Keep Access Sites Dry and IntactKeep Access Sites Dry and Intact

Presentation ObjectivesPresentation ObjectivesGain 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 RegimensChange 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

What is BioSeal CVC?

BioSeal CVC is a topical powder made of a hydrophilic polymer and 

BioSeal CVC Powder

y p p ypotassium ferrate.

The powder’s mechanism of action forms an occlusive seal to protect an accessseal to protect an access site and keep it dry and intact

Colorized scanning electron microscopy

dry and intact. 

The SealThe Seal

The “BioSeal” allows “nothingThe  BioSeal  allows  nothing in, nothing out”. Occlusive seal

Extra powderSeal

Occlusive seal Keeps microbial nutrients from getting out Prevents microbes from getting in Alleviates need for the 24‐48 hrdressing changedressing change 

Minimizes unscheduled dressing changes

SEM photography of a 5 Fr. Catheter. Note the occlusive seal that has formed around the line.

The Seal

Above the Seal

The Seal

1. 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 dries2. 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.

Desiccation + Low pH (~ 2) = Microbial Barrier

Below the SealBioSeal Powder floats on the blood – it doesn’t penetrate the seal. This results in a neutral pH below pe e a e e sea s esu s a eu a p be othe seal. 5 Fr catheter

BioSeal CVC - A Microbial BarrierBioSeal CVC - A Microbial Barrier

7 days Incubation Test Sample Control

Microbial Strike-Through (Barrier) Test Results*7-days Incubation Test Sample ControlS. aureus MRSA ATCC 33591a NG GS. epidermidis MRSE ATCC 51625 a NG GE. faecalis VRE ATCC 51575 a NG GS. aureus ATCC 6538 b NG GP. aureginosa ATCC 9027 b NG GE. coli ATCC 8739 b NG GC. albicans ATCC 10231 b NG GA. ATCC 16404 b NG G

MRSA ATCC 33591 VRE ATCC 51575 MRSE ATCC 51625

Sample Control Sample Control Sample ControlCFU at Initial 2 1 x 106 2 2 x 106 3 4 x 106 3 1 x 106 1 7 x 106 1 8 x 106

7-Day with Daily Rechallenge Test Results*

Contact 2.1 x 106 2.2 x 106 3.4 x 106 3.1 x 106 1.7 x 106 1.8 x 106

There was a log reduction when BioSeal was used:After 24 hours >5.3 NR >5.5 NR >5.2 NRAfter 48 hours >5.3 NR >5.5 NR >5.2 NRAfter 72 hours >5.3 NR >5.5 NR >5.2 NRAfter 96 hours >5 3 0 2 >5 5 NR >5 2 0 3After 96 hours >5.3 0.2 >5.5 NR >5.2 0.3After 120 hours >5.3 0.3 >5.5 NR >5.2 0.3After 144 hours >5.3 NR >5.5 NR >5.2 0.4After 168 hours >5.3 NR >5.5 NR >5.2 NR

* These data have not been evaluated by the Food and Drug Administration. Data recorded is log reduction.

CDC Guidelines

Guidelines for the 

CDC Guidelines

Prevention of Intravascular Catheter‐Intravascular CatheterRelated Infections

Replace catheter‐site dressing if the d i b d l ddressing becomes damp, loosened, or visibly soiled (146,210). Category IB

Pedivan GuidelinesPedivan Guidelines

i d hCVC 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,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)Pedivan Guidelines (cont d)

CVC D i A t d ChCVC Dressing: Assessment and Change

Based on the developmental level of the patient and underlying diagnosis the procedure for changing the CVC dressing can bediagnosis, 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 g , g , g , ,skin damage (Keene et al., 2009; Sparks, Setlik, & Luhman, 2007).

For many infants and children dressing changes need to be a 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--‐personFor infants and young patients, dressing changes are a 2 person procedure.

“Prevention of CRBSI: Make it easy to doPrevention of CRBSI: Make it easy to do the right thing and make it hard to do th thi ”the wrong thing.” 

Faisal Masud M.D., FCCPMedical Director, Cardiovascular Intensive Care UnitM h di D B k H CMethodist DeBakey Heart Center

Multiple, unplanned dressing changes are not “easy”p p g g y….especially for infants and young children!

BioSeal in P di t i /NICUPediatrics/NICU

Why BioSeal for Pediatrics/NICU?Why BioSeal for Pediatrics/NICU?

BioSeal is not contraindicated for patients fof any age

Eliminates blood and exudate - nidus for microbes

Provides a microbial barrierProvides a microbial barrier

Delivers excellent “atraumatic care” by minimizing both planned and unplannedminimizing both planned and unplanned dressing changes

Eli i t i ti k it t d th Eliminates variation- makes it easy to do the right thing and hard to do the wrong thing

BioSeal in Pediatrics/NICUBioSeal in Pediatrics/NICU

BioSeal seals the site stopsBioSeal seals the site, stops bleeding and oozing, and provides a microbial barrier for:

Pediatric PICC/CVC placement CircumcisionsCircumcisions Cuts and lacerations Other procedures resulting in

external bleeding (including those performed in Cardiac Cath labs –BioSeal ADVANCED))

Children’s Hospitals Using BioSealChildren s Hospitals Using BioSeal Children’s Hospital Boston

Pediatric PICC Placement Cook Children’s Hospital, Fort Worth,

TX Using for lacerations circumcisions CVCs

Children’s Hospital of Orange County, CA Emergency Department

Children’s Hospital of Philadelphia, PA

Using for lacerations, circumcisions, CVCs Hematology/Oncology Center

Phoenix Children’s Hospital, AZ Pediatric PICC placement

Interventional Radiology

Children’s Mercy Hospital, Kansas City, MO Pediatric PICC placement

St. Louis Children’s Hospital, MO Pediatric PICC placement Cardiac Cath Lab

Pediatric PICC placement

Children’s National Medical Center –Washington DC Pediatric Urology

Texas Children’s Hospital, TX Pediatric PICC placement

Walt Disney Pavilion at Florida H it l O l d FLPediatric Urology

Christus Santa Rosa Children’s Hospital, TX Thrombophilia Center

Hospital Orlando, FL Pediatric PICC insertions

Clear Lake Regional Medical Center, Webster, TX• Circumcisions (Peds/Neonatal Nursery)

Evidence-Based Practice

Current JAVA Study (Summer 2010)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 discontinuationsor 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 Record time to hemostasis

A post-hoc assessment of potential complications such as infections, bleed through, skin-impressions or rash due to product use was alsoimpressions or rash due to product use was also conducted.

Current JAVA Study (Summer 2010)Current JAVA Study (Summer 2010)Study Results: Results demonstrated an overwhelming user-preference for the powder relative to the

gauze control standard of care.gauze control standard of care.

Elimination of 48-hour dressing change

~40% reduction in Catheter-related Bloodstream Infections (CRBSIs) according to apost-hoc review of documentationpost-hoc review of documentation

No site infections or other complications

Skin integrity was ‘pristine’

The Florida Hospital system (7 campuses) has addedBioSeal CVC to their PICC line insertion protocol.

I f ti & PICC I f ti R t (P i d 1 P i d 2)Infections & PICC Infection Rate (Period 1 vs. Period 2)

Period MonthsNo. PICC Infections

PICC Line Days

Totals PICCS

Inserted

PICC Infection

Rate

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)Current JAVA Study (Summer 2010)

Other Significant Outcomes:R d d tReduced cost:

• Powder vs. cellulose gauze• Reduced frequency of dressing changes• Reduced time at the bedside with troubleshooting bleeding

and oozing PICC line sitesThere was no difference in efficacy based on patient y p

demographics or concomitant drug therapies.• 79% of patients evaluated had high PT/INR levels at the time

of powder useo po de usePatient acuity did not change the effectiveness of the seal

• 85% of insertions are in upper level/ICU patients

St Louis Children’s Hospital TrialSt. Louis Children s Hospital Trial

Over an ~2 month period, BioSeal was evaluated for 84 patients, ages 10 da s to 26 rsages 10 days to 26 yrs

Trial objectives were to evaluate BioSeal CVC for:j 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 scheduledAbility 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 i ti t linsertion protocol.

St Louis Children’s Hospital Trial ResultsSt. Louis Children s Hospital Trial ResultsBioSeal for Leaking/Oozing:

94% reported BioSeal effectively stopped leaking and oozing as94% reported BioSeal effectively stopped leaking and oozing as compared to gauze

Scheduled Dressing Change (49 evaluations, many went home):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 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 DataSt. Louis Children s Hospital Data

BioSeal placed at all PICC sites from 9-2-10 to presentTotal of 331 patients regardless of dx, age, hx, etc.

# Pts/Age in Days #Pts/Age in Months #Pts/Age in Years29 pts < 30 days old 34 pts < 1 yr 268 pts from 1 yr to 26yrs29 pts < 30 days old

1 – 1 day 1 – 14 day2 – 3 day 2 – 16 day3 – 4 day 1 – 20 day

34 pts < 1 yr9 – 1 month7 – 2 month6 – 3 month

268 pts from 1 yr to 26yrs15 – 1 yr 13 – 12 yr24 – 2 yr 17 – 13 yr18 – 3 yr 12 – 14yry y

2 – 7 day 3 – 21 day1 – 9 day 1 – 24 day1 – 10 day 1 – 25 day1 11 day 2 26 day

1 – 4 month3 – 5 month1 – 7 month3 8 month

y y15 – 4 yr 9 – 15 yr

7 – 5 yr 17 – 16 yr13 – 6 yr 17 – 17 yr

8 7 yr 6 18 yr1 – 11 day 2 – 26 day1 – 12 day 1 - 28 day 1 – 13 day 4 – 29 day

3 – 8 month2 – 10 month2 – 11 month

8 – 7 yr 6 – 18 yr11 – 8 yr 12 – 19 yr11 – 9 yr 7 – 20 yr12 –10 yr 5 – 21 yr18 –11yr 1 – 26 yr

Protocols for Catheter Insertion and Maintenance

Protocol for Catheter InsertionProtocol for Catheter Insertion

Pour Powder

Hold Pressure

Seal is formed

Seal @ 7 days

In-service TopicsIn-service Topics

Dressing Changes/Maintenance

P ll B k Pull Backs

DiscontinuationDiscontinuation

Powder Propertiesp

Use of PCD

Application Tips

Place securement device.Do’s

Application Tips

Completely cover site with powder.

Apply firm, continuous pressure for two minutes directly pp y p yover 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 yneeded, may be removed with sterile technique.

Dry/intact dressing 0 to 7 days Site with PCD cover

Application Tips

Don'ts

Application Tips

Don’t hold pressure over BioSeal CVC Powder with gauze to avoidtearing 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 Conclusion

With BioSeal CVC you can:With BioSeal CVC you can:

DO IT ONCEDO IT ONCEDO IT ONCEDO IT ONCE

DO IT RIGHTDO IT RIGHT DO IT RIGHTDO IT RIGHT

LEAVE IT ALONE!LEAVE IT ALONE! LEAVE IT ALONE!LEAVE IT ALONE!

RememberRemember………………..

“Quality is never an accident;it’s always the result of high

intention, sincere effort;intelligent direction and

skillful execution; itskillful execution; itrepresents the wise choice of

many alternatives.”

Thank you,y ,Dana Runde RN, CRNI dar7130@bjc.org

St. Louis Children’s Hospital