital
eliminated the 24-48 hour dressing change for all PICC
insertions
What is BioSeal CVC?
BioSeal CVC is a topical
powder made of a
hydrophilic polymer and
potassium ferrate.
The powder’s mechanism
of action forms an occlusive
seal to protect an access
site and keep it
dry and intact.
BioSeal CVC Powder
Colorized scanning electron microscopy
The Seal
The “BioSeal” allows “nothing
in, nothing out”.
 Occlusive seal
 Keeps microbial nutrients from
getting out
 Prevents microbes from getting in
 Alleviates need for the 24-48 hr
dressing change
 Minimizes unscheduled dressing
changes
Seal
Extra
powder
SEM photography of a 5 Fr. Catheter. Note the
occlusive seal that has formed around the line.
The Seal
Above the Seal
Bacteria full of water and salts come in
contact with the powder on the top side of
the seal (H2O & Ca++, Na+, K+)
2. The bacteria dries.
3. The moisture pulled from the bacteria contain
salts. The cations of these salts are exchanged
for H+ (acidic), creating a low pH environment
(~2) above the seal.
1.
Desiccation + Low pH (~ 2) = Microbial Barrier
Below the Seal
BioSeal Powder floats on the blood – it doesn’t
penetrate the seal. This results in a neutral pH below
the seal.
5 Fr catheter
BioSeal CVC - A Microbial Barrier
Microbial Strike-Through (Barrier) Test Results*
7-days Incubation
Test Sample
Control
NG
NG
NG
NG
NG
NG
NG
NG
G
G
G
G
G
G
G
G
S. aureus MRSA ATCC 33591a
S. epidermidis MRSE ATCC 51625 a
E. faecalis VRE ATCC 51575 a
S. aureus ATCC 6538 b
P. aureginosa ATCC 9027 b
E. coli ATCC 8739 b
C. albicans ATCC 10231 b
A. ATCC 16404 b
7-Day with Daily Rechallenge Test Results*
MRSA ATCC 33591
CFU at Initial
Contact
VRE ATCC 51575
Sample
Control
Sample
Control
Sample
Control
2.1 x 106
2.2 x 106
3.4 x 106
3.1 x 106
1.7 x 106
1.8 x 106
>5.2
>5.2
>5.2
>5.2
>5.2
>5.2
>5.2
NR
NR
NR
0.3
0.3
0.4
NR
There was a log reduction when BioSeal was used:
After 24 hours
After 48 hours
After 72 hours
After 96 hours
After 120 hours
After 144 hours
After 168 hours
MRSE ATCC 51625
>5.3
>5.3
>5.3
>5.3
>5.3
>5.3
>5.3
NR
NR
NR
0.2
0.3
NR
NR
>5.5
>5.5
>5.5
>5.5
>5.5
>5.5
>5.5
NR
NR
NR
NR
NR
NR
NR
* These data have not been evaluated by the Food and Drug Administration. Data recorded is log reduction.
CDC Guidelines
Guidelines for the
Prevention of
Intravascular CatheterRelated Infections
Replace catheter-site dressing if the
dressing becomes damp, loosened, or
visibly soiled (146,210). Category IB
Pedivan Guidelines
CVC Dressing: Assessment and Change
 Dressings that are dry and intact decrease catheter migration,
dislodgement, catheter damage, phlebitis, thrombosis, and
CRBSI (Sharpe, 2008).
 Change transparent semipermeable dressings (TSM) every 7
days (CDC 2002; INS 2006; Kline, 2005; Vandijck et al., 2009) and
more frequently in the presence of moisture, blood, drainage,
or if the dressing is not intact. Moisture under the CVC dressing
can proliferate the growth of microorganisms.
Pedivan Guidelines (cont’d)
CVC Dressing: Assessment and Change
 Based on the developmental level of the patient and underlying
diagnosis, the procedure for changing the CVC dressing can be
challenging due to anxiety or activity of the patient. Appropriate
planning and support is needed to prevent the risk of catheter
dislodgement, inward migration, damage, site contamination, or
skin damage (Keene et al., 2009; Sparks, Setlik, & Luhman, 2007).
 For many infants and children, dressing changes need to be a
scheduled procedure when optimal help is available. CVC dressing
changes by a specialized team may minimize catheter migration rates.
For infants and young patients, dressing changes are a 2--‐person
procedure.
“Prevention of CRBSI: Make it easy to do
the right thing and make it hard to do
the wrong thing.”
Faisal Masud M.D., FCCP
Medical Director,
Cardiovascular Intensive Care Unit
Methodist DeBakey Heart Center
Multiple, unplanned dressing changes are not “easy”
….especially for infants and young children!
BioSeal in
Pediatrics/NICU
Why BioSeal for Pediatrics/NICU?
 BioSeal is not contraindicated for patients
of any age
 Eliminates blood and exudate - nidus for
microbes
 Provides a microbial barrier
 Delivers excellent “atraumatic care” by
minimizing both planned and unplanned
dressing changes
 Eliminates variation- makes it easy to do the
right thing and hard to do the wrong thing
BioSeal in Pediatrics/NICU
BioSeal seals the site, stops
bleeding and oozing, and provides a
microbial barrier for:
 Pediatric PICC/CVC placement
 Circumcisions
 Cuts and lacerations
 Other procedures resulting in
external bleeding (including those
performed in Cardiac Cath labs –
BioSeal ADVANCED)
Children’s Hospitals Using BioSeal
 Children’s Hospital Boston
 Pediatric PICC Placement
 Children’s Hospital of Orange County, CA
 Emergency Department
 Children’s Hospital of Philadelphia, PA
 Interventional Radiology
 Children’s Mercy Hospital, Kansas City,
MO
 Pediatric PICC placement
 Children’s National Medical Center –
Washington DC
 Pediatric Urology
 Christus Santa Rosa Children’s Hospital,
TX
 Thrombophilia Center
 Clear Lake Regional Medical Center,
Webster, TX
• Circumcisions (Peds/Neonatal Nursery)
 Cook Children’s Hospital, Fort Worth,
TX
 Using for lacerations, circumcisions, CVCs
 Hematology/Oncology Center
 Phoenix Children’s Hospital, AZ

Pediatric PICC placement
 St. Louis Children’s Hospital, MO
 Pediatric PICC placement
 Cardiac Cath Lab
 Texas Children’s Hospital, TX
 Pediatric PICC placement
 Walt Disney Pavilion at Florida
Hospital Orlando, FL
 Pediatric PICC insertions
Evidence-Based
Practice
Current JAVA Study (Summer 2010)
Peer-reviewed clinical trial of BioSeal CVC usage
at Florida Hospital:
During a 39-day period, BIOSEAL CVC™ Powder
was evaluated for all PICC line insertions (418)
and for occasional bleeding at dressing changes
or line discontinuations.
Following product application, staff completed
written evaluations to:

Rate the efficacy of the powder as
compared to the controls, gauze and
oxidized cellulose gauze
 Record time to hemostasis
A post-hoc assessment of potential complications
such as infections, bleed through, skinimpressions or rash due to product use was also
conducted.
Current JAVA Study (Summer 2010)
Study Results:
 Results demonstrated an overwhelming user-preference for the powder relative to the
gauze control standard of care.
 Elimination of 48-hour dressing change
 ~40% reduction in Catheter-related Bloodstream Infections (CRBSIs) according to a
post-hoc review of documentation
 No site infections or other complications
 Skin integrity was ‘pristine’
The Florida Hospital system (7 campuses) has added
BioSeal CVC to their PICC line insertion protocol.
Infections & PICC Infection Rate (Period 1 vs. Period 2)
PICC Line
Days
Totals
PICCS
Inserted
PICC
Infection
Rate
Period
Months
No. PICC
Infections
Prior to
BioSeal
1
May-Oct
12
25232
3210
0.4756
W/
BioSeal
2
Nov-Apr
7
24323
2850
0.2878
Current JAVA Study (Summer 2010)
Other Significant Outcomes:
Reduced cost:
• Powder vs. cellulose gauze
• Reduced frequency of dressing changes
• Reduced time at the bedside with troubleshooting bleeding
and oozing PICC line sites
 There was no difference in efficacy based on patient
demographics or concomitant drug therapies.
• 79% of patients evaluated had high PT/INR levels at the time
of powder use
 Patient acuity did not change the effectiveness of the seal
• 85% of insertions are in upper level/ICU patients
St. Louis Children’s Hospital Trial
 Over an ~2 month period, BioSeal was evaluated for 84 patients,
ages 10 days to 26 yrs
 Trial objectives were to evaluate BioSeal CVC for:
 Efficacy of BioSeal CVC to stop leaking/oozing from PICC sites (compared
to gauze standard of care)
 Ability of BioSeal CVC to keep dressings dry and intact until scheduled
dressing change
 Ease of use
 Since the trial, SLCH has completely eliminated the 24-48 hour
dressing change for PICCs and added BioSeal to their PICC line
insertion protocol.
St. Louis Children’s Hospital Trial Results
BioSeal for Leaking/Oozing:
 94% reported BioSeal effectively stopped leaking and oozing as
compared to gauze
Scheduled Dressing Change (49 evaluations, many went home):
 100% dry and intact upon removal of dressing
 94% rated ease of removing powder as very good to excellent
 94% rated ease of redressing site as very good to excellent
BioSeal for Line Removal (5 evaluations):
 100% said BioSeal was easy to remove
 100% rated tissue integrity/condition of access site as very good to
excellent
St. Louis Children’s Hospital Data
BioSeal placed at all PICC sites from 9-2-10 to present
Total of 331 patients regardless of dx, age, hx, etc.
# Pts/Age in Days
#Pts/Age in Months
#Pts/Age in Years
29 pts < 30 days old
34 pts < 1 yr
268 pts from 1 yr to 26yrs
1 – 1 day
2 – 3 day
3 – 4 day
2 – 7 day
1 – 9 day
1 – 10 day
1 – 11 day
1 – 12 day
1 – 13 day
1 – 14 day
2 – 16 day
1 – 20 day
3 – 21 day
1 – 24 day
1 – 25 day
2 – 26 day
1 - 28 day
4 – 29 day
9 – 1 month
7 – 2 month
6 – 3 month
1 – 4 month
3 – 5 month
1 – 7 month
3 – 8 month
2 – 10 month
2 – 11 month
15 – 1 yr
24 – 2 yr
18 – 3 yr
15 – 4 yr
7 – 5 yr
13 – 6 yr
8 – 7 yr
11 – 8 yr
11 – 9 yr
12 –10 yr
18 –11yr
13 – 12 yr
17 – 13 yr
12 – 14yr
9 – 15 yr
17 – 16 yr
17 – 17 yr
6 – 18 yr
12 – 19 yr
7 – 20 yr
5 – 21 yr
1 – 26 yr
Protocols for Catheter
Insertion and Maintenance
Protocol for Catheter Insertion
Pour Powder
Hold Pressure
Seal is formed
Seal @ 7 days
In-service Topics
 Dressing Changes/Maintenance
 Pull Backs
 Discontinuation
 Powder Properties
 Use of PCD
Application Tips
Do’s
 Place securement device.
 Completely cover site with powder.
 Apply firm, continuous pressure for two minutes directly
over site with dry gloved fingers or non-adherent dressing
to form the protective seal and achieve hemostasis.
 Leave seal over site; it will fall off naturally on its own, or if
needed, may be removed with sterile technique.
Dry/intact dressing 0 to 7 days
Site with PCD cover
Application Tips
Don'ts
 Don’t hold pressure over BioSeal CVC Powder with gauze to avoid
tearing the seal.
 Don’t check for hemostasis before the recommended holding time.
This could disturb seal formation.
 Don’t use BioSeal internally as it is indicated for external bleeding.
Note: Upon application, a temporary warming or sensation may be felt
when holding pressure over the powder.
Conclusion
With BioSeal CVC you can:
 DO IT ONCE
 DO IT RIGHT
 LEAVE IT ALONE!
Remember………………..
“Quality is never an accident;
it’s always the result of high
intention, sincere effort;
intelligent direction and
skillful execution; it
represents the wise choice of
many alternatives.”
Thank you,
Dana Runde RN, CRNI dar7130@bjc.org
St. Louis Children’s Hospital