1. Keep Access Sites Dry and Intact

2. 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

3. 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. Colorized scanning electron microscopy BioSeal CVC Powder What is BioSeal CVC?

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

5. Above the Seal 1. Bacteria full of water and salts come in contact with the powder on the top side of the seal (H 2 O & 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. 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 The Seal

6. BioSeal CVC - A Microbial Barrier 7-days IncubationTest SampleControl S. aureus MRSA ATCC 33591 a NGG S. epidermidis MRSE ATCC 51625 a NGG E. faecalis VRE ATCC 51575 a NGG S. aureus ATCC 6538 b NGG P. aureginosa ATCC 9027 b NGG E. coli ATCC 8739 b NGG C. albicans ATCC 10231 b NGG A. ATCC 16404 b NGG Microbial Strike-Through (Barrier) Test Results* MRSA ATCC 33591VRE ATCC 51575MRSE ATCC 51625 SampleControlSampleControlSampleControl CFU at Initial Contact 2.1 x 10 6 2.2 x 10 6 3.4 x 10 6 3.1 x 10 6 1.7 x 10 6 1.8 x 10 6 There was a log reduction when BioSeal was used: After 24 hours>5.3NR>5.5NR>5.2NR After 48 hours>5.3NR>5.5NR>5.2NR After 72 hours>5.3NR>5.5NR>5.2NR After 96 hours>5.30.2>5.5NR>5.20.3 After 120 hours>5.30.3>5.5NR>5.20.3 After 144 hours>5.3NR>5.5NR>5.20.4 After 168 hours>5.3NR>5.5NR>5.2NR 7-Day with Daily Rechallenge Test Results * * These data have not been evaluated by the Food and Drug Administration. Data recorded is log reduction.

7. Replace catheter-site dressing if the dressing becomes damp, loosened, or visibly soiled (146,210). Category IB Guidelines for the Prevention of Intravascular Catheter- Related Infections CDC Guidelines

8. 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.

9. 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.

10. “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!

11. BioSeal in Pediatrics/NICU

12. 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

13. 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)

14. 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

15. Evidence-Based Practice

16. 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, skin- impressions or rash due to product use was also conducted.

17. 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) PeriodMonths No. PICC Infections PICC Line Days Totals PICCS Inserted PICC Infection Rate Prior to BioSeal 1May-Oct122523232100.4756 W/ BioSeal 2Nov-Apr72432328500.2878

18. 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

19. 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.

20. 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

21. 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 1 – 1 day 1 – 14 day 2 – 3 day 2 – 16 day 3 – 4 day 1 – 20 day 2 – 7 day 3 – 21 day 1 – 9 day 1 – 24 day 1 – 10 day 1 – 25 day 1 – 11 day 2 – 26 day 1 – 12 day 1 - 28 day 1 – 13 day 4 – 29 day 34 pts < 1 yr 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 268 pts from 1 yr to 26yrs 15 – 1 yr 13 – 12 yr 24 – 2 yr 17 – 13 yr 18 – 3 yr 12 – 14yr 15 – 4 yr 9 – 15 yr 7 – 5 yr 17 – 16 yr 13 – 6 yr 17 – 17 yr 8 – 7 yr 6 – 18 yr 11 – 8 yr 12 – 19 yr 11 – 9 yr 7 – 20 yr 12 –10 yr 5 – 21 yr 18 –11yr 1 – 26 yr

22. Protocols for Catheter Insertion and Maintenance

23. Protocol for Catheter Insertion Pour Powder Hold Pressure Seal is formed Seal @ 7 days

24. In-service Topics  Dressing Changes/Maintenance  Pull Backs  Discontinuation  Powder Properties  Use of PCD

25.  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. Do’s Application Tips Dry/intact dressing 0 to 7 daysSite with PCD cover

26.  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. Don'ts Application Tips

27. Conclusion With BioSeal CVC you can: DO IT ONCE  DO IT ONCE DO IT RIGHT  DO IT RIGHT LEAVE IT ALONE!  LEAVE IT ALONE!

28. 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