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           

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.

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.

Prior to study - Soiled dressing at insertion site. 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 Prior to study - Soiled dressing at insertion site. At time of study, VAS team included 23 certified PICC RNs and 8 RNs trained in the maintenance and care of PICC lines.

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

Current Study of CHG Sponge Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes Jean-François Timsit, MD, PhD (March 2009) Decreased the risk of major CRBSIs by 60% “However, unscheduled dressing changes for soiling and leakage were common.” (40-50% unplanned) 6

Make it Easy! “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”.

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* Powder Control Time Saved Time to Hemostasis following Venous Access Procedures 1.93 min 3.96 min 2.0 min *Wang, D.S., Chu, L.F. , et al. 2008. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures. Journal of Vascular and Interventional Radiology

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

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.

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. BioSeal CVC Powder Colorized scanning electron microscopy

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

The Seal Above the Seal Below 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. Photo is colorized version of an scanning electron microscopy of a 5 fr catheter. 5 Fr catheter

7-Day with Daily Rechallenge Test Results* The Powder as a Microbial Barrier Microbial Strike-Through (Barrier) Test Results* 7-days Incubation Test Sample Control S. aureus MRSA ATCC 33591a NG G 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 VRE ATCC 51575 MRSE ATCC 51625 Sample Control CFU at Initial 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 Log Reduction After 24 hours >5.3 NR >5.5 >5.2 After 48 hours After 72 hours After 96 hours 0.2 0.3 After 120 hours After 144 hours 0.4 After 168 hours * Data not evaluated by the Food and Drug Administration. 14

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

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.

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. 44% 38% 12% 4%

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

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

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.

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). Insertion site with BioSeal CVC Powder Dry/intact dressing – 0-7 days *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?

Implications for Practice Procedural Cost Analysis Cost/Benefit Analysis Surgicel BioSeal Savings Nursing Cost Per Hour $43.17   Hours per work shift 12 # dressing changes per Hour 2 Average # dressing changes per work shift 24 Nursing cost for dressing change $21.59 Average cost of dressing change kit $4.77 Total Cost of Nursing time per Hour $26.36 If Bleeding Complications: Cost of additional products: $58.00 $20.00 % of time additional products use: 20% 100% Total Cost if Bleeding Complications: $11.60 -$8.40 Cost of Dressing Change after 24 Hours Total Cost of Patient Care $64.32 $46.36 $17.96 # of PICCS/Month 500 Cost Per Month $32,160.00 $23,180.00 $8,980.00 Cost Per Year $385,920.00 $278,160.00 $107,760.00

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.

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.

Powder Application Application training is key Use of the PCD Forms a ‘pill’, edges as deep as the center Powder properties, flow out Leave the PCD in place, cover with dressing

Application and 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

Questions?