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18th AVA Conference, Vancouver, Sept 19, 2004AVA TRANSPARENT

POLYURETHANE IV CATHETER DRESSING WORKSHOP

Dennis G. Maki, MD Section of Infectious Diseases

Department of Medicine

Center for Trauma and Life Support

University of Wisconsindgmaki@medicine.wisc.edu

SHORT-TERM INTRAVASCULAR DEVICES

• Defined: usually used <10 days• Types:

– Peripheral IV catheters– Arterial catheters for hemodynamic

monitoring– Noncuffed and nontunnelled CVCs

• Multilumen CVCs• PA Swan-Ganz catheters• Dual-lumen hemodialysis catheters

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LINE SEPSIS IN 2004Prevention

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LINE SEPSIS IN 2004Pathogenesis

PATHOGENESIS OF INFECTION WITH INTRAVASCULAR DEVICES

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RISK FACTORS FOR CVC-RELATED BSIBASED ON PROSPECTIVE STUDIES AND

MULTIVARIATE ANALYSIS

0.2 - 0.69Anti-infective catheter surface

0.4 - 15.13Tunneled short-term ICU CVC0.2 - 0.33Systemic antimicrobial therapy

2.5 - 8.77Duration catheterization > 7 d

0.2 - 0.33Cutaneous antisepticChlorhexidine vs Povidone-Iodine

1.6 - 9.07Guidewire exchange

2.7 - 4.37Access: IJ > Subclavian

5.5 - 13.25Heavy colonization (>103CFU) of insertion site

Risk RatioNo. StudiesFactor

Safdar N and Maki DG, Medicine (2002)

RISK FACTORS FOR CVC-RELATED BSIBASED ON PROSPECTIVE STUDIES AND

MULTIVARIATE ANALYSIS

0.2 - 0.69Anti-infective catheter surface0.4 - 15.13Tunneled short-term ICU CVC

0.2 - 0.33Systemic antimicrobial therapy

2.5 - 8.77Duration catheterization > 7 d

0.2 - 0.33Cutaneous antisepticChlorhexidine vs Povidone-Iodine

1.6 - 9.07Guidewire exchange

2.7 - 4.37Access: IJ > Subclavian

5.5 - 13.25Heavy colonization (>103CFU) of insertion site

Risk RatioNo. StudiesFactor

Safdar N and Maki DG, Medicine (2002)

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MICROBIAL PROFILE OF IVD-RELATED BSI Meta-analysis of 159 Studies

Hickmans, ports, PICCs, cuffed HD CVCs

% of Total

3501325865Long-term CVCs:

PIVCs, non-cuffed CVCs, Art lines

11152640592Short-term, percutaneous:

Yeasts

GNRs

S. aureus

CNSNo. IVD-Related

BSIs

Kluger DM and Maki DG (2000)

LINE SEPSIS IN 2004Prevention

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Trends in BSI rates*, by ICU type and year –NNIS, U.S. 1990-1999

CDC-NNIS. MMWR 49:149-53 (2000).*Per 1000 days a central line was used.

2002 HICPAC GUIDELINE FOR PREVENTION OF INTRAVASCULAR DEVICE-RELATED INFECTIONS

GENERALHCW education IASurveillance: hospital rates; patients IA

INSERTIONGloves for all handling of the device IBSpecial IV Teams desirable IASterile gloves, gowns, drapes for CVCs IAAlcohol, Pov-I2 , Tincture I2 or Tinct Chlorhex IASterile gauze or polyurethane dressings IACVCs: Subclavian preferred to IJ IANo prophylactic antibiotics IA

Use of anti -infective-coated CVC, if high rate IVD BSI IAUse of anti -infective lock solution for permanent IVDs, if recurrent IVD BSIs IB

Remove device ASAP IAFOLLOW-UP CARE

Daily surveillance of patient, site IBReplacement of catheters

PIVCs every 48- 72 hrs IAArterial catheters > 7d IBNoncuffed CVCs: NOT routinely IB

Guidewire exchangesNo evidence infection: OK IBDocumented infection: avoid IA

Compound admixtures in central pharmacy IB

Infect Control Hosp Epidemiol, Am J Infect Control, Crit Care Med (2002)

HICPAC GUIDELINE SCORINGIA. Strongly recommended,…

strong supportive scientific data

IB. Strongly recommended,…moderate supportive data

IC. Required by State or Federal regulations

II. Suggested for implementation,…theoretical rationale…

Unresolved Issue. No recommendation

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2002 HICPAC GUIDELINE FOR PREVENTION OF INTRAVASCULAR DEVICE-RELATED INFECTIONSGENERAL

HCW education IASurveillance: hospital rates; patients IA

INSERTIONGloves for all handling of the device IBSpecial IV Teams desirable IASterile gloves, gowns, drapes for CVCs IAAlcohol, Pov-I2 , Tincture I2 or Tinct Chlorhex IA

Sterile gauze or polyurethane dressings IACVCs: Subclavian preferred to IJ IANo prophylactic antibiotics IAUse of anti -infective-coated CVC, if high rate IVD BSI IAUse of anti -infective lock solution for permanent IVDs, if recurrent IVD BSIs IB

Remove device ASAP IAFOLLOW-UP CARE

Daily surveillance of patient, site IBReplacement of catheters

PIVCs every 48- 72 hrs IAArterial catheters > 7d IBNoncuffed CVCs: NOT routinely IB

Guidewire exchangesNo evidence infection: OK IBDocumented infection: avoid IA

Compound admixtures in central pharmacy IB

Infect Control Hosp Epidemiol, Am J Infect Control, Crit Care Med (2002)

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Why Would We Switch From Gauze to a Transparent Film Dressing?

1. See the site at all times

2. More comfortable for most patients3. Not going to saturate the site for

washing/showering4. May help immobilize the device more

effectively than a gauze dressing

Components of Transparent Dressings

PolyurethaneFilm

HypoallergenicAdhesive

50 um {

Are Transparent Dressings Permeable or Occlusive?

• Are commercial Polyurethane dressings Semi -permeable or Occlusive?

• Precise definitions:– Permeable (window screen, gauze)– Variable Permeable (skin)– Totally Occlusive (cellophane, Saran Wrap)

– Semi-permeable (polyurethane IV dressings)

Occlusive PorousSemi-Permeable

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What is Semi-permeable?

Selective Barriers—Impermeable to liquids, bacteria (and some to viruses), yet water vapor, oxygen and carbon dioxide readily pass through

What Methods Do Manufacturers Use to Measure Permeability?

Laboratory Bench Tests of MVTR:1. Inverted Beaker 2. Upright Beaker3. Evaporimeter

MVTR Defined• Moisture Vapor Transmission Rate

• Amount of moisture vapor which passes through a membrane in a given time period

• Measured under controlled conditions

• Not a single value – dependent on test method and conditions of test

• No ideal MVTR has been identified

Occlusive PorousSemi-Permeable

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Weighing the Test Beaker

Beakers in the Oven

Final Weighing of the Test Beaker

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Direct Evaporimetery

What Does This Mean in the Clinical Setting?

• Studies have shown no material differences between various MVTR numbers and skin colonization under the dressing, IV catheter colonization or, especially, CRBSI.

What Do The Clinical Outcome Studies

of Polyurethane Dressings on IV Catheter Insertion Sites—

the Prospective Randomized Trials—Show?

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EPISODES OF LOCAL CATHETER-RELATED INFECTIONS AND CATHETER-RELATED SEPSIS

IN 115 PATIENTS RECEIVINGDRY GAUZE OR TRANSPARENT DRESSING

.0150/347/42 (16.6)Catheter -related sepsis

.0028/34 (24)26/42 (62)Local catheter related

PGauzeTransparentInfection

No. of infected patients/no. who

received dressing (%)

Conly, et al. J Infect Dis (1989)

PROSPECTIVE RANDOMIZED TRIAL OF POLYURETHANE VS GAUZE DRESSINGS ON PERIPHERAL IV CATHETERS

Dressing Regimen

2.55+1.412.85+2.091.83+0.492.41+1.5Mean log CFUs + SD on infected catheters

0000Yeasts

0000Gram-negative bacilli

2 (0.4)000Staphylococcus aureus

24 (4.8)30 (6.1)24 (4.6)25 (4.6)Coagulase-negative staphylococci

Infecting organism, no. (%)

0000Bacteremia

26 (5.2)32 (6.1)24 (4.6)25 (4.6)Local ( >15 CFUs)†

Catheter-related inf., no. (%)

Iodophor -Transparent

(n=498)

TransparentIndefinite(n=527)

Gauze, Indefinite(n=519)

Gauze2d

(n=544)Parameter*

Maki et al , JAMA 258:2396 (87)

PROSPECTIVE RANDOMIZED STUDY OF TWO POLYURETHANE DRESSINGS FOR PA CATHETERS

7 (1)32Candida species11Enterococcus

25* (2)Gram-negative bacilli21Staphylococcus aureus

27 (1)28 (1)17Coagulase-negative staphylococciInfecting organisms, no. [septicaemia]

2 (1.1)1 (0.8)2 (1.6)With septicaemia (%)38 (20.5)32 (25.2)26 (20.0)Local infection (%)

185127130No. catheters studied

OpSite™IV 3000 5d

Tegaderm™5d

Gauze2d

Dressing Group

*P<0.05, compared with the Tegaderm group

Maki et al., Crit Care Med (1995)

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PROSPECTIVE MULTCENTER TRIAL OF A HYPERPERMEABLE POLYURETHANE DRESSING

1Candida species

1Gram-negative bacilli21Staphylococcus aureus

33Coagulase-neg staphylococciBSI organisms:

0.765 (2.5%)6 (3.1%)CVC-related BSI

.1331 (15.2%)19 (10.0%)> 103 cfu

.0346 (22.5%)26 (13.6%)Sonication > 102 cfu

.00667 (32.8%)39 (20.4%)SQ > 15 cfuColonized CVCs

204191No. catheters studied

P-ValueTegaderm™

HPGauze

Maki, Mermel, and Martin, ICAAC (1995)

META-ANALYSIS OF PROSPECTIVE RANDOMIZED TRIALS OF TRANSPARENT POLYURETHANE

DRESSINGS ON CENTRAL VENOUS CATHETERS

27 / 1067 (2.5%)19 / 711 (2.7)Pooled

5 / 204 (2.5)6 / 191 (3.1)Maki ’96

3 / 312 (1.0)2 / 130 (1.6)Maki ’947 / 42 (16.7)0 / 34 (…)Conly ’89

2 / 132 (1.5)1 / 36 (2.8)Young ’862 / 60 (3.3)1 / 75 (1.3)Anderson ’86

1 / 95 (1.0)5 / 111 (4.5)Powell ’857 / 222 (3.2)4 / 134 (3)Maki ’82

TransparentGauzeFirst AuthorNo. CVC-Related BSIs / No. CVCs (%)

Weighted RR 1.06 CI95 0.59 – 1.90 P = 0.85Maki et al., SHEA (1997)

“Super-permeable” IV Dressings

• There are no data to support claims/inferences that higher MVTR numbers, vis-a-vis, “super-permeable dressings” correlate to:– Significantly less bacterial colonization on the skin

beneath the dressing

– A significantly lower incidence of catheter colonization

– A reduced incidence of CRBSI

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PROSPECTIVE RANDOMIZED STUDY OF TWO POLYURETHANE DRESSINGS FOR PA CATHETERS

7 (1)32Candida species

11Enterococcus25* (2)Gram-negative bacilli

21Staphylococcus aureus27 (1)28 (1)17Coagulase-negative staphylococci

Infecting organisms, no. [septicaemia]2 (1.1)1 (0.8)2 (1.6)With septicaemia (%)

38 (20.5)32 (25.2)26 (20.0)Local infection (%)185127130No. catheters studied

OpSite™IV 3000

5d

Tegaderm™5d

Gauze2d

Dressing Group

*P<0.05, compared with the Tegaderm group

Maki et al., Crit Care Med (1995)

PROSPECTIVE MULTCENTER TRIAL OF A HYPERPERMEABLE POLYURETHANE DRESSING

1Candida species

1Gram-negative bacilli21Staphylococcus aureus

33Coagulase-neg staphylococciBSI organisms:

0.765 (2.5%)6 (3.1%)CVC-related BSI

.1331 (15.2%)19 (10.0%)>103 cfu

.0346 (22.5%)26 (13.6%)Sonication >102 cfu

.00667 (32.8%)39 (20.4%)SQ > 15 cfuColonized CVCs

204191No. catheters studied

P-ValueTegaderm™

HPGauze

Maki, Mermel, and Martin, ICAAC (1995)

2002 HICPAC GUIDELINE FOR PREVENTION OF INTRAVASCULAR DEVICE-RELATED INFECTIONSGENERAL

HCW education IASurveillance: hospital rates; patients IA

INSERTIONGloves for all handling of the device IBSpecial IV Teams desirable IASterile gloves, gowns, drapes for CVCs IAAlcohol, Pov-I2 , Tincture I2 or Tinct Chlorhex IA

Sterile gauze or polyurethane dressings IACVCs: Subclavian preferred to IJ IANo prophylactic antibiotics IAUse of anti -infective-coated CVC, if high rate IVD BSI IAUse of anti -infective lock solution for permanent IVDs, if recurrent IVD BSIs IB

Remove device ASAP IAFOLLOW-UP CARE

Daily surveillance of patient, site IBReplacement of catheters

PIVCs every 48- 72 hrs IAArterial catheters > 7d IBNoncuffed CVCs: NOT routinely IB

Guidewire exchangesNo evidence infection: OK IBDocumented infection: avoid IA

Compound admixtures in central pharmacy IB

Infect Control Hosp Epidemiol, Am J Infect Control, Crit Care Med (2002)

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Places Where Dr. Maki Does Not Use a Transparent Dressing

• Profoundly Diaphoretic Patients (Once diaphoresis controlled, transparent dressing fine)

• Burn Wound Device• Exquisitely Sensitive Skin (Chronic Skin

Condition)

Why Do the KDOQI Guidelines Say that “transparent film

dressings pose a greater threat of exit site colonization”

• Based on the Conly et al 1989 study (in Maki’s Meta-Analysis)

• Position conflicts with CDC HICPAC Guideline, which addresses hemodialysis CVCs

• Transparent Dressings are safe for Hemodialysis CVCs

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Question One:

What is your recommendation on

shaving the skin before inserting a device?

Question Two:

What about the use of transparent dressings on

pediatric patients with Cystic Fibrosis?

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Question Three:

For short term central lines, are the risks of occlusion/stenosis

greater in the subclavian or jugular vein?

Question Four:

Is there any evidence-based data that supports the reduced

risk of infection with BIOPATCH® Antimicrobial

Dressing on PICC lines specfically?

Question Five:

Is there any published studies that provide numbers to

validate the use of BIOPATCH® Dressing in

Home Health?

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Are there enough evidence-based pediatric

studies to be able to make practice changes?

Question Six:

Question Seven:

If there is not excessive drainage, is it safe to apply the BIOPATCH®

Dressing immediately after insertion and leave the

transparent dressing in place for seven days (and not change it

after 24 hours as in our previous protocol)?

Question Eight:

In the NICU, what is the best dressing change protocol (what about BIOPATCH®Dressing and CHG Prep)?

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Question Nine:

With patients with impaired skin, we create a frame out of a hydrocolloid (DuoDERM®Dressing) and then place a

transparent dressing over it to immobilize the catheter. What

are your thoughts?

Question Ten:

How many people in this audience are using BIOPATCH®

Dressings?

Question Eleven:

Are there any studies for home nursing care setting on PIV catheters left in for greater than 96 hours for antibiotic

use?

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Question Twelve:

Please comment on the following practice:

one of our physicians inserts PICC catheters into the

external jugular and calls it a PICC catheter.

Comment:

Surveillance of central lines infections should include ICU

and non-ICU data and PICC lines.