The Dover Silicone Solution Story

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The Dover Silicone Solution Story

• And how to use it to your advantage!

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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 Healthcares premise is that the Dover 100
  Silicone Foley Catheter will provide the patient
  with better results from a complication,
  function, and potentially, reduced UTIs than a
  latex or latex IC catheter.

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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.

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LATEX MATERIAL

• Latex allergy is human bodys 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.

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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 wont deteriorate over time.

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CYTOTOXICITY OF LATEX URINARY CATHETERSBritish
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.

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URETHRITIS

• Irritation and inflammation of a patients
  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.

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CATHETER-INDUCED URETHRITIS A COMPARISON
BETWEEN LATEX AND SILICONE CATHETERS IN A
PROSPECTIVE CLINICAL TRIALBritish 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.

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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.

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COMPARISON OF SILICONE AND LATEX CATHETERS IN
THE DEVELOPMENT OF URETHRAL STRICTURE AFTER
CARDIAC SURGERYBritish 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.

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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.

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ENCRUSTATION
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URETHRITIS ENCRUSTRATION
Irritation of Mucosa
Segregation of blood particles (as a pathologic
reaction to inflammation) into bladder
Adherence to rough sticky surfaces (Latex)
High Risk
Low risk
Silikon
Latex
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WHICH INDWELLING URETHRAL CATHETERS RESIST
ENCRUSTATION BY PROTEUS MIRABILIS
BIOFILMSBritish 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)

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ENCRUSTATION OF INDWELLING URETHRAL CATHETERS BY
PROTEUS MIRABILIS BIOFILMS GROWING IN HUMAN
URINEJournal 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.

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

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CLINICAL APPLICATIONOF THE BARDEX IC FOLEY
CATHETEREuropean Urology 1999First 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 dont 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.

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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

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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.

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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.

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Silicone Solution Summary

• Silicone is non-toxic and eliminates latex
  allergies in patients
• Reduces urethritis or inflammation
• Reduces urethral stricture
• Reduces encrustation
• Reduces UTI

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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. Bards Latex catheter and the
  Bardex IC.