1. A 9 YearA 9 Year Clinical Experience with Kelo-coteClinical Experience with Kelo-cote ®®
The Role of Topical Silicone In Wound HealingThe Role of Topical Silicone In Wound Healing
Rex Moulton-Barrett, MDRex Moulton-Barrett, MD
Plastic and Reconstructive SurgeryPlastic and Reconstructive Surgery
Oakland, CaliforniaOakland, California

2. Not all wounds are created equallyNot all wounds are created equally
• Fresh surgical: sharp edges, tensionless epidermis, layered dermal repairFresh surgical: sharp edges, tensionless epidermis, layered dermal repair
• Traumatized tissue: crushed irregular edges, tensionTraumatized tissue: crushed irregular edges, tension
• Thermal and chemical burns: basal layer and dermis may be absentThermal and chemical burns: basal layer and dermis may be absent
• Post-scar ( hypertrophic/keloid ) excision: tendency to recurPost-scar ( hypertrophic/keloid ) excision: tendency to recur
• Scar prone locations: chin to xiphoid, intra-mucosalScar prone locations: chin to xiphoid, intra-mucosal
• Scar prone races: related to Fitzpatrick skin types: tan easily=scar easilyScar prone races: related to Fitzpatrick skin types: tan easily=scar easily
Epidermis: 40 - 150 microns
Dermis: 140 - 400 microns
E & D: 180 >/= 550 microns

3. Choices In Topical TherapyChoices In Topical Therapy
Dry WoundsDry Wounds
• TapesTapes: control tension, shear through surface protection, hydration: control tension, shear through surface protection, hydration
• Oil based antibiotic ointmentsOil based antibiotic ointments: Polymyxin, Bacitracin, Bactroban,: Polymyxin, Bacitracin, Bactroban,
NeosporinNeosporin
• Skin substitutesSkin substitutes: Biobrane, Alloderm: Biobrane, Alloderm
• Silicone gel:Silicone gel: Kelo-cote, Scarfade, MedermaKelo-cote, Scarfade, Mederma
• Silicone gel sheetingSilicone gel sheeting : Cica-care, Epiform, Mepilex,: Cica-care, Epiform, Mepilex,
Mepitel, SilgelMepitel, Silgel
• Collagens: Clayton ChagallCollagens: Clayton Chagall
• Tissue adhesivesTissue adhesives: cyanoacrylate-Dermabond, Epiglu, Indemil,: cyanoacrylate-Dermabond, Epiglu, Indemil,
LiquibandLiquiband
• Barrier filmsBarrier films: fast drying carrier solvent: Cavillon, Comfeel,: fast drying carrier solvent: Cavillon, Comfeel,
SuperskinSuperskin

4. Choices In Topical TherapyChoices In Topical Therapy
Wet WoundsWet Wounds
• Silver dressingsSilver dressings: Acticoat, Actisorb, Avance, Flamazine: Acticoat, Actisorb, Avance, Flamazine
• FoamsFoams: absorptive for exudates-Allevyn, Flexipore: absorptive for exudates-Allevyn, Flexipore
• AlginatesAlginates: seaweed based very absorptive- Meligisorb, Algisite, Sorbsan: seaweed based very absorptive- Meligisorb, Algisite, Sorbsan
• HydrogelsHydrogels: >70% water,minimally absorptive- Aquaform, Intrasite, Nu-Gel: >70% water,minimally absorptive- Aquaform, Intrasite, Nu-Gel
• HydrocolloidsHydrocolloids: semi-permaeable-Aquacel, Cutinova: semi-permaeable-Aquacel, Cutinova
• Vapour permaeable filmsVapour permaeable films: semi-permeable, fluid accululates-Tegaderm: semi-permeable, fluid accululates-Tegaderm
• Low-Adherance DressingsLow-Adherance Dressings: Telfa, Medipore, Cutilin, Xeroform: Telfa, Medipore, Cutilin, Xeroform
• Multi-layer bandagesMulti-layer bandages: useful for venous ulceration- Profore: useful for venous ulceration- Profore

5. Components of Normal Wound HealingComponents of Normal Wound Healing
•CoagulationCoagulation
processprocess
•InflammatoryInflammatory
processprocess
•Migratory/Migratory/
ProliferativeProliferative
processprocess
•RemodelingRemodeling
processprocess
Injury: hours / days weeks
A) Immediate to 2-5 days
B) Hemostasis : Vasoconstriction , Platelet
aggregation , Thromboplastin clot
C) Inflammation: Vasodilation , Phagocytosis
A) 2 days to 3 weeks
B) Granulation: Fibroblasts lay collagen, Fills & new capillaries
C) Contraction: Wound edges pull together to reduce defect
D) Epithelialization: Crosses moist surface up to 3 cm
A) 3 weeks to 2 years
B) New collagen forms which increases tensile strength
C) Scar tissue is only 80 percent as strong as original tissue

6. Biochemical DifferencesBiochemical Differences
HealingHealing woundswounds ChronicChronic woundswounds
• cell mitosiscell mitosis
• pro-inflammatory cytokinespro-inflammatory cytokines
• matrix metalloproteinasesmatrix metalloproteinases
• growth factorsgrowth factors
• cells capable of respondingcells capable of responding
to healing signalsto healing signals

7. TIMETIME Principles of Wound Bed PreparationPrinciples of Wound Bed Preparation
Wound bed preparation accelerates healingWound bed preparation accelerates healing
Tissue non
viable or
deficient
Infection or
inflammation
Moisture
imbalance
Edge of wound
non advancing
or undermined
Defective
matrix and cell
debris
High bacterial
counts or
prolonged
inflammation
Desiccation
or excess
fluid
Non-migrating
keratinocytes
Non-responsive
wound cells
Debridement Antimicrobials Dressings
compression
Biological agents
Adjunct Therapies
Debridement
Restore wound
base and ECM
proteins
Low bacterial
counts and
controlled
inflammation
Restore cell
migration,
maceration
avoided
Stimulate
keratinocyte
migration

8. Debridement MethodsDebridement Methods
• Surgical: exciseSurgical: excise
• Mechanical: adherence, sheer, irrigateMechanical: adherence, sheer, irrigate
• Autolytic: topicalAutolytic: topical
• Enzymatic: topicalEnzymatic: topical
• Biological: topicalBiological: topical

9. Autolytic DebridementAutolytic Debridement
•The process by which the woundThe process by which the wound
bed utilizes phagocytic cells andbed utilizes phagocytic cells and
proteolytic enzymes to removeproteolytic enzymes to remove
debrisdebris
•This process can be promotedThis process can be promoted
and enhanced by maintaining aand enhanced by maintaining a
moist wound environmentmoist wound environment

10. Autolytic Debridement ConsiderationsAutolytic Debridement Considerations
• Less aggressiveLess aggressive
• SlowerSlower
• Easy to performEasy to perform
• Little or no discomfortLittle or no discomfort
• Performed in any settingPerformed in any setting
• Contraindication: infectionContraindication: infection

11. Enzymatic DebridementEnzymatic Debridement
•The use of topically appliedThe use of topically applied
chemical agents to stimulate thechemical agents to stimulate the
breakdown of necrotic tissuebreakdown of necrotic tissue
•Common Topical AgentsCommon Topical Agents
– Papain-UreaPapain-Urea
– Papain-Urea-ChlorophyllinPapain-Urea-Chlorophyllin
– CollagenaseCollagenase

12. Enzymatic DebridementEnzymatic Debridement
Collagenase
• Derived from Clostridium Hystoliticum
• Highly specific for peptide sequence found
in collagen
• Less aggressive debridement
• Site of action – collagen fibers anchoring
necrotic tissue to the wound bed
10
Harper (1972) 11
Boxer (1969) 12
Varma (1973)

13. Enzymatic DebridementEnzymatic Debridement
Papain-UreaPapain-Urea
• Proteolytic enzyme derived papayaProteolytic enzyme derived papaya66
• Urea is added as a denaturantUrea is added as a denaturant66
• Site of action – cysteine residues on proteinSite of action – cysteine residues on protein88
6
Falabella (1998) 8
Sherry and Fletcher (1962)

14. Enzymatic Debridement ConsiderationsEnzymatic Debridement Considerations
• Should be painlessShould be painless
• Less traumatic thanLess traumatic than
surgical or mechanicalsurgical or mechanical
debridementdebridement
• Easy dressing changeEasy dressing change
• Observe caution withObserve caution with
infected woundsinfected wounds
*Agency for Healthcare Research and Quality (1994)
• Consider for individuals who:Consider for individuals who:
– Cannot tolerate surgeryCannot tolerate surgery
– long-term-care facilitylong-term-care facility
– home care*home care*

15. The right method is a clinical decision that requires judgment
Autolytic Collagenase Papain-Urea-Chlorophyllin

16. Bacterial BalanceBacterial Balance
• Intact skin is a physical barrierIntact skin is a physical barrier
• Skin secretes fatty acids and antibacterialSkin secretes fatty acids and antibacterial
polypeptidespolypeptides
• Normal flora prevent pathogenic floraNormal flora prevent pathogenic flora
from establishingfrom establishing

17. 13
Robson (1997) 14
Dow (2001)
Bacterial BurdenBacterial Burden
• Tissue bacterial levelsTissue bacterial levels > 10> 105/gram5/gram
havehave
consistently resulted in impaired healingconsistently resulted in impaired healing
causing:causing:
• Metabolic loadMetabolic load
• Produces endotoxins and proteasesProduces endotoxins and proteases

18. Efficacy of traditional topical antibioticsEfficacy of traditional topical antibiotics
• Leyden & Kligman, 1979Leyden & Kligman, 1979: Neomycin contact sensitivity < 1% skin testing: Neomycin contact sensitivity < 1% skin testing
• Booth, etal,1994Booth, etal,1994:: Minimum Inhibitory Concentration mg/LMinimum Inhibitory Concentration mg/L
Bacteria A:NeomycinBacteria A:Neomycin B:Bacitracin C:Polymyxin B (TAO): A+B+CB:Bacitracin C:Polymyxin B (TAO): A+B+C
Staph AureusStaph Aureus 11 5454 6161 synergysynergy
Pseudomonas aerug.Pseudomonas aerug. 3232 >6917>6917 88 synergysynergy
Enteric bacillus 8 >6917 1Enteric bacillus 8 >6917 1 synergysynergy
• Dire, et al, 1995Dire, et al, 1995: Uncomplicated sutured soft tissue trauma wounds: Uncomplicated sutured soft tissue trauma wounds
Topical Agent Infection RateTopical Agent Infection Rate
Bacitracin ZincBacitracin Zinc 5.5%5.5%
TAOTAO 4.5%4.5%
PetroleumPetroleum 17.6%17.6%

19. 33 ““RulesRules”” for Topical Antimicrobial Agents ?for Topical Antimicrobial Agents ?
• Do not useDo not use antibiotics that are usedantibiotics that are used systemicsystemically – ability toally – ability to
breed resistant organisms (topicalbreed resistant organisms (topical gentamicingentamicin, tobramycin), tobramycin)
• Do not useDo not use agents that are commonagents that are common allergensallergens (neomycin,(neomycin,
gentamicin, amikacin, tobramycin,gentamicin, amikacin, tobramycin, bacitracinbacitracin, lanolin), lanolin)
• Do not use agentsDo not use agents that have highthat have high cellular toxicitycellular toxicity in healablein healable
wounds (povidone iodine, chlorhexidine,wounds (povidone iodine, chlorhexidine, hydrogen peroxidehydrogen peroxide))
22
Sibbald 2003

20. Topical Antimicrobials:Topical Antimicrobials: SilverSilver
• Centuries of useCenturies of use
• Cytotoxicity associated with carriers not silver - ex.Cytotoxicity associated with carriers not silver - ex.
SilverSilver nitratenitrate, Silver, Silver sulfasulfadiazinediazine
• Traditional delivery required repeated applicationsTraditional delivery required repeated applications
due to binding with chlorine and proteinsdue to binding with chlorine and proteins
• New silver dressings allow for continued silverNew silver dressings allow for continued silver
release in to the dressing - up to 7 daysrelease in to the dressing - up to 7 days
17
Demling and DeSanti (2001)

21. Why Silver for Wound Bed Preparation?Why Silver for Wound Bed Preparation?
• Broad spectrum antimicrobial: yeasts, molds &Broad spectrum antimicrobial: yeasts, molds &
bacteria, including MRSAbacteria, including MRSA
• Kills microbes on contact: inhibition cellular respirationKills microbes on contact: inhibition cellular respiration
denatures nucleic acidsdenatures nucleic acids
alters cell membrane permeabilityalters cell membrane permeability
• Does not induce resistance: if used at adequate levelsDoes not induce resistance: if used at adequate levels
• Low mammalian cell toxicityLow mammalian cell toxicity

22. Nanocrystalline SilverNanocrystalline Silver
• Decreased size of silver particlesDecreased size of silver particles
leads to increased proportion ofleads to increased proportion of
surface atomssurface atoms
• The nanocrystalline structure isThe nanocrystalline structure is
responsible for the rapid and longresponsible for the rapid and long
lasting actionlasting action1515
17
Demling and DeSanti (2001)
Magnification of normal Silver
Magnification of Nanocrystalline Silver (< 1 micron)

23. Evaluating Silver ProductsEvaluating Silver Products
• Minimum bactericidal concentration (MBC)Minimum bactericidal concentration (MBC)
- amount of antimicrobial agent- amount of antimicrobial agent
required to kill a given microberequired to kill a given microbe
MBC is represented by a log reduction of 3MBC is represented by a log reduction of 3
Stratton et al (1991)Stratton et al (1991)
– The silver required varies from 5ppm - 50+ ppmThe silver required varies from 5ppm - 50+ ppm
for clinically relevant microbesfor clinically relevant microbes
Yin et al (1999) & Hall (1987)Yin et al (1999) & Hall (1987)
– MBC of silver for MRSA = 60.5 ppmMBC of silver for MRSA = 60.5 ppm
Calculated from Maple et al (1992)Calculated from Maple et al (1992)

24. Moist Wound EnvironmentMoist Wound Environment
Additional benefitsAdditional benefits
•Faster healingFaster healing
•Capacity for autolysisCapacity for autolysis
•Decreased rates of infectionDecreased rates of infection
•Reduced wound traumaReduced wound trauma
•Decreased painDecreased pain
•Fewer dressing changesFewer dressing changes
•Cost effectiveCost effective

25. • DifferentDifferent from acute woundfrom acute wound
• ImbalanceImbalance of growth factors andof growth factors and
pro-inflammatory cytokinespro-inflammatory cytokines
• Excessively high levels ofExcessively high levels of proteasesproteases
• DegradesDegrades ECM and selectivelyECM and selectively inhibitsinhibits proliferating cellsproliferating cells
21
Enoch and Harding, 2003
Exudate from a Chronic Wound

26. Managing Moisture ImbalanceManaging Moisture Imbalance
• FilmsFilms
• HydrogelHydrogel
• HydrocolloidHydrocolloid
• AlginateAlginate
• FoamsFoams
• Specialty AbsorbentSpecialty Absorbent
• Suction VacSuction Vac
• Exudate amountExudate amount
None Small Moderate Large

27. Suction Vac TherapySuction Vac Therapy
Management of open woundsManagement of open wounds
• increases granulation rate> 5xincreases granulation rate> 5x ’’ss
• success depends on pore size, -125mmHgsuccess depends on pore size, -125mmHg
• reduces wound volumereduces wound volume
• requires changing every 2 daysrequires changing every 2 days
• vascular ingrowth andvascular ingrowth and
healing appear to be due cell deformationhealing appear to be due cell deformation
• early epithelial cells lack rete pegs andearly epithelial cells lack rete pegs and
are easily strained to 5-20%,are easily strained to 5-20%,
postulated mechanismpostulated mechanism
Saxena, etal, 2004: PRS 114(5)Saxena, etal, 2004: PRS 114(5)

28. Modern Scar Concepts (1)Modern Scar Concepts (1)
• New keratinocytes lack rete pegs, are fragile, deformableNew keratinocytes lack rete pegs, are fragile, deformable
and produce many fibrotic growth factorsand produce many fibrotic growth factors
• Fibroblasts within the injury zone are more sensitive toFibroblasts within the injury zone are more sensitive to
these and other growth factorsthese and other growth factors
• Sulphated side chains develop from chondroitin producedSulphated side chains develop from chondroitin produced
from these fibroblastsfrom these fibroblasts
• The side chains cause water binding and subsequent scarThe side chains cause water binding and subsequent scar
rigidityrigidity

29. Modern Scar Concepts (2)Modern Scar Concepts (2)
CollagenesisCollagenesis - Deposition - Resorption- Deposition - Resorption
CollagenesisCollagenesis
• Scar volume is dependent on the volume of collagenScar volume is dependent on the volume of collagen
• Collagen formation: mRNA mediatedCollagen formation: mRNA mediated
• Fibroblast interferon ß( IFN- ß): inhibitor of collagenesisFibroblast interferon ß( IFN- ß): inhibitor of collagenesis
• Transforming Growth Factor TGF ß 1 (adult): stimulates collagenesisTransforming Growth Factor TGF ß 1 (adult): stimulates collagenesis
• TGF ß 3 (infant): inhibits collagenesisTGF ß 3 (infant): inhibits collagenesis
• Renovo/ Retinae: inhibitors of TGF- ß1 activation: reduced collagenesisRenovo/ Retinae: inhibitors of TGF- ß1 activation: reduced collagenesis
improving scarsimproving scars
• Gamma interferons and other cytokines down regulate collagen andGamma interferons and other cytokines down regulate collagen and
matrix synthesis and increase monocyte retention within the woundmatrix synthesis and increase monocyte retention within the wound

30. Modern Scar Concepts (3)Modern Scar Concepts (3)
Collagenesis -Collagenesis - Deposition -Deposition -
ResorptionResorption
Collagen Deposition & ResorptionCollagen Deposition & Resorption
• Fibroblast and monocyte collagenase:Fibroblast and monocyte collagenase: reduce collagen depositionreduce collagen deposition
• MetalloproteinasesMetalloproteinases inhibit collagenasesinhibit collagenases: promoting collagen deposition: promoting collagen deposition
• Expression of fetal metalloproteinase: loss of scarless healingExpression of fetal metalloproteinase: loss of scarless healing
• Intralesional steroids inhibit fibroblast growthIntralesional steroids inhibit fibroblast growth
inhibit collagen deposition:inhibit collagen deposition:
-- increaseincrease monocytemonocyte collagenasecollagenase secretionsecretion
- no influence on metalloproteinase- no influence on metalloproteinase
- no influence on collagen production- no influence on collagen production

31. Modern Scar Concepts (4)Modern Scar Concepts (4)
++ The Role of Tissue HypoxemiaThe Role of Tissue Hypoxemia --
• -- impedes epithelialisationimpedes epithelialisation
• -- increases infection: neutrophil dependentincreases infection: neutrophil dependent
• + reduces collagenesis in an epithelialised wound+ reduces collagenesis in an epithelialised wound
• + compression and radiation lead to local fibroblastic+ compression and radiation lead to local fibroblastic
hypoxemiahypoxemia
• : Compression and radiation should be used: Compression and radiation should be used afterafter
epithelialisation is completeepithelialisation is complete

38. Summary of Treatments for Hypertrophic Scar andSummary of Treatments for Hypertrophic Scar and
KeloidsKeloids
• SurgerySurgery
• Laser ExcisionLaser Excision
• Pulse Dye Laser ReductionPulse Dye Laser Reduction
• CryotherapyCryotherapy
• Pressure TherapyPressure Therapy
• RadiotherapyRadiotherapy
• Steroid, Interferon, 5-FU Injections, ColchicineSteroid, Interferon, 5-FU Injections, Colchicine
• Topical Aldara 5%Topical Aldara 5%
• Prolonged tapingProlonged taping**
• Silicone gel/sheetingSilicone gel/sheeting** ** patient controlledpatient controlled
inexpensiveinexpensive
non-prescriptionnon-prescription
few if any complicationsfew if any complications
well toleratedwell tolerated

39. Prolonged Paper Tape To ScarProlonged Paper Tape To Scar
• 70 pts acute scars: s/p caesarian section, Brisbane, Australia70 pts acute scars: s/p caesarian section, Brisbane, Australia
• Micropore tape to randomized 1/2 pts after staple removal 4-7 days post-opMicropore tape to randomized 1/2 pts after staple removal 4-7 days post-op
• Tape applied continuously for 12 weeksTape applied continuously for 12 weeks
• The control group received no treatmentThe control group received no treatment
• Scar volume was assessed by ultrasoundScar volume was assessed by ultrasound
• Scar volume was reduced in the treatment group (p<0.05)Scar volume was reduced in the treatment group (p<0.05)
• High correlation between subjective scar rating & intradermal scarringHigh correlation between subjective scar rating & intradermal scarring
( p<0.001)( p<0.001)
• Authors postulate that tension is the cause of significant scarringAuthors postulate that tension is the cause of significant scarring
Atkinson,et al, PRS Nov 2005; 116 (6), 1648-Atkinson,et al, PRS Nov 2005; 116 (6), 1648-

40. Management of Common KeloidsManagement of Common Keloids
• Earlobe - If primary excision:Earlobe - If primary excision:
3 x daily peroxide and triple antibiotic3 x daily peroxide and triple antibiotic
remove nylon 5.0 sutures at 10-14 days, then:remove nylon 5.0 sutures at 10-14 days, then:
Dermajet inject Kenalog (trimacinolone 40mg/ml)Dermajet inject Kenalog (trimacinolone 40mg/ml)
start Kelo-cote after sutures out for at least 3 monthsstart Kelo-cote after sutures out for at least 3 months
start compressive clampstart compressive clamp ““ear-ringear-ring”” : no Nickel: no Nickel
return every 6 weeks for further injectionsreturn every 6 weeks for further injections
• Berman B, Bieley HC. Dermatol Surg 1996 Feb;22(2):126-30
– excision alone: 45-100 % recurrence
– excision and Kenalog injection: < 50 % recurrence
– excision and irradiation: < 10% recurrence
– excision and button compression: no recurrences

41. www.delasco.comwww.delasco.com tel: 1 800 320-9612tel: 1 800 320-9612

42. Management of Common KeloidsManagement of Common Keloids
• Earlobe - if secondary excision:Earlobe - if secondary excision:
excise and within 14 days: post-op irradiationexcise and within 14 days: post-op irradiation
either one dose of 10 Gy or up to 15 Gy in 2-4 fractionseither one dose of 10 Gy or up to 15 Gy in 2-4 fractions
sutures out 14 days post-opsutures out 14 days post-op
Kenalog injection, compressive ear-ring and 6 week follow-upKenalog injection, compressive ear-ring and 6 week follow-up
Klumpar DI, Murray JC, Anscher M. J Am Acad Dermatol 1994 Aug;31(2 Pt 1):225-31
- Dose irradiation most important factor: give >900c Gy- Dose irradiation most important factor: give >900c Gy
- Irradiation completed within 1-3 weeks equally effective- Irradiation completed within 1-3 weeks equally effective
- ear lobe 98% successful at > 1 yr follow-up- ear lobe 98% successful at > 1 yr follow-up
- small subsequent recurrences can be re-irradiated: 15 Gy- small subsequent recurrences can be re-irradiated: 15 Gy

43. Improvement of Erythematous and Hypertrophic Scars by heImprovement of Erythematous and Hypertrophic Scars by he
585-nm Flashlamp-pumped Pulsed Dye Laser,585-nm Flashlamp-pumped Pulsed Dye Laser, Tina Alster.Tina Alster.
Ann Plast Surg 1994;32:186-190Ann Plast Surg 1994;32:186-190
• 14 healthy subjects with hypertrophic and or erythematous scars as a results14 healthy subjects with hypertrophic and or erythematous scars as a results
of traumaof trauma
• Scars were at least 2 years oldScars were at least 2 years old
• Candela flashlamp-pumped dye laser: 6.5-6.75 J/cm2 1-2 treatmentsCandela flashlamp-pumped dye laser: 6.5-6.75 J/cm2 1-2 treatments
• 57% improved: lightening and flatter after one treatment57% improved: lightening and flatter after one treatment
• 83% improved after 2 treatments83% improved after 2 treatments
• Continued improvement over 6 monthsContinued improvement over 6 months
• Improvement was not location specific,Improvement was not location specific, depth of scar not assesseddepth of scar not assessed

44. Irradiation mostly contraindicatedIrradiation mostly contraindicated
Re-resection definitely harmfulRe-resection definitely harmful
Laser excision usually harmfulLaser excision usually harmful
Pulse Dye lasers not helpfulPulse Dye lasers not helpful
Aldara 5% not helpfulAldara 5% not helpful
Silicone sheeting not helpfulSilicone sheeting not helpful
Steroid injections very helpfulSteroid injections very helpful
Kelo-cote helpful if < 5mm raisedKelo-cote helpful if < 5mm raised

45. Kelo-cote® unique formulationKelo-cote® unique formulation
• Kelo-cote® composition:Kelo-cote® composition:
– Long chain polymers of siliconeLong chain polymers of silicone
(Polysiloxanes)(Polysiloxanes)
– Minimal Silicone dixoide cross links polymersMinimal Silicone dixoide cross links polymers
– A volatile solvent allows silicone to dry on theA volatile solvent allows silicone to dry on the
stratum corneum in an ultra-thin sheetstratum corneum in an ultra-thin sheet

46. Silicone CompositionSilicone Composition
Silanes: monomers
R Characteristics
Methyl Hydrophobicity & Low surface tension
Higher Alkyl Organic-compatibility and Paintability
Phenyl Thermo-stabile,Organo-compatible,
Hydrophobic CF3CH2CH2 Solvent resistant
Siloxanes: polymers
more crosslinked: more solid
recurring silicone / oxygen backbone
end / side chains determine functionality
ie.: amine,carboxy, hydroxyl,epoxyl
RR
RR
R:R:

47. Favorable properties related to scar reductionFavorable properties related to scar reduction
• Intermediate forms: elastomers: gel, rubberIntermediate forms: elastomers: gel, rubber
• Solid-liquid binding requires catalystSolid-liquid binding requires catalyst ‘‘curingcuring’’: ie. platinum,: ie. platinum,
stannous octoatestannous octoate
• Delivery in an evaporative solvent may provide the ability to changeDelivery in an evaporative solvent may provide the ability to change
the properties of the silicone upon deliverythe properties of the silicone upon delivery
• Properties influencing scar reduction include:Properties influencing scar reduction include:
– Thickness:Thickness: < 0.254mm< 0.254mm
– Moisture vapor transmission rate:Moisture vapor transmission rate: <15mg/cm2/day<15mg/cm2/day
– Oxygen permeability:Oxygen permeability: > 600cc/100 in.sup.2/day> 600cc/100 in.sup.2/day
– High stretch:High stretch: ,1.5lbs/in stretches > 110% length,1.5lbs/in stretches > 110% length
– Tensile strength:Tensile strength: >100g>100g
– Penetrability:Penetrability: 4-7mm4-7mm
– Peel strength:Peel strength: 2-6 g2-6 g

48. Silicone Mode of ActionSilicone Mode of Action
• Potential TheoriesPotential Theories
– Hydration: increasesHydration: increases
– Oxygenation: decreasesOxygenation: decreases
– Protection: increasesProtection: increases
– Cellular Strain: increases ?Cellular Strain: increases ?
– Modulation of growth factorsModulation of growth factors

49. Silicone Mode of ActionSilicone Mode of Action
HydrationHydration
• Kelo-cote is semi-occlusive aerating and hydratingKelo-cote is semi-occlusive aerating and hydrating
• Silicone absorption is limited to the epidermisSilicone absorption is limited to the epidermis
• Stratum corneum regulates fibroblast /collagenesisStratum corneum regulates fibroblast /collagenesis
• Hydration normalises the collagen synthesisHydration normalises the collagen synthesis

50. Silicone Mode of ActionSilicone Mode of Action
HydrationHydration
• But not all breathable dressings will reduce scarsBut not all breathable dressings will reduce scars
• In a study comparing silicone and hydrogel dressings,In a study comparing silicone and hydrogel dressings,
silicone normalised collagen synthesis,silicone normalised collagen synthesis,
other breathable non-silicone dressings did notother breathable non-silicone dressings did not
• Silicone has a scar reducing characteristic not seen withSilicone has a scar reducing characteristic not seen with
polyurethanespolyurethanes
• Further research ongoingFurther research ongoing

51. Silicone Mode of ActionSilicone Mode of Action
ProtectionProtection
• Microbial, chemical or physical irritation promote excessive collagenMicrobial, chemical or physical irritation promote excessive collagen
production in early scars:production in early scars:
• Keratinocyte dependent: exposed cell release growth factorsKeratinocyte dependent: exposed cell release growth factors
• Fibroblast dependent: Staph epidermidis Immortalization TheoryFibroblast dependent: Staph epidermidis Immortalization Theory
• Intact dermis is necessary for normal wound healingIntact dermis is necessary for normal wound healing

52. Silicone Mode of ActionSilicone Mode of Action
Modulation TheoryModulation Theory
• Silicones oils and sheeting appear to have an influence onSilicones oils and sheeting appear to have an influence on
Fibroblast growth factors and transforming growth factorsFibroblast growth factors and transforming growth factors
• Silicone reduces FGFSilicone reduces FGF growth factors in vivo, yetgrowth factors in vivo, yet
( opposite in vitro )( opposite in vitro )
– Fibroblast are reducedFibroblast are reduced
– Collagenase is increasedCollagenase is increased
• ““Collagen production is normalisedCollagen production is normalised””

53. History of Silicone in Scar ReductionHistory of Silicone in Scar Reduction
• Perkins et al, 1983Perkins et al, 1983: reported silicone a new treatment for hypertrophic scars: reported silicone a new treatment for hypertrophic scars
• Ahn, et al, 1989Ahn, et al, 1989: silicone gel improved texture, color, thickness and: silicone gel improved texture, color, thickness and
itching from small hypertrophic scarsitching from small hypertrophic scars
• Sawada & Sone, 1990Sawada & Sone, 1990: 20% silicone gel 82% improved hypertrophic: 20% silicone gel 82% improved hypertrophic
scars and keloids a.c.t. glycerin 22% improvedscars and keloids a.c.t. glycerin 22% improved
• Sawada &Sone, 1992Sawada &Sone, 1992: silicone gel an elastomer sheeting vs. petroleum,: silicone gel an elastomer sheeting vs. petroleum,
6 months f/u silicone group much softer, less red6 months f/u silicone group much softer, less red
• Pamieri, et al, 1995Pamieri, et al, 1995: Found Vit E enhanced hypertrophic scar and keloids: Found Vit E enhanced hypertrophic scar and keloids
• Phillips, et al. 1996Phillips, et al. 1996: hydrocolloid dressings no evidence to support reduce: hydrocolloid dressings no evidence to support reduce
scarring after hypertrophic scar or keloid establishedscarring after hypertrophic scar or keloid established
Good review: Mustoe, et al, PRS 2002:110(2) 560-Good review: Mustoe, et al, PRS 2002:110(2) 560-
Literature lacks double blind placebo controlled studiesLiterature lacks double blind placebo controlled studies

54. Placebo Controlled Pilot Study Evaluating Kelo-cotePlacebo Controlled Pilot Study Evaluating Kelo-cote
in the Reduction of Scarring Following Cleft Lip Repairin the Reduction of Scarring Following Cleft Lip Repair
10 days post-op10 days post-op 8 weeks post-op8 weeks post-op 8 months post-op8 months post-op
• 33 patients, Santiago, Chile, 199633 patients, Santiago, Chile, 1996
• Methods: mm vertical scar shortening (A-Methods: mm vertical scar shortening (A-
B)B)
mm depth lip notchmm depth lip notch
*average width scar mm*average width scar mm
scar softness 0-3 gradescar softness 0-3 grade
scar erythema 0-3 gradescar erythema 0-3 grade
• 6 week follow-up results6 week follow-up results
**
AA BB

55. Markedly reduced erythema (p< 0.005)Markedly reduced erythema (p< 0.005)
Reduced horizontal scar width ( p<0.05)Reduced horizontal scar width ( p<0.05)

56. Chan, et al, 2005: PRS Sept 15Chan, et al, 2005: PRS Sept 15
• Placebo controlled study prospective clinical trialPlacebo controlled study prospective clinical trial
of silicone gel ( Scarfadeof silicone gel ( Scarfade ®®) in the prevention of) in the prevention of
hypertrophic median sternotomy scarshypertrophic median sternotomy scars
– 100 wounds/50 pts Malaysia100 wounds/50 pts Malaysia
– Reduction of:Reduction of: pigmentation (p=0.02)pigmentation (p=0.02)
vascularity (p=0.001)vascularity (p=0.001)
pliability (p=0.001)pliability (p=0.001)
height (p=0.001)height (p=0.001)
pain (p=0.001)pain (p=0.001)
itchiness (p=0.001)itchiness (p=0.001)

57. Sebastian et al, 2005Sebastian et al, 2005
•• Non-placebo controlled study Kelo-cote on scars: all-comers, up to 48Non-placebo controlled study Kelo-cote on scars: all-comers, up to 48
month follow-upmonth follow-up
• Data 111 patients Germany, Switzerland & AustriaData 111 patients Germany, Switzerland & Austria
• Study: legal requirement forStudy: legal requirement for ‘‘newnew’’ productsproducts
• Independent studyIndependent study
• Data is on all types of scarsData is on all types of scars
• Different ages of scarsDifferent ages of scars
• Measurement tool is Vancouver scar scale, whichMeasurement tool is Vancouver scar scale, which
is standard measurement for scarsis standard measurement for scars

58. Sebastian et al, 2005Sebastian et al, 2005
• Patients & physicians assessment ofPatients & physicians assessment of
tolerability and efficacy using 4 point scaletolerability and efficacy using 4 point scale
• Vancouver scar scaleVancouver scar scale

59. Sebastian et al, 2005Sebastian et al, 2005
Results of patient and physician assessment - EfficacyResults of patient and physician assessment - Efficacy
0
10
20
30
40
50
60
% of respondents
Very
G
ood
G
ood
M
oderate
U
nsatisfactory
Patient and Physician assesement of
efficacy
Doctor
Patient

60. Sebastian et al, 2005Sebastian et al, 2005
Results of patient and physician assessment - TolerabilityResults of patient and physician assessment - Tolerability
0
20
40
60
80
100
% of respondents
V
ery
G
oo
d
G
o
od
M
o
d
erate
U
nsatisfactory
Patient and Physician assesement of
Tolerability
Doctor
Patient

61. Sebastian et al, 2005Sebastian et al, 2005
Decrease in Vancouver Scar Scale - RednessDecrease in Vancouver Scar Scale - Redness

62. Sebastian et al, 2005Sebastian et al, 2005
Decrease in Vancouver Scar Scale - ElevationDecrease in Vancouver Scar Scale - Elevation

63. Sebastian et al, 2005Sebastian et al, 2005
Decrease in Vancouver Scar Scale - HardnessDecrease in Vancouver Scar Scale - Hardness

64. Sebastian et al, 2005Sebastian et al, 2005
Decrease in Vancouver Scar Scale - PainDecrease in Vancouver Scar Scale - Pain

65. Sebastian et al, 2005Sebastian et al, 2005
Results by type of scarResults by type of scar
Type of scar (%)
Mature Scar
10%
Major Keloid
10%
Widespread
Hypertrophic
scar
6%Linear
Hypertrohic
scar
40%
Immature
scar
17%
Minor Keloid
17%

66. Sebastian et al, 2005Sebastian et al, 2005
Results by age of scarResults by age of scar
Age of scar (%)
3-6 months
18%
6-12months
23%
12-24 months
11%
>24 months
21% < 3months
27%

67. Summary of studySummary of study
• Kelo-coteKelo-cote® rated:good/very good > 80% patients & physicians® rated:good/very good > 80% patients & physicians
• Physicians rated tolerability:Physicians rated tolerability: good/very good 100% of patientsgood/very good 100% of patients
• Kelo-coteKelo-cote® decreased: redness, elevation, hardness,itchiness® decreased: redness, elevation, hardness,itchiness
and pain of scars over a two month periodand pain of scars over a two month period
• Kelo-coteKelo-cote® can be used on old and new scars® can be used on old and new scars
• Kelo-cote® can be used to treat all types of scarsKelo-cote® can be used to treat all types of scars

68. Indications for useIndications for use
• Kelo-cote® is indicated for the management of:Kelo-cote® is indicated for the management of:
– Acute healing scarsAcute healing scars
– Hypertrophic scarsHypertrophic scars
– KeloidsKeloids
• Kelo-cote®™ has also been used for scars resulting from:Kelo-cote®™ has also been used for scars resulting from:
– TraumaTrauma
– BurnsBurns
– SurgerySurgery
– AcneAcne
– Post laser erythemaPost laser erythema

69. Length of treatmentLength of treatment
• Minimum treatment should be 2 monthsMinimum treatment should be 2 months
• Treat larger and older scars >3 monthsTreat larger and older scars >3 months
• Active persons apply usually in amActive persons apply usually in am
• May treat with other topicals in pmMay treat with other topicals in pm

70. Instructions for use 0.5 oz Kelo-coteInstructions for use 0.5 oz Kelo-cote
• Ensure the area is clean and dry.Ensure the area is clean and dry.
• ApplyApply a very thin layer and allow to drya very thin layer and allow to dry
• Apply once daily, or twice dailyApply once daily, or twice daily
• Maximum effect, 24 hours of continuous contactMaximum effect, 24 hours of continuous contact
• Once dry, OK to cover with pressure garments, sun block orOnce dry, OK to cover with pressure garments, sun block or
cosmeticscosmetics
• If not dried within 4–5 minutes: too muchIf not dried within 4–5 minutes: too much
• Gently remove the excess and allow the dryingGently remove the excess and allow the drying
• Larger and older scars > 90 daysLarger and older scars > 90 days
• 0.5 oz contains enough Kelo-cote®, for: 7.5–10cm 2x/day for 90 days0.5 oz contains enough Kelo-cote®, for: 7.5–10cm 2x/day for 90 days
• Reduce drying time hotter climates, keep in the refrigeratorReduce drying time hotter climates, keep in the refrigerator
• In colder weather, use low setting on hair dryer to reduce drying timeIn colder weather, use low setting on hair dryer to reduce drying time

71. Warnings and PrecautionsWarnings and Precautions
• Avoid direct contact with eyes, mucousAvoid direct contact with eyes, mucous
membranes, & open woundsmembranes, & open wounds
• Kelo-cote® may stain clothing if notKelo-cote® may stain clothing if not
completely drycompletely dry
• Store below 77°F (25°C)Store below 77°F (25°C)
• Do not use after the expiration dateDo not use after the expiration date

72. Mederma: $25, 50g, EtOH, water,PEG-4,xanthum gum,Mederma: $25, 50g, EtOH, water,PEG-4,xanthum gum,
sorbic acidsorbic acid
Scarguard: $72, 100g, with hydrocortisone, Vit EScarguard: $72, 100g, with hydrocortisone, Vit E
Cimeosil: $56, 14 gram, polysiloxanesCimeosil: $56, 14 gram, polysiloxanes
Skin Esthetique: $24, 170g,dimethicone, arnika, copper,Skin Esthetique: $24, 170g,dimethicone, arnika, copper,
seaweedseaweed
Scarfade: $25, 50g, silicone dioxide, micro quartz crystalsScarfade: $25, 50g, silicone dioxide, micro quartz crystals
+/- vit E,K, co-enzyme Q-10+/- vit E,K, co-enzyme Q-10
Pro-Sil: $17.50, glide-on, siliconePro-Sil: $17.50, glide-on, silicone ““creams and oilscreams and oils””

73. • Kelo-cote® is a uniqe patent protected silicone gelKelo-cote® is a uniqe patent protected silicone gel
• 80% patients rate Kelo-cote® as good or very good in scar reduction80% patients rate Kelo-cote® as good or very good in scar reduction
• 100% physicians rate Kelo-cote® good or very good in pt tolerability100% physicians rate Kelo-cote® good or very good in pt tolerability
• Kelo-cote® softens, flattens &reduces the redness of old & new scarsKelo-cote® softens, flattens &reduces the redness of old & new scars
• Kelo-cote® is a comaparatively cost effective treatmentKelo-cote® is a comaparatively cost effective treatment

74. Clinicial Care:Clinicial Care:’’OlsenOlsen’’s Rules Rule’’
• ““Most wounds heal proportionate to the time andMost wounds heal proportionate to the time and
attention they are givenattention they are given””
• Steristrip minimum of 4 - 7 days & then another 5 daysSteristrip minimum of 4 - 7 days & then another 5 days
after changing stripsafter changing strips
• Early application of Kelo-cote, avoid any contact withEarly application of Kelo-cote, avoid any contact with
clothing for 6 weeks minimum: diapers OKclothing for 6 weeks minimum: diapers OK
• All open wounds treated with 1/2 peroxide, bacitracin,All open wounds treated with 1/2 peroxide, bacitracin,
minimum of twice dailyminimum of twice daily

75. HandHand

76. Breast ReductionBreast Reduction

77. Breast AugmentationBreast Augmentation

78. Mastopexy AugmentationMastopexy Augmentation

79. Verbal testimonial: Mastopexy AugmentationVerbal testimonial: Mastopexy Augmentation

80. Breast Cancer ReconstructionBreast Cancer Reconstruction
• Bilateral Transverse Rectus Abdominus Myocutaneous FlapBilateral Transverse Rectus Abdominus Myocutaneous Flap

81. AbdominoplastyAbdominoplasty
<Olsen<Olsen’’s Rules Rule

83. Facial TraumaFacial Trauma

84. FaceliftFacelift

85. Head and Neck Excisional SurgeryHead and Neck Excisional Surgery

86. Cleft Lip SurgeryCleft Lip Surgery

87. Looking into the FutureLooking into the Future
Bioglass and nano crystal Silver SprayBioglass and nano crystal Silver Spray