ExCel Presentation with audio

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Aplicare ExCelAP 7.5 Povidone-Iodine 72
Isopropyl Alcohol
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Agenda

• Background
• Advantages of
• Safety testing
• Efficacy testing in vitro
• Efficacy testing in vivo
• Conclusions

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Background

• ExCelAP
• Developed by Aplicare
• Combination of two well known/accepted
  antiseptics
• 7.5 PVP-I broad spectrum, persistent
• 72 IPA fast acting, broad spectrum
• Alcohol
• Dehydrates cells disrupts cell walls
• Denatures proteins leading to loss of function
• Not persistent
• Iodine
• Oxidizes organic material
• Attacks DNA, inhibits protein synthesis

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Background

• ExCelAP
• Combination of two well known/accepted
  antiseptics
• 7.5 PVP-I broad spectrum, persistent
• 72 IPA fast acting, broad spectrum
• Faster acting than PVP-I alone and more
  persistent than alcohol alone
• Best of both worlds
• Comparable or better efficacy when compared to
  ChloraPrep
• Data ???

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Advantages

• ExCelAP
• One vs. two step application
• No order of use confusion
• Faster drying time (alcohol)
• Area prepped clearly identified
• Film forming acrylate ingredient thickens formula
  which upon drying
• Facilitates application and decreases run off
• Sustains exposure of skin to iodine
• Improves adherence of transparent dressings
• Resists removal by water or bodily fluids
• Easy removal with soap and water
• Comparable or better efficacy when compared to
  ChloraPrep less irritating

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Safety

• Dermal Irritation on Rabbits
• ExCelAP not a primary dermal irritant
• Acute Oral Toxicity on Rats
• ExCelAP not orally toxic
• 21-Day Cumulative Skin Irritation on Humans
• Definitive FDA test for repeated use products
• Skin irritation potential within acceptable FDA
  limits
• See p. 3 of Technical Bulletin

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Safety

• 21-Day Cumulative Skin Irritation on Humans
• Definitive FDA test for repeated use products
• Skin irritation potential within acceptable FDA
  limits

Subjects withdrew
See handout
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Efficacy in vitro

• Time Kill of 10 Microorganism Strains
• ExCelAP highly effective vs. strains tested
• ExCelAP not affected by EtO sterilization
• See p. 4 - 5 of Technical Bulletin
• Time Kill and MIC (50 strains)
• ExCelAP effective vs. TFM specified
  microorganisms
• See p. 6 - 7 of Technical Bulletin

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Efficacy in vivo (human)

• Patient Preoperative, Precatheter / Catheter
  Maintenance, Preinjection Skin Preparation
• Patient Preop Skin Prep TFM requirements
• gt3 log10 reduction on inguinal sites within 10
  minutes not to exceed baseline after 6 hours
• gt2 log10 reduction on abdominal sites within 10
  minutes not to exceed baseline after 6 hours
• Patient Preinjection TFM requirements
• gt1 log10 reduction on median cubital sites within
  30 seconds
• Catheter Maintenance TFM requirements
• None defined

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Efficacy in vivo (human)

• Comparison of ExCelAP to its vehicle, 10 PVP-I,
  and ChloraPrep as a Patient Preoperative,
  Precatheter/ Catheter site Maintenance, and
  Preinjection Skin Preparation
• ExCelAP met TFM requirements as patient
  preoperative and preinjection skin prep
• Not significantly less effectively than
  ChloraPrep
• ChloraPrep failed to meet the TFM requirement for
  patient preoperative skin preps of at least a 3
  log10 reduction in the groin immediately after
  application
• See p. 8 - 11 of Technical Bulletin

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Efficacy in vivo (human)

• Comparison of ExCelAP to its vehicle, 10 PVP-I,
  and ChloraPrep as a Patient Preoperative,
  Precatheter/ Catheter site Maintenance, and
  Preinjection Skin Preparation
• ExCelAP significantly superior to ChloraPrep
  immediately after product application in the
  groin
• Suggests ExCelAP s superiority as a faster
  acting antiseptic
• See p. 10 of Technical Bulletin

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Efficacy in vivo (human)

• Comparison of ExCelAP to its vehicle, 10 PVP-I,
  and ChloraPrep as a Patient Preoperative,
  Precatheter/ Catheter site Maintenance, and
  Preinjection Skin Preparation
• ExCelAP met TFM requirements as patient
  preinjection skin prep with only a 10 second
  product application time
• ChloraPrep directions call for a 30 second
  product application time
• See p. 11 of Technical Bulletin

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Efficacy in vivo (human)

• Comparison of two application methods of ExCelAP
  with ChloraPrep as a Patient Preinjection Skin
  Preparation
• ExCelAP applied for 10 seconds and 30 seconds
  and ChloraPrep applied for 30 seconds can be
  considered effective patient preinjection skin
  preparations
• ExCelAP applied for 10 seconds performed equally
  to ChloraPrep applied for 30 seconds
• See p. 16 of Technical Bulletin

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Conclusions

• ExCelAP
• One vs. two step application
• No order of use confusion
• Faster drying time (alcohol)
• Area prepped clearly identified
• Film forming acrylate ingredient thickens formula
  which upon drying
• Facilitates application and decreases run off
• Sustains exposure of skin to iodine
• Improves adherence of transparent dressings
• Resists removal by water or bodily fluids
• Easy removal with soap and water
• Comparable or better efficacy when compared to
  ChloraPrep less irritating