The Science of a Seal for PICC Line Management: An Alternative Hemostatic Agent That Keeps Sites Dry and Intact

1. The Science of a “Seal” for PICC Line Management: An Alternative Hemostatic Agent That Keeps Sites Dry and Intact Lauren Blough, RN, BS, CRNI; Kathy Hinson, RN, MN, MBA, MPH; Louis M. Guzzi, MD, FCCM           

2. Disclosures Lauren Blough, RN, BS, CRNI has the following disclosures: Lauren provides paid consulting services to Biolife, LLC, product manufacturer Biolife LCC is providing payment for author/presenter’s travel and lodging expenses There is corporate support for this session. Biolife’s financial support has made this session possible.

3. Introduction The Venous Access Services (VAS) team of Florida Hospital identified an alternative hemostatic agent for PICC line management to improve patient outcomes and achieve time and financial savings. Florida Hospital is a 1200 bed facility, part of the Adventist Health System.Florida Hospital is a 1200 bed facility, part of the Adventist Health System.

4. Background Prior to study, the VAS team was: Using a gauze wick on every PICC site to control bleeding Using oxidized cellulose gauze in approximately 20% of cases (for problematic bleeding) Changing dressings at 48 hours At time of study, VAS team included 23 certified PICC RNs and 8 RNs trained in the maintenance and care of PICC lines.At time of study, VAS team included 23 certified PICC RNs and 8 RNs trained in the maintenance and care of PICC lines.

5. Replace catheter-site dressing if the dressing becomes damp, loosened, or visibly soiled (146,210). Category IB

7. “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

8. How We Got Started August 2007 ED presented to our product committee Approved for use in ED for un-sutureable wounds VAS saw the potential for PICC on insertion Approved for an evaluation Prior to this BioSeal had only been used on line removals: JVIR study*

9. How We Got Started Education began to the VAS team at FH Orlando Product reps trained and precepted EVERY PICC nurse on VAS team with three clinical applications- 26 nurses at the time

10. Purpose of Study To assess the ability of an alternative hemostatic agent to achieve hemostasis for PICC line insertions and to eliminate the 48 hour dressing change.

11. What is BioSeal CVC? A topical powder made of a hydrophilic polymer and a potassium ferrate. The powder’s mechanism of action forms an occlusive seal to protect an access site and keep it dry and intact.

12. The Seal The seal created by the powder allows “nothing in, nothing out”. Keeps microbial nutrients from getting out Prevents microbes from getting in Minimizes unscheduled dressing changes meaning less exposure to potential microbes 

13. 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+) The bacteria dries. 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 The powder floats on the blood – it doesn’t penetrate the seal. This results in a neutral pH below the seal. The Seal Photo is colorized version of an scanning electron microscopy of a 5 fr catheter.Photo is colorized version of an scanning electron microscopy of a 5 fr catheter.

15. BioSeal vs. CHG Products BioSeal CVC Engineers the human error out of the process – applying powder and dressing site at insertion keeps sites dry and intact for 7 days. Eliminates 48 dressing change and unplanned dressing changes. Cost-effective; can replace hemostats and infection control products CHG Products In disc form, can be applied incorrectly In gel and disc form, absorbs fluid which dampen dressing requiring a dressing change Studies show that unscheduled dressing changes are required 40-50% of the time due to reaching maximum absorption levels

16. Study Methods Type of study Observational Study Convenient Sample 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. Major Outcomes 98% of respondents considered the powder effective for controlling PICC line access site bleeding The powder effectively stopped bleeding in = 2 minutes in 94% of applications.

18. Major Outcomes ~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’. Reduced cost: - Powder vs. cellulose gauze - Reduced frequency of dressing changes - Reduced time at the bedside with troubleshooting bleeding and oozing PICC line sites

19. Major Outcomes 79% of patients evaluated had high PT/INR levels at the time of powder use Effective hemostasis Patient acuity did not change the effectiveness of the seal 85% of insertions are in upper level/ICU patients

20. Conclusions Results demonstrated an overwhelming user-preference for the powder relative to the gauze control standard of care. The product was considered to be effective in controlling PICC line access site bleeding. There was no difference in efficacy based on patient demographics or concomitant drug therapies. Extended post trial use of the product demonstrated the complete elimination of the 48-hour dressing change and a significant decrease in CRBSIs.

21. Implications for Practice Florida Hospital has eliminated the 48-hour dressing change and added BioSeal CVC Powder to PICC line insertion protocol and now perform initial dressing change at 7 days. In addition to a decrease in CRBSIs, the hospital has realized efficiencies through: Decreased nursing time Cost savings (fewer dressing kits) Perceived patient comfort (fewer site manipulations and complications). *Reduction in variation is also important. Reducing the number of steps in a bundle is important to both the clinician and patient. Mention FL Hospital recognition from the Joint Commission?*Reduction in variation is also important. Reducing the number of steps in a bundle is important to both the clinician and patient. Mention FL Hospital recognition from the Joint Commission?

22. Implications for Practice

23. Implications for Practice Next Steps for Florida Hospital: Air Embolism Prevention: use the powder on all central line removals, not PICC (implemented March 2010) Place on all central line insertions in addition to PICC AE decision is on CLs not PICCs. This will roll out in the 4th qtr of 2009. Q – What has happened since your trial? We have placed 22,088 PICCs as of Labor Day with zero adverse events using 75nurses; CRBSIs were reduced 48% in the 8months prior to BioSeal compared to the most recent 8months, reinforcing the results found in the trial. AE decision is on CLs not PICCs. This will roll out in the 4th qtr of 2009. Q – What has happened since your trial? We have placed 22,088 PICCs as of Labor Day with zero adverse events using 75nurses; CRBSIs were reduced 48% in the 8months prior to BioSeal compared to the most recent 8months, reinforcing the results found in the trial.

24. Publication of Study Study was one of four podium presentations selected for the at Association of Vascular Access (AVA) Annual Conference, September 2009 Also presented in poster format at the same conference Published in the Journal of the Association of Vascular Access (JAVA), Summer 2010, 15:2, 66-73.

25. Powder Application

26. Application and Removal Removal Naturally falls off at approx. 7 days Can be removed with NS Line Removal and ‘THE TUG’ One of the ‘ah-ha’ moments Seal that exists around the line in the skin tract

27. Questions?