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RESULTS • Wound contraction was slightly greater for foam (both MHC Avance & V.A.C. GranuFoam) than for gauze. • Wound contraction is the same when using Mepitel and Mepitel One. • There is more pronounced granulation tissue formation with foam (green and black) than with gauze. • Granulation tissue formation is slightly greater under foam than under gauze and in the presence of a wound contact layer (in this case, Mepitel and Mepitel One) • Degree of granulation tissue is similar for both Avance foam and V.A.C. GranuFoam. • Wound bed tissue grows into foam but not into gauze. • Degree of tissue ingrowth is similar for both Avance foam and V.A.C. GranuFoam. • This is reflected in findings of case studies showing gauze to be easier to remove. • Removal of AMD gauze does not disrupt the wound bed and may lessen patient pain during dressing changes. • The presence of Mepitel and Mepitel One hinders in-growth and lessens the force needed for removal of foam in NPWT. Waring M, Bielfeldt S, Brandt M INTRODUCTION • From a clinical perspective, NPWT is superior to standard moist wound care in a variety of wound types. • 15 RCTs of varying quality indicate superiority and safety from a clinical perspective. • Majority of trials involve KCI’s V.A.C. system using foam. • The Avance NPWT system is suitable for use with both foam and gauze. • Recommended pressure levels for Avance vary, depending on filler type: – Avance foam (-120 mmHg) – AMD gauze (-80 mmHg) AIMS • Demonstrate equivalency of MHC Avance NPWT green foam system with KCI’s V.A.C. black foam system, for which there is already a large evidence base (15 RCTs). • Achieve this by drawing on data from an MHC animal study comparing KCI V.A.C. GranuFoam with MHC Avance foam. • Demonstrate equivalency of the gauze component of the Avance system with other systems using gauze. • Show that Mepitel ® One performs in a similar way to Mepitel ® in conjunction with NPWT. METHODS MHC-sponsored animal studies involving eight healthy domestic pigs: • Effects of MHC Avance foam, AMD gauze, and KCI V.A.C. GranuFoam were compared. • Biological effects of Mepitel/Mepitel One, used as interpositional dressing, were assessed. Measures compared in the first MHC study included: • Mechanical effects (contraction). • Quantity and quality of granulation tissue with different fillers. • Wound bed tissue ingrowth into the wound filler. Measures compared in the second MHC study were: • Pressure transduction. • Blood flow in the wound bed. ANIMAL STUDY 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 Before NWPT NPWT, Oh NPWT, 24h NPWT, 48h NPWT, 72h After NWPT 102 100 98 96 94 92 90 Wound surface area (% change) Gauze, with NPWT Before NWPT NPWT, Oh NPWT, 24h NPWT, 48h NPWT, 72h After NWPT 102 100 98 96 94 92 90 Wound surface area (% change) MHC foam, with NPWT Before NWPT NPWT, Oh NPWT, 24h NPWT, 48h NPWT, 72h After NWPT 102 100 98 96 94 92 90 Wound surface area (% change) VAC foam, with NPWT Gauze, 0mmHg Gauze, -120mmHg Gauze, layer 1 -120mmHg Gauze, layer 2 -120mmHg Green foam, 0mmHg Green foam, -120mmHg Green foam, layer 1 -120mmHg Green foam, layer 2 -120mmHg Black foam, 0mmHg Black foam, -120mmHg 6 4 2 0 Average force (N) Average force 1 = Mepitel 2 = Mepitel One

description

biológicos efectos de la terapia de presión negativo en el proceso de granulación de las ulceras

Transcript of negative pressure wound therapy

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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

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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).

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