RESULTS

•Woundcontractionwasslightlygreaterforfoam(bothMHCAvance&V.A.C.GranuFoam)thanforgauze.

•WoundcontractionisthesamewhenusingMepitelandMepitelOne.

•Thereismorepronouncedgranulationtissueformationwithfoam(greenandblack)thanwithgauze.

•Granulationtissueformationisslightlygreaterunderfoamthanundergauzeandinthepresenceofawoundcontactlayer(inthiscase,MepitelandMepitelOne)

•DegreeofgranulationtissueissimilarforbothAvancefoamandV.A.C.GranuFoam.

•Woundbedtissuegrowsintofoambutnotintogauze.

•DegreeoftissueingrowthissimilarforbothAvancefoamandV.A.C.GranuFoam.

•Thisisreflectedinfindingsofcasestudiesshowinggauzetobeeasiertoremove.

•RemovalofAMDgauzedoesnotdisruptthewoundbedandmaylessenpatientpainduringdressingchanges.

•ThepresenceofMepitelandMepitelOnehindersin-growthandlessenstheforceneededforremovaloffoaminNPWT.

Waring M, Bielfeldt S, Brandt MWounds UK 2009; 5 (3): 22-31

INTRODUCTION

•Fromaclinicalperspective,NPWTissuperiortostandardmoistwoundcareinavarietyofwoundtypes.

•15RCTsofvaryingqualityindicatesuperiorityandsafetyfromaclinicalperspective.

•MajorityoftrialsinvolveKCI’sV.A.C.systemusingfoam.

•TheAvanceNPWTsystemissuitableforusewithbothfoamandgauze.

•RecommendedpressurelevelsforAvancevary,dependingonfillertype:

–Avancefoam(-120mmHg)

–AMDgauze(-80mmHg)

AIMS

•DemonstrateequivalencyofMHCAvanceNPWTgreenfoamsystemwithKCI’sV.A.C.blackfoamsystem,forwhichthereisalreadyalargeevidencebase(15RCTs).

•AchievethisbydrawingondatafromanMHCanimalstudycomparingKCIV.A.C.GranuFoamwithMHCAvancefoam.

•DemonstrateequivalencyofthegauzecomponentoftheAvancesystemwithothersystemsusinggauze.

•ShowthatMepitel®OneperformsinasimilarwaytoMepitel®inconjunctionwithNPWT.

METHODS

MHC-sponsoredanimalstudiesinvolvingeighthealthydomesticpigs:

•EffectsofMHCAvancefoam,AMDgauze,andKCIV.A.C.GranuFoamwerecompared.

•BiologicaleffectsofMepitel/MepitelOne,usedasinterpositionaldressing,wereassessed.

MeasurescomparedinthefirstMHCstudyincluded:

•Mechanicaleffects(contraction).

•Quantityandqualityofgranulationtissuewithdifferentfillers.

•Woundbedtissueingrowthintothewoundfiller.

MeasurescomparedinthesecondMHCstudywere:

•Pressuretransduction.

•Bloodflowinthewoundbed.

ANIMALSTUDY

Evaluation of MHC Avance™ foam, KCI V.A.C.® GranuFoam,™ and gauze for negative pressure wound therapy (NWPT): Biological effects on the wound bed including granulation quantity, tissue ingrowth into wound filler, delivery of negative pressure to wound bed, and blood flow in the wound bed

Malin Malmsjö MD, PhD, Lund University, Sweden. Poster presented at EWMA 2010

Bef

ore

NW

PTN

PWT,

Oh

NPW

T, 24

hN

PWT,

48h

NPW

T, 72

hAf

ter N

WPT

102

100

98

96

94

92

90

Wou

nd s

urfa

ce a

rea

(% c

hang

e)

Gauze, with NPWT

Bef

ore

NW

PTN

PWT,

Oh

NPW

T, 24

hN

PWT,

48h

NPW

T, 72

hAf

ter N

WPT

102

100

98

96

94

92

90

Wou

nd s

urfa

ce a

rea

(% c

hang

e)

MHC foam, with NPWT

Bef

ore

NW

PTN

PWT,

Oh

NPW

T, 24

hN

PWT,

48h

NPW

T, 72

hAf

ter N

WPT

102

100

98

96

94

92

90

Wou

nd s

urfa

ce a

rea

(% c

hang

e)

VAC foam, with NPWT

Gauz

e, 0

mm

Hg

Gauz

e, -1

20m

mH

g

Gauz

e, la

yer1 -

120m

mH

g

Gauz

e, la

yer2 -

120m

mH

g

Gree

n fo

am, 0

mm

Hg

Gree

n fo

am, -

120m

mH

g

Gree

n fo

am, la

yer1 -

120m

mH

g

Gree

n fo

am, la

yer2 -

120m

mH

g

Bla

ck fo

am, 0

mm

Hg

Bla

ck fo

am, -

120m

mH

g

6

4

2

0Aver

age

forc

e (N

)

Average force

1 = Mepitel2 = Mepitel One

WC–C–070–2PS/1

CONCLUSIONS

•MHCanimalstudiescomparingMHCAvancefoamwithV.A.C.GranuFoamdemonstrateequivalencytoKCIV.A.C.GranuFoamformultipleparameters.

•Similarly,MHCanimalstudiesusinggauzepackingmirrorpublishedfindingsofothersystemsusinggauzepacking.

•OthermeasuresnotconsideredinMHCstudiesbutverifiedinKCIclinicalstudies,suchasreducedtimetoachievewoundclosure,mightreasonablybeachievedwiththeAvancesystem.

•MepitelandMepitelOnedemonstrateequivalenceincombinationwithNPWT,lessin-growthunderfoamsupportsotherstudieswithrespecttoreducedlevelsofpain.

MölnlyckeHealthCareAB(publ)Box13080,SE-40252Göteborg,SwedenPhone+46317223000.www.molnlycke.com

TheMölnlyckeHealthCarenameandlogo,Avance,™Safetac®andMepitel®areregisteredtrademarksofMölnlyckeHealthCare.

•OptimalpressuretransductionwithMHCfoam,V.A.C.GranuFoam,andgauze.

•Allthreefillerswerecomparable.

•WhenusingSafetac®technology(MepitelandMepitelOne),woundbedpressuresachievedwerereduced.

•NPWTinducedanincreaseinthewoundedgemicrovascularbloodflowat2.5cmfromthewoundedge.

•At0.5cmfromthewoundedge,adecreaseinbloodflowwasnoted.

•ObservationsregardingbloodflowweresimilarforMHCgreenandKCIblackfoam.Gauzehadslightlylesspronouncedbloodfloweffects,especiallyat0.5cmfromthewoundedge.

•Increasedbloodflowfacilitatesoxygenation,nutrientsupplyandremovalofwasteproducts.

•Decreasedbloodflowstimulatesangiogenesisandgranulationtissueformation.

•MHCAvancefoam(green)allowseasiermonitoringofwoundstatussinceexudateandbleedingareeasiertoseethanintheblackGranuFoam.

OutcomesfromRCTswithKCI’sV.A.C.system,whichdemonstrationofequivalencesuggestswouldbesimilarwithAvance:

•Reducednumberofdaysrequiredtoachieve100%re-epithelialisation.

•Reducedneedforsecondaryamputationsinpatientswithdiabeticfootulcers.

•Reductioninthenumberofdaysrequiredtoachievecompletehealing.

•Reducedneedforre-grafting.

•Reductionintimetostopwoundexudate.

•Reductionofbacterialevelsininfectedwounds.

•Increasedrateofgranulationtissueformation.

•Increasedratesofachievingsuccessfulskingrafts.

•Increasedreductioninwoundvolumeat6weeks.

•Increasedulcerwidthreductionat6weeks.

•Increasedgrafttake.

ClinicalstudiesusinggauzesupportingclaimsforNPWTandpossiblyreplicablewithAvance:

•Median88%reductioninvolume(p<0.001).

•68%reductioninarea(p<0.001).

Greenfoam Blackfoam Gauze

0

-20

-40

-60

-80

-100

-120

-140

-160

Wou

nd b

ed p

ress

ure

(mm

Hg)

0 -20 -40 -60 -80 -100 -120 -140 -160Set negative pressure (mmHg)

Green foam

Black foam

Gauze

1009080706050403020100

-10-20-30-40-50

Blo

od fl

ow (%

of b

asel

ine)

20 40 60 80 100 120Negative pressure (-mmHg)

Black foam, 0.5cmBlack foam, 2.5cm

Green foam, 0.5cmGreen foam, 2.5cm

Gauze, 0.5cmGauze, 2.5cm