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 followingdisclosures:

• 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.

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.

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

Current Study of CHG Sponge

Chlorhexidine-Impregnated Sponges and Less Frequent Dressing ChangesJean-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)

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

Faisal Masud M.D., FCCPMedical Director, Cardiovascular Intensive Care UnitMethodist DeBakey Heart Center

Multiple, unplanned dressing changes are not “easy”.

Make it 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*

1.93 min 3.96 min 2.0 min

Powder Control Time Saved

*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

Time to Hemostasis following Venous Access Procedures

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.

Colorized scanning electron microscopy

BioSeal CVC Powder

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

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

Extra powderSeal

Above the Seal1. 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.

Desiccation + Low pH (~ 2) = Microbial Barrier

Below the SealThe 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

The Powder as a Microbial Barrier

7-days Incubation Test Sample Control

S. aureus MRSA ATCC 33591a NG GS. epidermidis MRSE ATCC 51625 a

NG G

E. 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

Microbial Strike-Through (Barrier) Test Results*

MRSA ATCC 33591 VRE ATCC 51575 MRSE ATCC 51625Sample Control Sample Control 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 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 120 hours

>5.3 0.3 >5.5 NR >5.2 0.3

After 144 hours

>5.3 NR >5.5 NR >5.2 0.4

After 168 hours

>5.3 NR >5.5 NR >5.2 NR

7-Day with Daily Rechallenge Test Results*

* Data not evaluated by the Food and Drug Administration.

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 MethodsType 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.

Product Effectively Stops Bleeding Rating and No. of Responses

(scale 1-6, 1=poor, 6=excellent)

0 50 100 150 200

1

3

5

Rat

ing

# of Responses

# of responses

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

Implications for PracticeProcedural Cost Analysis

Cost/Benefit Analysis Surgicel BioSeal Savings

Nursing Cost Per Hour $43.17 $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 $21.59  

Average cost of dressing change kit $4.77 $4.77  

Total Cost of Nursing time per Hour $26.36 $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 $20.00 -$8.40

       

Cost of Dressing Change after 24 Hours $26.36 0  

       

Total Cost of Patient Care $64.32 $46.36 $17.96

       

# of PICCS/Month 500 500  

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

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 PCDForms a ‘pill’, edges as deep as the center

Powder properties, flow out

Leave the PCD in place, cover with dressing

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

Questions?