The Dover The Dover Silicone Solution Silicone Solution

StoryStory

And how to use it to your advantage!

History Silicone material has been used in a number

of medical devices for past 30+ years. A number of studies have been completed

showing superior results of silicone foley catheters vs. latex foley catheters.

Tyco Healthcare’s premise is that the Dover 100% Silicone Foley Catheter will provide the patient with better results from a complication, function, and potentially, reduced UTI’s than a latex or latex IC catheter.

LATEX MATERIAL Natural rubber latex is a substance produced

by a rubber tree. It is organic and porous.– Composed of polyisoprene rubber, water,

and low levels of different proteins. As latex is manufactured into products,

chemicals are added to improve its properties. Manufacturers attempt to remove these during a leaching process, but some remain in product.– Chemicals in latex are toxic and can

cause skin irritation, rash and an allergic reaction.

LATEX MATERIAL Latex allergy is human body’s response to

proteins and chemicals in latex.• Type I: immediate reaction to

proteins• Type IV: delayed reaction to

chemicals Immune system reacts to allergens. Latex is inexpensive and easy to

manufacture by utilizing a dipping process. Material tends to deteriorate over time.

SILICONE MATERIAL Silicone material is non-toxic, inert, with no active

properties.– Man-made material from organic and inorganic

substances.

Silicone holds it shape and does not expand when in contact with water or urine.– This leads to less trauma upon removal

Silicone is strong and walls of silicone catheters can be manufactured with a smaller width, improving urine flow rate.– This will reduce the incidence of encrustation.

Manufactured by extrusion, easier to hold its french size.– Material won’t deteriorate over time.

“CYTOTOXICITY OF LATEX URINARY CATHETERS”

British Journal of Urology - 1985

“The full silicone catheters were non-toxic…..:” “…. there is now considerable evidence of the

cytotoxicity of latex catheters and all medical personnel should be aware that adverse urethral reactions . . . . . . .”

“This explains why the various labels “siliconized”, “coating contains silicone”, or “silicone treated” did not prevent against cytotoxicity . . . . . . .”

“Urologists should advise hospital staff to switch to silicone or plastic catheters despite their higher cost until better quality control of latex catheters has been established.”

URETHRITIS

Irritation and inflammation of a patient’s urethra following catheterization.

This condition can lead to urethral stricture or closing of urethra.

Can also lead to decreased urine flow. Latex causes more urethritis than

silicone.

“CATHETER-INDUCED URETHRITIS: A COMPARISON BETWEEN LATEX AND SILICONE

CATHETERS IN A PROSPECTIVE CLINICAL TRIAL”British Journal of Urology - 1985

“Of those with latex catheters 22% developed urethritis, compared with 2% of those in the silicone catheter group.”

“…. urethritis following short-term catheterization may be significantly reduced by the use of silicone catheters.”

“When one considers the problems of urethritis and stricture seen with latex catheters, the silicone catheters, despite their greater cost, should be considered cost effective and used for short-term catheterization.”

URETHRAL STRICTURE

Closing or narrowing of urethra. Can be caused by urethritis of urethra. Foley catheter is a common cause of

problem. Typically requires catheter or surgical

intervention.

“COMPARISON OF SILICONE AND LATEX CATHETERS IN THE DEVELOPMENT OF

URETHRAL STRICTURE AFTER CARDIAC SURGERY”

British Journal of Urology - 1986

Patients who had latex catheters had an incidence of urethral stricture of 5.2%.

Patients who had a silicone catheter had no incidence of urethral stricture.

“... we suggest that silicone catheters be used routinely for short-term catheterization in men undergoing cardiac bypass surgery.”

ENCRUSTATION

Mineral Salts in urine form on the outside, inside, and balloon of a Foley catheter

This can lead to urethritis and stricture. Encrustation may occur as bacterial cells,

such as Proteus mirabilis, adhere to catheter, which may lead to a UTI.

May require frequent catheter flushing and/or removal, requiring nursing time and supplies.

Patients experience pain upon catheter removal.

ENCRUSTATION

URETHRITIS & ENCRUSTRATION

Segregation of blood Segregation of blood particles (as a particles (as a pathologic reaction to pathologic reaction to inflammation) into inflammation) into bladder bladder

Adherence to ‚rough‘ & Adherence to ‚rough‘ & ‚sticky‘ surfaces (Latex)‚sticky‘ surfaces (Latex)

Irritation of MucosaIrritation of Mucosa

LateLatexx

SilikonSilikon

High High RiskRisk

Low riskLow risk

“WHICH INDWELLING URETHRAL CATHETERS RESIST ENCRUSTATION BY PROTEUS MIRABILIS

BIOFILMS”British Journal of Urology - 1997

“The mean times to blockage ranged from 21 h for the Bard hydrogel/silver-coated latex catheter to 56 h for the Eschmann Folatex S all-silicone catheter.”

“Kunin et al …..concluded that the encrustation and blockage was significantly less with silicone catheters than with teflon-coated or latex catheters.”

“The internal diameter is thus not surprisingly a major factor in determining time to blockage.”

“Silver is a potent antibacterial agent but failed to block colonization by a mineralizing bacterial biofilm.” (Hydrogel/Silver-coated Latex Bard)

“ENCRUSTATION OF INDWELLING URETHRAL CATHETERS BY PROTEUS MIRABILIS BIOFILMS

GROWING IN HUMAN URINE”Journal of Hospital Infection - 1998

“... the mean times to blockage ranging from 17.7 h (silver coated latex), 34 h (hydrogel-coated latex), 38 h (silicone coated latex) to 47 h (all silicone).”

“The internal diameters of the latex catheters were only 1.5 mm compared to the 2.5 mm of the all-silicone catheters.”

“It was not possible to conclude, however, that the silicone catheters were more resistant to encrustation, as it could well have been that their much larger central channels just took longer to block.”

“RANDOMIZED MULTI-CENTRE TRIAL OF THE EFFECTS OF A CATHETER COATED WITH HYDROGEL AND SILVER SALTS ON THE INCIDENCE OF HOSPITAL-ACQUIRED

URINARY TRACT INFECTONS”Journal of Hospital Infection - 2000

Compared 100% Silicone Foley catheter to a latex coated infection control catheter.

No difference in infection rates after 10 days of use. Total of 199 patients.

Conclusion:– “Overall, we feel that there is not enough evidence to

conclude that catheters coated with silver salts and hydrogel give greater protection than classical catheters and to recommend widespread use.”

– Study (only two available), comparing standard 100% silicone foley catheters to latex IC foley catheters, showing no advantage to an IC coating on a latex catheter vs. 100% silicone material alone.

“CLINICAL APPLICATIONOF THE BARDEX IC FOLEY CATHETER”

European Urology – 1999*First Trial Discussed In Article

“In the first trial,…. 18 patients with the Bardex IC catheter were compared to 17 patients with a silicone catheter after the same procedure. There was no significant difference in bacteriuria after 14 days (50.0 vs. 53.3%).”

They don’t provide details on infection rates earlier than 14 days, but we can assume there were no major differences, or these would have been represented.

The larger, second trial switched to a latex vs. latex IC catheter. We can assume this was done to emphasize the difference in a better light.

CAUTI

(Catheter Associated Urinary Tract Infection) Rate

in Two Clinical Abstracts,(D.G. Maki, M.D.) Catheter

ROCM Release-NF® 100% Silicone Foley Catheter(IC)

ROCM Standard 100% Silicone Foley Catheter

Bard Latex IC Foley Catheter

Bard Standard Latex Foley Catheter

Infection Rate

5.3%

8.2%

15.4%

21.2%

Discussion Points

There are two separate clinical studies that were completed by Dr. Maki, et al at University of Wisconsin, using different catheters but a similar clinical protocol.

In Bard Study “A Novel Silver-Hydrogel-Impregnated . . . . Double Blind Trial” compares a Bard Latex IC Foley to a Bard Standard Latex Foley (non-IC). Infection rates are seen on previous slide are stated in the abstract.

Discussion Points In Rochester Medical study, “A Prospective . . . . .

Indwelling Urinary Catheter”, the same researchers compared a Rochester Medical (ROCM) 100% Silicone uncoated catheter to a Rochester Nitrofurazone-impregnated infection control catheter (non-IC). Infection rates for this trial studied 344 patients (14 infections in 170 catheters – all silicone vs. 9 infections out of 174 patients-Release NF) to calculate the infection rate.

An objective look at these two studies indicates that 100% silicone catheter material by itself may provide the greater or equal benefit in reducing CAUTI than an IC coating on a Latex Foley Catheter. Comparing the two studies, the Std. Silicone Foley had an infection rate of 8.2% vs. the Bard Latex IC Catheter which had a 15.4% infection rate.

“Silicone Solution” Summary

Silicone is non-toxic and eliminates latex allergies in patients

Reduces urethritis or inflammation Reduces urethral stricture Reduces encrustation Reduces UTI

“Silicone Solution” Summary

Better flow rate and drainage vs. latex Reduced incidence of non-deflators Dr. Maki Abstracts, Belgium Study, and

the Bard Labeling Claim Change all add up to the advantage of Silicone vs. Bard’s Latex catheter and the Bardex IC.