Evidence of innovation - Supplier of Ostomy and Wound Care · the accessories range, where Welland...

Evidence ofinnovation

“YOU CAN'T SOLVE A PROBLEM ON THE SAME LEVEL THAT IT WAS CREATED. YOU HAVE TO RISE ABOVE IT TO THE NEXT LEVEL.”Albert Einstein Contents

_4 Innovators In Stoma Care_6 History Of Innovation_8 Ostomy Challenges_10 User Centric Innovation_12 A Natural Based Hydrocolloid Adhesive_13 Case Studies. Real People, Real Results_38 Manuka Honey And Skin Health_42 The Evolution Of Flange Extenders_44 UltraFrame® Evaluation In Ostomates With Active Lifestyles_48 ‘Ironman’ Jack. Life After Surgery_51 References

2 3

WELLAND MEDICAL EVIDENCE OF INNOVATION

AtWellandMedicalweworkcloselywithhealthcareprofessionals,patientsandcareorganisationstodevelopinnovativeproductsthatenhancethelivesofostomatesthroughouttheworld.

WearepassionateaboutResearchandDevelopmentandcontinuouslystrivetoadvanceourproducts.Manyofourideascomefromthosewithastomausingostomyproducts,whounderstandfirst-handtheday-to-daychallengesassociatedwiththem.

OUR MISSIONTobringtomarketinnovativeproductsthatenhancethelivesofostomatesthroughouttheworld.

OUR VALUESExcellenceBethebestineverythingthatwedobypromotingacultureofcontinuousimprovementforouremployees,productsandservices.

InnovationForwardthinkingtoachievegrowthbyidentifyingopportunitiestosupplycreativeandnovelsolutionsthatdeliveroutstandingvaluetostakeholders.

IntegrityConductourselvesfinancially,sociallyandenvironmentallyinaprofessionalandethicalmannerwithfairness,honestyandrespect.

QualityCommittedtothedeliveryofhighqualityproductsandservicestoallourcustomers.

Health, Safety and WellbeingProvideaclean,safe,secureandhealthyworkingenvironmentwhereourstaffaresupportedinfulfillingagoodworklifebalance.

WE ARE ‘INNOVATORS IN STOMA CARE’...

4 5


...WITH A HISTORY OF TURNING OLD PROBLEMS INTO NEW INNOVATIONS.

1988

1989

1996

1997

1999

2001

2002

2003

2004

2005

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

WellandMedicalfounded.

Medical Adhesive Removerlaunched.

Aurum® Convex and Aurum® Profile poucheslaunched.

IMPACT,theworld'sfirstflushablecolostomypouchlaunched.

TwoSMARTAwardsreceivedfortheinnovationandmarketingofIMPACT.

Flair Active®closedanddrainablepoucheslaunched.

Flair Active® Xtraflushablepouchlaunched.

Flair Xtra®flushablepouchlaunched.

Integralclosuresystemfordrainablepouchesintroduced.

WBF®barrierwipesandspraylaunched.

IMPACTawardedMillenniumProductStatusbytheUKDesignCouncil.

AchievedInvestorsinPeoplestatus.

WellandMedicalcelebrates25years.

AchievedInvestorsinPeopleChampionstatus.

Aurum®withManukahoneyonepiecerangelaunched.

Sixnewaccessoryproductslaunchedincluding:Barrier Spray, Stoma PasteandStoma Powder.

Multi-purpose rangelaunchedincludingpaediatricandwoundcarepouches.

Aurum® Xtraflushablepouchlaunched.

Aurum®2poucheslaunched.

Night drainage bag andEasiflo™launched.

ReaccreditedInvestorsinPeopleGoldstatus.

Flair® Convexpoucheslaunched.

Flair®2closedanddrainablepoucheslaunched.

Liberty IIthefirsttwo-piecepoucheslaunched.

SussexBusinessAwardforIMPACT.

JoinedCliniMedgroupofcompanies.

Firsturostomypoucheslaunched.

FirstWellandMedicalclosedanddrainablepoucheslaunched.

Flair Active®andFlair®2urostomypoucheslaunched.

AchievedInvestorsinPeopleSilverstatus.

Curvex®firstpoucheslaunched.

Flair Active®ConvexandCurvex®poucheslaunched.

AchievedInvestorsinPeopleGoldstatus.

Flair®closedanddrainablepoucheslaunched.

HydroFrame®,theworld'sfirstflangeextenderlaunched.

HydroFrame®flangeextenderandHyperSeal® Washers with

Manuka Honeylaunched.

UltraFrame®flangeextenderlaunched.

HyperSeal® Washers-3newsizesintroduced.

WellandMedicalcelebrates30years.

Flair Active® Post Op Pouchlaunched.

6 7


OSTOMYCHALLENGES

8 9

>38%

Faecaldermatitis

Mechanicaldermatitis

PERISTOMAL SKIN PROBLEMS*¹

EFFECT ON QUALITY OF LIFE*2

Classification of peristomal skin problem...

Coupling Failure...

>47%


50%experiencedcouplingfailure.

81%worriedaboutbagnotbeingsecurelyfastenedtobaseplate.

91%worriedaboutleakage.

76%experiencedlowtoveryhighdegreeofleakage.

>43%ofpatientsareaware.

Lessthan1in5seektreatment.

16%

patientspresentwithaskinproblem.

c.45%

Leakage issues...

USER CENTRICINNOVATION

10 11

Dr Arash Moavenian, Head of Research and Innovation

ArashcompletedhisDoctorate(PhD)attheUniversityofCambridgein2012.AsHeadofResearchandInnovationatWellandMedical,Arashandhisteamareresponsiblefornewproductinnovation,blue-skyprojectsandacademicandclinicalcollaborations.

OneofArash’searliestprojectsatWellandMedicalwastheselectionofthesource,supplyandgradeofmedicalgradeManukahoneyusedintheAurum®ostomyrange.

SincethenArashandhisteamhavebuiltastrongcollaborativenetworkwithuniversitiesacrosstheUKtofurtherdriveforwardandsupportWellandMedical’sresearchcapabilities,withaparticularfocustobroadenthescopeofresearchinskinhealth.ArashandhisteamendeavortocontinuouslystrengthentheresearcharmofWellandMedicalasabasisfromwhichtodrivethroughhighimpactinnovations.

ResearchandDevelopmentisattheheartofouractivitiesatWellandMedicalandcentraltorealisingourvision–InnovatorsinStomaCare.AsaBritishmanufacturingcompany,establishedin1988,wearetodayamajorglobalplayerinthefieldofostomy,andIhavetheprivilegeofworkingwithastrong,passionateanddynamicteamdeliveringthehighestqualityandinnovativeproductstoourendusers.

Creatingtruevaluethroughnewproductdevelopmentreliesonadeepunderstandingofuserneeds,challengesanddesires.Thepatient-centricapproachweemploy,coupledwiththeinquisitiveandskilleddevelopmentteam,headedupbyMarkNewton,playsanintegralpartinensuringthatweprovideproductsthatenhancethelivesofostomates,andthisunderpinsourmission.Further,ourvaluepropositionextendsalongthestakeholderchain,ensuringthatproductsareavailableaswidelyaspossibleacrossdifferenthealthcarereimbursementstructuresandtousersaroundtheworld.

ARASH AND HIS TEAM ARE RESPONSIBLE FOR NEW PRODUCT INNOVATION, BLUE-SKY PROJECTS AND ACADEMIC AND CLINICAL COLLABORATIONS.

Theostomypouchcanbeperceivedasasimplemedicaldevicecomprisingofacollectionpouchandaskinadhesivethatattachesthebagtothebody.However,theplethoraofdevicesandaccessoryproductsonthemarket,eachtailoredtoaparticularpatientgroup,presentsjustoneindicatorofthecomplexityinmanagementofastoma;therearemajorphysicalandpsychologicaluserconsiderationsinnewproductdesign,whichincludesecureyetatraumaticattachment,managementofodour,discretionandcomfort,andthisallpresentsastimulatingandchallengingarenaforinnovation.

Oneofourlatestinnovations,theAurum®range,buildsuponthetrusted,naturalandeffectivehydrocolloidformulationwehaveestablishedforthreedecades,throughtheincorporationofManukahoneyintotheskinadhesive.Thishasproventobeeffectiveasaninterventioninproblematicskinandisbeingadvocatedforuseinmaintaininghealthyperistomalskincondition.Anotherisintheaccessoriesrange,whereWellandMedicaldevelopedthefirsthydrocolloid-basedflangeextenderinthemarket,HydroFrame®andmorerecentlylaunchedtherevolutionaryUltraFrame®,whichistheworld’sthinnest,mostconformableanddiscreetflangeextender.

Weareincreasinglyplacingfocusonsupportingandempoweringcareprovidersandostomateswithrobustscientificandclinicaldatarelatingtoourinnovativeproducts;thisisbeingachievedthroughbroadeningouracademiccollaborationsacrossworld-classinstitutionsandcontinuousstrengtheningofourin-houseresearchcapabilities.OurcommitmenttohighimpactinnovationdrivesandmotivatesourR&Dactivitiesandwelookforwardtocontinuingtoshapethefutureofostomyproductsandimprovingqualityoflifeforostomates.

“THE BEST WAY TO PREDICT THE FUTURE IS TO CREATE IT.”Alan Kay


“

“

A NATURAL BASED HYDROCOLLOID ADHESIVE Honeyhaslong-standingrecognitionforitsantibacterialandanti-inflammatoryproperties,datingbacktoitsuseinthetreatmentofwoundsbytheancientEgyptians.

Today,productscontaininghoneyremainaninterventionofchoicewithinthewoundcaresetting,withagrowingwealthofscientificresearchdemonstratingthespecificanduniqueefficacyofManukahoneyinwoundhealing*1.

ThebioactivitylevelsofManukahoneyhavebeenshowntobedirectlylinkedtothelevelofmethylglyoxal(MGO)present,akeyandunique

componentfoundinmono-floralhoney’soriginatingfromtheManukaflower,indigenoustoNewZealand.WellandMedicalhasselecteda16+UMFManukahoney,containinghighlevelsofMGOforusewithinitshydrocolloid-basedskinadhesive,buildingonthenaturalhydrocolloidformulationusedsuccessfullyforalmostthreedecades.

12

OURINNOVATIONS

CASE STUDIES& EVALUATIONS

13

EVALUATION OF THE USE OF HYDROCOLLOID CONTAINING MANUKA HONEY IN OSTOMY CAREThisseriesofcasestudiesaimstoevaluatetheeffectivenessofhydrocolloidwithManukahoneyaspartofatreatmentplanforpatientswithirritatedperistomalskin.

Eachofthesecasestudieswererecordedbytheattendingnurseorconsultantandarepresentedasfirst-handaccountsofthedevelopmentoftreatmentandtheresponseofeachpatient.Theconditionofeachpatientwasassessedthroughoutandpatientswerecloselymonitoredeitherduringtheirstayinhospitalorthroughhomevisits.

>>>WELLAND MEDICAL EVIDENCE OF INNOVATION

OUTCOME AND FOLLOW UPAfter2monthsofthisroutinethedermatitishadimprovedandtheweartimeincreasedtojustlessthan24hours(Figure2).Panos’familyonlyhavetospendafewminutesadaytakingcareofhisstoma.Hecanplayandbeactivewithoutconsequencesandhisparentshavegainedmoreconfidenceinhelpingandsupportinghimlivewithhisstoma.

Panosisnolongerreluctantwhenitcomestochanginghispouchandtheprocedurehasbecomemucheasierforbothhimandhisparents.

DIAGNOSIS AND TREATMENTPanosunderwentsurgeryforMegacolonandatemporaryileostomywasformedwhenhewas2yearsold.

Panos,now5yearsold,wasveryactivebeforehissurgeryandcontinuedtobesoafterbuthedidn’tunderstandwhyhehadtowearapouch.Thepouchhewaswearingonlystayedonhisskinforafewhoursatatime.Thisresultedinextendedandpainfuldermatitisaroundhisstoma(Figure1).

Duetothedermatitis,Panoswasreluctanttowearapouch.Thismadechanginghispouch,whichwasrequired6or7timesaday,verydifficultforhisparents.

HisparentsinformedtheirdoctorandGeneralChemicalProductsS.Awerecontacted.IwassenttovisitthefamilyandsuggestedusinganAurum®1pieceileostomypouch.

Eosinsolutionwasusedforapproximately2½weeksandthereafterWBF®Spraywasusedbetweenpouchchanges.Withinthefirstmonthofstartingthisroutinetheweartimeofeachpouchhadincreasedupto12hours.WellandMedicalAdhesiveRemoverSprayandWipeswereusedtominimiseanypain.

Aurum®withManukahoneyileostomypouchandWBF®spray

AnindependentaccountbyThanassisPavlopoulos,SalesSupervisor

PatientMale,5,temporaryileostomysince2011(Megacolon)

SourceThanassisPavlopoulos,SalesSupervisor,GCPMedical,Greece

ProblemNegativeskinreaction

TreatmentAurum®withManukahoney1pieceileostomypouchandWBF®spray

14 15Figure1 Figure2


Data held on file.The views and opinions expressed in this article are those of the source and do not necessarily reflect the views and opinions of Welland Medical.

CASE STUDY

OUTCOME AND FOLLOW UPAfter2weeksthedermatologistobservedthatMr.B’sskinshowedsignsofimprovement.Onlysomesmallsectionsofskinwerestilldamaged(Figure2).

Mr.Breportedtofeelverywellandcomfortable.

DIAGNOSIS AND TREATMENTMr.B.arrivedathospital(DermatologyDepartment)presentingitching,redandbruisedperistomalskin.Thefirstskinlayerwasdamagedandsmallblistersfilledwithfluidshowedearlystagesofanallergicreaction(Figure1).Toremedythis,theheaddermatologistusedEosinwhichhelpedtoreducethesymptoms.

Theheaddermatologistcontactedmeashewantedtofindoutifthepatientwouldexperienceanallergicreactiononotherstomaproducts.WeconductedapatchtestwithpiecesoftheadhesiveofWellandMedicalFlair®2,WellandMedicalAurum®and4otherstomaproducts.

Thepatchof1stomaproductdidnotstickwell,theothersstayedonfor48hoursinstage1andthen72hoursinstage2,withtheresultsshowingnoreactiononthearm.AnAurum®1pieceileostomypouchwasselectedasMr.B’sreplacementproduct.

CASE STUDYAurum®withManukahoneyileostomypouch

AnindependentaccountbyBerndGinsberg,EnterstomalTherapist

Figure1 Figure2

PatientMale,71,colostomysince1989(coloncancer)

SourceBerndGinsberg,EnterostomalTherapist,WegimedGmbH,Germany


TreatmentAurum®withManukahoney1pieceileostomypouch

16 17



OUTCOME AND FOLLOW UPOnherreturntoclinicthepatientreportedthepouchtobecomfortableshefounditeasytoapplyandherperistomalskinhadhealed.

AsignificantimprovementintheperistomalskinwasobservedbytheStomaCareNurse(Figure2).

DIAGNOSIS AND TREATMENTA69yearoldfemaleselfreferredtotheStomaClinicwithperistomalskinsoreness.ThisladywasfirstreferredtotheStomaCareTeamin2009witha3yearhistoryofCrohnsDiseasetodiscusshersurgicaloptions.

PanproctocolectomywithendileostomywasperformedinAugust2009.Followinganuneventfulrecoveryshewasdischarged7dayspostoperativelyusinganalginatedrainableappliancewhichsuitedherdelicateskin.Shehasbeenreviewedregularlyinthestomaclinicsincedischargewithnoperistomalskinproblems.

InearlyJuneof2013thisladypresentedtotheStomaClinicwithaweeklonghistoryofsore,wet,peristomalskinpreventingpouchadhesionsubsequentlyresultinginleakageissues.Onexaminationtheperistomalskinwasredandmacerated(Figure1).

AskinpowderwasappliedtodrytheperistomalskinandthenewAura®*midisplitcoverdrainablepouchwasutilisedwitheffectiveadhesion.ThisnewrangeofproductsarethefirsttocontainmedicalgradeManukahoneyintheflange;hencethereasonfortryingthisparticularpouchonthispatient.

Thepatientwasaskedtoreturntotheclinicin1weektoreviewtheeffectivenessofthealternativeproductwithherskinproblem.

CASE STUDYAura®*withManukahoney1pieceileostomypouchandWBF®spray

AnindependentaccountbytheStomaCareTeamatGreatWesternHospitalsFoundationTrust

PatientFemale,69,Ileostomysince2009(CrohnsDisease)

SourceStomaCareTeamGreatWesternHospitalsFoundationTrust

ProblemPeristomalskinsoreness.Relevantpastmedicalhistory.Patienthaslifelongpsoriasis

TreatmentAura®*withManukahoney1pieceileostomypouchandWBF®spray




*Aurum® is branded Aura® in the UK

OUTCOME AND FOLLOW UP6weeksaftermyfirstvisitIvisitedthepatientagain.Thisexaminationshowedthatthepatient’sskinhadremainedveryslightlyred,duetoherpsoriasis,buttheitchinganddiscomforthadstoppedandthebruisinghadrecovered(Figure2).ThepatienttoldmethatshefeltcomfortablewithherAurum®pouchandtoldmethatsheplannedtocontinueusingit.

DIAGNOSIS AND TREATMENTA73yearoldfemalewithanileostomyhadahistoryofperistomalskinissuesthatrelatedtoherpsoriasis.Shehadundergone15abdominaloperationsandhadusedmultiplebrandsandstylesofpouch.ThepatientcontactedtheWellandNederlandserviceteamafterreadingaboutAurum®withManukahoney.

Ivisitedthepatient’shomeandobservedshewasexperiencingsymptomsincludingitching,discomfort,bruisedanddiscolouredperistomalskin.Damagetothetoplayerofherskinwascausingleakagetooccurseveraltimesaweek(Figure1).Thepatienttoldmethatherconditionhadmadeherfeelinsecureandisolated.IadvisedhertostartusingAurum®1pieceileostomypoucheswhichshedidimmediatelyaftermyfirstvisit.

6dayslaterIcouldseethattheconditionofherskinhadimproved,theitchinghadstoppedandshehadnotexperiencedanyleakagesincemyfirstvisit.16dayspassedbeforeIreturnedforanothervisitwhenIobservedthatherskinhadalmostcompletelyhealedandthepatienttoldmethatshehadbeguntoleavethehousemoreregularly.

CASE STUDYAurum®withManukahoneyileostomypouch

AnindependentaccountbyTheoTromp,NursingConsultant

PatientFemale,73,ileostomysince2007(coloncancer)

SourceTheoTromp,NursingConsultant,WellandNederland,TheNetherlands

ProblemNegativeskinreactionlinkedtopsoriasisandleakage

TreatmentAurum®withManukahoney1pieceileostomypouch




OUTCOME AND FOLLOW UPIcarriedoutmylasthomevisit17dayslaterandtookapictureofthepatient’speristomalregion(Figure2).ThepatientreportedthathewasverycomfortableandconfidentwithhisAurum®pouches.

Thepatient’speristomalskinconditionhadimprovedsignificantlyinjustover3weeksfollowingthesechangestohisroutine.

DIAGNOSIS AND TREATMENTA67yearoldmalewithacolostomyhadbeensufferingfromcomplicationswithhisperistomalskinrelatingtohisprolapsedstoma.Duringahomevisiton22ndSeptemberhedescribedhisskinasitchyandred.UponinspectionInoticedthattheskinwasalsoverymoistandappearedtobereactingtocontactwithhisstoma’soutput(Figure1).

ThepatientexplainedthathehadbeenexperiencingleakageandIbecameawarethatthehewasexperiencingdifficultieswiththeapplicationofhispouch.OnceIhadcorrectedthis,IadvisedthepatienttostartusingAurum®1piececolostomypouches.Thepatientthenreceivedfurthertraininginhowtomanagehisprolapsedstomaandhowtoapplyhispouchcorrectly;thisincludedusingcoldwatertotemporarilyreducedthesizeofthestoma,makingapplicationeasier.

Ireturnedtothepatient’shome6dayslater,hereportedthathehadnotexperiencedanyleakagesincemylastvisit.Iobservedthathisskinwasstillslightlyredbutthemoisturehaddecreasedandtheskinwasnotasitchy.

CASE STUDYAurum®withManukahoneycolostomypouch

AnindependentaccountbyTheoTromp,NursingConsultant

PatientMale,67,colostomysince2005(coloncancer)

SourceTheoTromp,NursingConsultant,WellandNederland,TheNetherlands

ProblemNegativeskinreactionlinkedtoleakage

TreatmentAurum®withManukahoney1piececolostomypouch




OUTCOME AND FOLLOW UPWedecidedthateachconvexflangewouldbeappliedforamaximumof48hours.After4dayshadpassed,themoistureleveloftheperistomalskinhadreduced(Figure2).Thepatientreportedthatshefeltwellandcomfortablewithhernew2piecepouchesandwasdischargedfromthehospitalthenextday.

DIAGNOSIS AND TREATMENTTheWellandNederlandServiceTeamwasapproachedbyastomanursefromalocalhospitalwhowantedourhelpwithapatientwhowassufferingfrommoist,redandirritatedperistomalskin.Inordertoidentifythecause,Ivisitedthepatientinhospitalthefollowingmorning.

Duringthisvisit,Iobservedthatthedamagetothepatient’speristomalskinwasbeingcausedbycontinuedandextendedcontactwithherstoma’shighlevelofoutput(Figure1).

Thepatient’sileostomywasrecessedbelowherskinlevelwhichmeantthatshewasexperiencingleakageonaregularbasis.ThehospitalnurseswereapplyingwhatIfeltwastoomuchstomapowdersoIdecidedtothoroughlycleantheperistomalskintoremovethis.

Aftertheperistomalskinwascleaned,weappliedanAurum®2piececonvexurostomyflangewithanileostomypouch.Theoutputwasparticularlywateryandaggressivesotheconvexurostomyflangewaschosentoextendtheweartimeofeachflange.Thehospitalnurseswereworriedtherewouldbeleakageduringthenightbutregularexaminationsshowedthatnoleakageoccurredwhilethepatientwaswearingtheconvexflange.

CASE STUDYAurum® 2convexurostomyflangewithManukahoneyandAurum® 2ileostomypouch

AnindependentaccountbyNellekevandeVliert,NursingConsultant

PatientFemale,75,ileostomy

SourceNellekevandeVliert,NursingConsultant,WellandNederland,TheNetherlands


TreatmentAurum®2piececonvexurostomyflangewithManukahoneyandAurum®2pieceileostomypouch




OUTCOME AND FOLLOW UPThecarehomenursesreportedthattheycannowconfidentlyusethewashersandcuttheflangetotherightsize.IinstructedthecarehomenursestocontinueusingtheHyperseal®washerswithManukahoneyaswellastheFlairActive®PostOppouchtoassistwiththehighoutput(Figure2).

Mrs.C.reportedthatshefeelsmorecomfortablesincethepainhasreduced.

DIAGNOSIS AND TREATMENTMrs.C.livesinacarehomeandhasAlzheimer’sDisease.Shehasaloopileostomywithahighoutputandwasexperiencingleakageandskinproblems.

Thecasewasreferredtoahospitalnursewhoaskedmetojoinherinthiscasestudy.Mrs.C.wasalreadyusingaWellandMedicalFlairActive®PostOppouch.

Afterinspectionofthestomaandtheproducts,Iconcludedthattheflangewasnotcuttotherightsize(toosmall)andtheskinwasdamagedbyfaeces(Figure1).Icuttheflangetotherightsizeandpreparedanewtemplate.

Iadvisedthehospitalnursetostartthepatientonoralmedicationtothickenthefaeces,whichwassuccessful.IalsoappliedtheHyperseal®washerswithManukahoneyaroundthestomainpiecesbecausethesizeofthestomaisrelativelybig.

CASE STUDYHyperseal® washerswithManukahoney

AnindependentaccountbyE.Biesaart,NursingConsultant

PatientFemale,78,loopileostomy

SourceE.Biesaart,NursingConsultant,WellandNederland,TheNetherlands


TreatmentHyperseal®washerswithManukahoney




OUTCOME AND FOLLOW UPAfollowupexaminationwascarriedout15daysafterthefirstAurum®pouchapplicationandtheconditionoftheskinwasassessedonceagain(Figure2).After2weeksoftreatmentandexaminationstheskin’scolourandmoisturehadimproved.

DIAGNOSIS AND TREATMENTA62yearoldfemalediagnosedwithrectalcancerunderwentanabdominoperinealresection(Milesoperation)andacolostomywasformed.Followingthesurgery,Iputthepatientonacompetitor’scolostomypouch.

Inthedaysfollowingthesurgery,examinationshowedtheskinaroundthestomahadbecomeedematousbutwithouterosiveorulcerativelesions(Figure1).

IswitchedthepatienttoanAurum®1piececolostomypouch5daysaftersurgery.Thepouchwasremovedafter24hoursofwearandtheskinappearedtobeintactwithnoresidueleftonthesurface.

Removingthepouchrequiredminimalforceandthepatientreportedthatthepouchwascomfortabletowear.

Followingafurther24hours,Ichangedthepouchagainandtheskinconditionwasre-assessed.Uponexamination,theskinappearedintactandwithoutanylesions.Iobservedthattheexcessivefluidappearedtohavebeenreduced.

CASE STUDYAurum® withManukahoneycolostomypouch

AnindependentaccountbyDanilaMaculotti,ETNurse

PatientFemale,62,colostomysinceApril2015(rectalcancer)

SourceDanilaMaculotti,ETNurse,PoliambulanzadiBrescia,Italy

ProblemEdematousskin





OUTCOME AND FOLLOW UPTheAurum®pouchwaschangedeverydayandthepatient’sskinconditionbegantoimprove.After14daysonthistreatmentregimethepatient’sskinconditionwasreassessed(Figure2).

Theskinconditionappearedtohavecompletelyhealedwithoutanysignofalterationfollowingthesechangestothepatient’scareroutine.

DIAGNOSIS AND TREATMENTA75yearoldmalewasdiagnosedwithcancerwithinthedescendingtrackofhislargeintestinebeforeundergoingemergencysurgerytoresolveanobstructioninthissection.Thissurgery,carriedouton16thAugust2015,resultedintheformationofapermanentcolostomy.Duringthepost-opperiod,thepatientwasputonacompetitor’s2piecedrainablepouchsystem.

Heexperiencedanegativeskinreactionwhilewearingthispouch;hyperemiclesionswerefoundacrosstheskinallaroundthestoma(Figure1).IusedstomapowderandstomapastetohelpimprovetheconditionoftheskinbutIdidnotobserveanynoticeableimprovements.

Afollowup12dayslatershowedthattheconditionofthepatient’sskinhadstillnotimproved.IdecidedtotryusinganAurum®1piececolostomypouchwithoutanyaccessoriestoseewhataffectthishadonthepatient’sskin.

CASE STUDYAurum® withManukahoneycolostomypouch

AnindependentaccountbyCinziaAsirelli,ETNurse

PatientMale,75,colostomysinceAugust2015(bowelcancer)

SourceCinziaAsirelli,ETNurse,AziendaUSLdellaRomagna-SedediForlì,Italy






OUTCOME AND FOLLOW UPDuringanexaminationon7thMay2015,thepatient’srednesshadbeenreducedandtheskinappearedtobeintact(Figure2).ThepatientremainedontheAurum®pouchandattendedseveralfollowupappointmentstoexaminehisskincondition.Themostrecentwasheldon14thJanuary2016whichshowedtheskintobeintactandwithagoodcolour.

DIAGNOSIS AND TREATMENTA65yearoldmale,diagnosedwithbladdercancer,underwentsurgeryon20thJuly2013toremovehisbladderandformaBrickerurostomy.Followingthesurgery,thepatientwentthroughseveralcyclesofchemotherapy.On10thMarch2014,thepatientpresentedwithrednessonhisperistomalskin.

Wemadeseveralattemptstotreattherednessusingvariouscombinationsofdifferentpouchesandskinprotectorsbutthesewereunsuccessful.On25thMarch2014,thepatientwasputonanothercompetitorpouchandapolyurethanebarrierwasapplied.

Anexaminationon2ndApril2014showedthattherednesshadbeensignificantlyreduced.Thepatientremainedonthispouchuntilhevisiteduson20thJanuary2015,voicingconcernsabouthispouchdetachingandnotfeelingatallsecure.

Wedecidedtoswitchhispouchonceagaintoanothercompetitorproduct;heremainedonthisproductuntil23rdApril2015.Anexaminationonthisdateshowedthattherednesshadreturned(Figure1).ItwasatthispointthatwedecidedtoputthepatientonanAurum®1pieceurostomypouch.

CASE STUDYAurum® withManukahoneyurostomypouch

AnindependentaccountbyLaganà,FalcoandCarmenSerranodeJuan,ETNurses

PatientMale,65,BrickerurostomysinceJune2013(bladdercancer)

SourceElisabettaLaganà,LucianaFalcoandMariadelCarmenSerranodeJuan,ETNurses,OspedaleMartini-Torino,Italy

ProblemSkinrednessanddetachingpouch

TreatmentAurum®withManukahoney1pieceurostomypouch




OUTCOME AND FOLLOW UPThenegativeskinreactionsobservedduringthepatchtestingwerenotpresentoncethepatienthadstartedtousetheAurum®pouch.

Nopicturesweretakenofthepatientaftertheyhadbeguntousehisnewpouches.However,becausethepatientexperiencednonegativereactionsduringthetesting,thedermatologistsandIwerehappyforhimtocontinueusingAurum®pouches.

DIAGNOSIS AND TREATMENTA74yearoldmalewithabilateralurostomyreportedthathehadbeenexperiencinganallergicreactiontothehydrocolloidonhisusualpouch.Idescribedtheconditionofhisperistomalskinasexperiencinga“skinburn”causedbytheHydrocolloid(Figure1andFigure2).I,alongwiththehospital’sdermatologyteam,wantedtoinvestigatethecauseofthisreactionsowestartedbyconductingpatchtests.

WerantestsonsubstancesrecommendedbytheItalianSocietyofAllergologyandDermatologistswhilesimultaneouslytestingforanyreactionstoanAurum®1pieceurostomypouch.Thepatchtestingrevealedthatthepatienthadallergiestomercaptobenzothiazole,dibromodicyanobutaneandoleamidopropyldimethylamine,substanceswhichcanbeusedinadhesives,cosmeticsandwoundcareproducts.

Sectionsofmaterialweretakenfrom3partsofanAurum®pouch:thehydrocolloid,thenon-wovenbackingandtheweldededgesofthebag.Theseweretestedagainstthepatient’sskinforanyreactions.HeexperiencednonegativereactionstothesematerialsandstartedtouseanAurum®1pieceurostomypouch.

CASE STUDYAllergyInvestigation

AnindependentaccountbyMauroBocci,ETNurse

PatientMale,74,bilateralurostomy

SourceMauroBocci,ETNurse,AUSLModena,Italy

ProblemNegativeskinreactioncausedbyskinallergy

TreatmentAurum®withManukahoney1pieceurostomypouch

34 35



Figure1 Figure2

OUTCOME AND FOLLOW UPIdecidedtoprescribeAurum®1piececolostomypouchessoastoavoidanyfurthernegativereactionsandtoallowtheskintimetoheal(Figure2).

DIAGNOSIS AND TREATMENTA77yearoldmalewithacolostomyreportedthathehadbeenexperiencingallergicreactionstoeveryhydrocolloidwithwhichhecameintocontact(Figure1),withtheexceptionofWellandMedical’sAurum®.HewasreferredtoateamofDermatologistswhodecidedtoinvestigatethesereactionsfurther.

Apatchtestwasconductedon18thJanuary2016inordertodiscoverwhatsubstancesmakingcontactwiththeskinwerecausingtheskinreactions.ThesubstancestestedwerelistedbytheItalianSocietyofAllergologyandDermatologistsaspartoftheirstandardallergentests.

ThepatchtestsrevealedthatthepatientwasallergictoMyroxylonPereirae(theBalsamofPeru),whichisusedinsomeplastersforitsadhesiveproperties.

Followingthepatchtest,contacttestsofanAurum®pouchandtwootherpoucheswerecarriedouton25thJanuary.TheresultsindicatedthattheAurum®pouchwasthemostsuitablechoiceforthispatientastheothertwocausednegativereactions,oneofwhichwassignificant.ThepatientalsoexpressedapreferencefortheAurum®pouch’sdesignandcomfort.

CASE STUDYAllergyInvestigation

AnindependentaccountbyMauroBocci,ETNurse

PatientMale,77,colostomy

SourceMauroBocci,ETNurse,AUSLModerna,Italy

ProblemNegativeskinreactionlinkedtoskinallergy


36 37



Figure1 Figure2

38 39

Thehealthandconditionofperistomalskinhasasignificantimpactontheeffectivenessofostomyproducts.Nybæketal.explainthat“theperistomalskinplaysanimportantroleinthefunctioningofthewholepouchingsystem,byprovidingthesurfacetowhichitadheres,andskincomplicationsoftenreducethebase-plates’abilitytoattachtotheskin;thusthequalityofperistomalskinisimportant”3.Anydamagetotheskinsurroundingthesiteofastomacouldreducethesecurityofanostomyproductandincreasethelikelihoodofleakage.AstudybyWooetal.4proposedthat,ofthoseostomatesdiagnosedwithaperistomalskindisorder,77%couldbelinkedtocontactwiththestoma’soutputbutNybæketal.putthefigureataround50%3.Whiletheexactfiguresvary,theconnectionbetweenleakageandperistomalskinhealthisclearlyestablishedinexistingliterature.Meisneretal.arguethatperistomalskincomplicationscancreateacyclewheretheycausetheadhesiveofostomyproductstofail,causingleakage,leadingtofurtherskinproblems5.

Peristomalskincomplicationscancauseawiderangeofsignsandsymptoms,whichcanleadtodiscomfort,pain,poorself-image,socialisolationandimpairedqualityoflife6.TheWorldHealthOrganisationdefinesqualityoflifeas“abroadrangingconceptaffectedinacomplexwaybytheperson’sphysicalhealth,psychologicalstate,levelofindependence,socialrelationships,personalbeliefs”7.Meisneretal.arguethatthefrequencyandseverityofperistomalskincomplicationshasamajoreffectonapatient’squalityoflifeanddailyliving5.BoylesandHuntsupportthis,statingthatcomplicationssuchassoreskinhaveadirectnegativeimpactonhowostomatesviewthemselvesandlivetheirlives1.

ThisstudysetsouttoassesshowsignificanttheintroductionofManukahoneyintohydrocolloidflangesofostomypouchescanbewithregardtobothperistomalskinhealthandanostomate’squalityoflife.

MATERIALS AND METHODSHistoricalrecordsofhoneybeingusedtotreathumanskinconditionsdatebacktotheearliestcivilisations8.ManukahoneyismadeonlyfromthenectaroftheManukaflowerinNewZealandandisknowntoexhibitstrongantibacterialproperties8.ResearchhasshownactiveManukahoneytohavecharacteristicsthatmayhelptokillbacteria,suppressinflammation,andstimulatethegrowthofcells,whichmayaidthehealingprocess.TheManukahoneyusedinthemanufacturingofthetrialpoucheswascertifiedbytheUniqueManukaFactorHoneyAssociation(UMFHA),thegroupresponsiblefortheUniqueManukaFactorQualityMark(UMF).ThisensuresthattheManukahoneyusedisgenuineManukahoneyandmeetsthestandardsrequiredbytheUMFHA,certifyingpurityandconsistency.AllManukahoneyusedinthetrialpoucheshadagradeofUMF16+.

Atotalof336patientstookpartinthestudy:118ofthese(35.12%)hadcolostomies,96(28.57%)hadileostomies,111(33.04%)hadurostomies,10(2.98%)hadnephrostomiesand1(0.3%)hadbothacolostomyandaurostomy.Thisstudy,therefore,incorporatedawiderangeof1-pieceostomypouchtypeswithManukahoneyincorporatedintothehydrocolloidflange.

Theobservationalexaminationoftheuseofthesepoucheswasexecutedacross21differentItalianstomacentresfromMayuntilDecember2015.Duringthestudyenrolment,the336participantswereinformedabouttheirinvolvementandtheirclinicalconditions,thefeaturesoftheirusualpouchesandtheirqualityoflifewasevaluated.Theattendingnursesassessedthehealthoftheparticipants’peristomalskin,recordingaclassificationoftheskin’shealthaswellasthetypeandlocationofanylesionspresent.Aftertwoweeksofusingthetrialpouches,theparticipants’qualityoflifescoreswererecalculatedandtheirclinicalconditionsandthehealthoftheirperistomalskinwerereassessedbythenurses.Eachparticipant’squalityoflifewasevaluatedthroughastomaqualityoflifequestionnairewhichwascompletedatthepointofenrolmentandthencompletedagainafterthetwo-weektrialperiod.

Exclusioncriteriawereestablishedsoastoensurethatpatientswhoseskinconditionsrequiredtreatmentbeyondthatwhichcouldbeprovidedbyanostomypouchandpatientswhoseskinconditionswouldhavebeenalteredbyexternalfactorsorongoingmedicaltreatmentswerenotincluded.

ANALYSIS OF THE IMPROVEMENT TO DAMAGED PERISTOMAL SKIN SEEN WITH THE USE OF POUCHES WITH MANUKA HONEY INCORPORATED INTO THE HYDROCOLLOID FLANGEG.Roveron,PresidentofAIOSS(ItalianStomaNurseAssociation)


OBJECTIVESTheaimofthisstudyistoverifyimprovementsobservedintheperistomalskinconditionwiththeuseofpouchescontainingManukahoneyinthehydrocolloidflangecomparedtoparticipants’usualpouchesandtheeffecttheuseofthesepoucheshasontheirqualityoflife.IfacorrelationisdrawnbetweentheuseofpoucheswithManukahoneyandanimprovement

inperistomalskinhealth,theseresultsmayprovidepotentialrecommendationsforimprovingthehealthofdamagedperistomalskin.Additionally,ifimprovementsinqualityoflifecanbecorrelatedwiththeintroductionofManukahoney,thisstudycouldhelptodeveloprecommendationswhichmayimprovethequalityoflifeofostomatesaffectedbydamagedperistomalskin.

INTRODUCTIONThehealthandconditionofperistomalskinisamajorfactorinpromotingpositiveoutcomesforthoselivingwithstomas1.ResearchbyNybæketal.hasshownthatostomateswhosufferfromperistomalskincomplications(suchas:faecaldermatitis,mechanicaldermatitis,folliculitis,psoriasis,allergiccontactdermatitis,peristomalpyodermagangrenosumandothermoreuncommonconditions)havealessresistantoutermostskinlayer,whichismoresusceptibletodamagecausedbystrippingofadhesivematerials2.Manukahoney,madefromthenectaroftheManukabush(Leptospermumscoparium),wasintroducedintoarangeofhydrocolloidflangesonostomypoucheswiththeintentionthatitmayhelptopromotehealthyperistomalskin.

>>>>>>

Thisarticle,fromWCETJournalVol37No4,isre-printedwiththekindpermissionoftheWorldCouncilofEnterostomalTherapists.

40 41


QUALITY OF LIFEThequalityoflifeofparticipantswasassessedandscoredthroughthecompletionofavalidatedstomaqualityoflifequestionnaire(Stoma-QOL–Italianversion9).Thiscomprises20statementswhichwereputtoeachparticipantandtheywereaskedhowfrequentlyintheirlivestheyfelteachstatementwastrue(Table1)*.Allthestatementswerephrasedsoastohighlightpotentialnegativeaspectsofhavingastoma;somelinkeddirectlytothepouchandstoma,suchasworryingaboutodour,noiseorsecurityoftheadhesive,andsomefocusedonpotentialnegativeinfluencesofhavingastoma,suchaspoorsleepinghabits,restrictingchoicesofclothingorreducingperceptionsofone’sownsexualattractiveness.Thepossibleresponseswere:always(1),sometimes(2),rarely(3)andnever(4).Thescoreslinkedtoeachresponseweretalliedandtheresultingfiguregivesanideaofeachparticipant'soverallqualityoflifeinrelationtotheirstomaatthatparticulartime.Thehigherthefinalscore,thelessaparticipantfeelsthesenegativesareaffectingtheirdailylife.

Participantscompletedthesamestomaqualityoflifequestionnairetwice,oncebeforethetrialbeganandthenagainafterthetwoweekshadcometoanend.Atotalof286participantsfullycompletedbothqualityoflifequestionnaires.Theaveragetotalqualityoflifescoreforthisgroupbeforethetrialbeganwas54.41;afterthe

two-weektrialthisincreasedto59.11(Chart3).Comparingthetotalscoresbeforeandafterthetrialforeachoftheseparticipantsshowsthat26.32%sawtheirqualityoflifescoresincreaseaftercompletingthetrial,62.46%didnotchangeandfor11.23%theirscoredecreased.

52.0

53.0

54.0

55.0

56.0

57.0

58.0

59.0

60.0

54.41

59.11

BEFOREusingpoucheswith

Manukahoney

AFTERusingpoucheswith

Manukahoney

Chart 1: How would you evaluate the condition of your persitomal skin during

the trial?

CONCLUSIONSTheresultsofthisstudyshowthatthemajorityofparticipants,60.99%(n=323),haveseenanimprovementinthehealthandconditionoftheirperistomalskinafterusingthetrialpouchfortwoweeks.Thequalityoflifescoregeneratedbythestomaqualityoflifequestionnaireincreasedfor26.32%ofrespondents(n=286)andthattheaveragescorerose

from54.41to59.11outofamaximumof80.ThiswouldsuggestthattheuseofanostomypouchwithManukahoneyincorporatedinthehydrocolloidflangeoverthistwo-weektrialhadapositiveeffectonthehealthoftheseparticipants’peristomalskinandhadapositiveeffectonthequalityoflifescoregeneratedbythequestionnaireselected.

BEFORE AFTER

Thoseundergoingchemotherapyorradiotherapywereexcludedaswerethosewhoweretakingmedicationfortheirskinbecausethesetreatmentscouldaltertheconditionoftheperistomalskinduringthetrial.

Alloftheparticipantsinvolvedinthisstudywereeithersufferingfromskinproblemsatthestartofthetrialorhadaclinicalhistoryofskinproblemsaffectingtheirperistomalskinareawhichwaslinkedtotheuseofstomacareproducts.Atthestartofthetrial,85%ofparticipants

hadacuteepisodesoftheseproblemsongoing.Theareasurroundingthestomawasbrokenupintofourquadrantstohelprecordthelocationandsizeofperistomalskincomplications.Oftherespondents,55.63%recordedthattheirproblemskinwasinallfourquadrantssurroundingtheirstoma.Thiscouldsuggestthattheissuestheyhavebeenexperiencingwiththeirskinwererelatedtotheflangeofthepouchtheyhadbeenregularlyusingbeforethetrialbegan.

Chart 3: Average quality of life score

WorseImproved NoChange

60.99% 33.75%

5.26%

Chart 2: Compared to your initial situation, how do you evaluate?

Healed WorseImproved NoChange

55.59% 26.97%

5.26%12.17% Figure1:Theperistomalskinofaparticipantbeforethetrial

Figure2:Theperistomalskinofthesameparticipantafterthetrial

RESULTSResponse Rate

Overall,336participantswereinvolvedinthisstudybutnotallparticipantsprovidedananswertoeveryquestionputtothem.Therefore,thenumberofcompleteandvalidresponsestoeachquestion(n)variesandthepercentagescalculatedandincludedinthisreportarebasedonthenumberofvalidresponsesreceivedforeachquestion.

Peristomal Skin

Participantswereaskedtoassesshowtheyfelttheconditionoftheirperistomalskinhadchangedwhilewearingthetrialpouchandweregiventheoptionsofimproved,nochangeandworsened.Oftheparticipants,60.99%(n=323)saidthattheconditionoftheirperistomalskinhadimprovedwhiletheytookpartinthetrial,33.75%feltthattherewasnochangeandtheremaining5.26%feltthatithadbecomeworse(Chart1).Ofthis5.26%,35.29%sawanincreaseinthequalityoflifescoreafterthetrialhadconcluded,11.76%hadaqualityoflifescoreequaltothescoregivenbeforethetrialand50%saidthattheflangewascomfortableduringthetrial.However,64.71%ofthosewhofeltthattheconditionoftheirperistomalskinhadworsenedfeltthattheiroverallsituationhadalsoworsened.Ofthe60.99%whofeltthattheconditionoftheirperistomalskinhadimproved,93.4%ofrespondentsdescribedtheiroverallconditionaseitherhealedorimproved,92.89%feltthatthe

hydrocolloidflangewaseithersecureorverysecureand68.37%sawanincreaseintheirqualityoflifescore.

Leakage

Asignificantinfluenceonthehealthofperistomalskinistheriskofleakage;49.8%(n=255)experiencedleakagewiththeirexistingproducts.Inthetwo-weektrialperiodthiswasreducedto18.64%(n=295).Atotalof84participantsofthisstudyprovidedvalidresponsestobothquestionsonleakage,whichshowedthattheyexperiencedproblemswithleakagewiththeirnormalpouchesbutdidnotwiththetrialpouch.Ofthese,79.52%ofrespondentsdescribedtheiroverallconditionaseitherhealedorimproved,82.14%ofrespondentsfeltthattheconditionoftheirperistomalskinhadimprovedand73.49%ofrespondentssawanincreaseintheirqualityoflifescore.

Perception of Overall Condition

Attheendofthetwo-weektrialperiodparticipantswereaskedhowtheywouldassesstheoverallstatusoftheirstomaandgeneralcondition.Theoptionstheyweregiventoselectwereworsened,notchanged,improvedandhealed.Atotalof304participantsprovidedvalidresponses,12.17%ofthesedescribedtheirconditionas“healed”,55.59%describeditas“improved”,26.97%describeditasnotchangedand5.26%describeditas“worsened”(Chart2).

*Seepage51

42 43

Madefromskinfriendlymaterialusedinwoundcare,UltraFrame®isthethinnestflangeextenderinthemarket.Atonly7micro-metersthick,it’sover140timesthinnerthanthatoftheleadinghydrocolloidbrand.*

CONFORMABILITYConformabilityisameasureofhoweasilyamaterialreactstoforceandadaptsitsshapeaccordingly.Themoreconformableamaterialis,theeasieritwilladapttoextension,compressionandshearwithoutdamage.

Ourtestsconcluded,thatwhenwecomparedUltraFrame®withtwooftheleadingthinfilmwoundcareproductsonthemarket(asaninversefunctionofmeaninflationpressure(mmHg)),UltraFrame®was2.2to3.3timesmoreconformable.*

DISCRETIONUltraFrame®isbarelyvisibleandlesslikelytocomeoffontheedgeandcatchonclothing,givingtheostomatemorefreedomtomovewithoutcompromisingonsecurity.

BREATHABILITYBreathabilityisameasureoftheamountofmoisturethatistransmittedthroughafilmwheninacontactwithasurface.Thisismeasuredbytheamountofmoistureingramstransmittedpersquaredmeterin24hours.

Ourtestsconcluded,thatwhencomparedtothetwooftheleadingthinfilmwoundcareproducts,UltraFrame®is3.5to3.8timesmorebreathable.

THE EVOLUTION OF FLANGE EXTENDERS

THE FUTURE...ULTRAFRAME®

*Dataheldonfile.

SECURITY& LEAKAGE PROBLEMS 142 Itisthethinnest

flangeextenderintheworld

thinnerthantheleadinghydrocolloidbrand

X

X Xmoreconformablethantheleadingthinfilmwoundcareproduct

morebreathablethantheleadingthinfilmwoundcareproduct

Itismadeofthesamematerialusedwidelyinwoundcare

FIVEFACTS

2.2 3.5


Flangeextendersformanintegralpartoftheostomypouchingsystemformanypatients,providingadditionalsecurityduringwearandinparticularduringdemandingandhigh-levelactivities.Securityofapouchwithouttheuseofflangeextenderscanbeinsufficientforsomepatients,inparticulariftheyarepredisposedtoperistomalskincomplications,leakageorirregularskinfolds,whichcancompromiseattachmentandconformabilityoftheflangetotheskin.Theevolutionofflangeextendershasseenthedevelopmentofnovelandhighlydifferentiatingofferingswithsignificantfunctionaladvantages.

WellandMedicallaunchedthefirsteverflangeextender,HydroFrame®in2003andcreatedanewaccessorycategorywithinostomy.Thishydrocolloid-basedproductremainstheflangeextenderofchoiceforalargenumberofostomatesaroundtheworldtoday.Therehavesincebeenseveraldevelopmentsinthisarea,includingthoseutilisingalternativehydrocolloidsandothermaterials.UltraFrame®isoneofthemostrecentflangeextendersfromWellandMedical,exhibitinganultra-thin,highlyconformableandtransparentpolyurethane-basedfilmwithaskin-friendlyacrylic-basedadhesive.

44 45

INTRODUCTIONTheformationofastomamaydiscourageorevenpreventnewostomatesfromresumingtheirpreoperativeactivelifestylesorfrompursuingnewactiveinterests.

Thosewhodotakeupanactivelifestyleaftertheirsurgerywillsubjecttheirostomyproductstomoretestingconditions,throughbending,stretching,sweatingandexposuretowater.Althoughexerciseintroducesadditionalchallengesforostomycareproducts,thisshouldnotpreventthewearerfromtakingpartandbeingactive.Theproductstheyuseneedtobe,therefore,secure,conformable,comfortableanddiscreetenoughtokeepupwiththedemandsoftheiractivelifestyles.

EarlyresearchintotheuseofUltraFrame®flangeextenderrevealedparticularlypositiveresultsfromthosewhoworetheirextenderswhiletakingpartinwhattheythemselvesdescribedas“high-levelactivity”.Theresultsshowedthatthenewproductincreasedsecurity,conformability,comfortanddiscretionfortheseusers.AdditionalactiveostomateswereinvitedtoevaluateUltraFrame®flangeextendertogetabetterunderstandingoftheirneedsandhowtheextendersbeingevaluatedcomparedtocurrentlyestablishedproducts.

MATERIALS AND METHODOLOGYTheagreedexclusioncriterialimitedparticipantstothosewhowerealreadyusingflangeextendersestablishedintheirmarketsandhadnoexistingperistomalskincomplications.OstomatesfromtheUK,DenmarkandSweden,whomettheinclusioncriteria,wereinvitedtotakepart.Atotalof15completedtheevaluation.

Ofthe15,7werebasedintheUK,6inDenmarkand2inSweden.EachcompletedaquestionnairebasedontheirlifestylesandexistingflangeextendersbeforeusingsamplesofUltraFrame®for1week.Theythen

completedasecondquestionnairewhichcomparedtheirexperiencesandopinionsofUltraFrame®withthatoftheirexistingflangeextenders.

Therewerenorestrictionsplacedontheactivitiesinwhichparticipantscouldtakeparttobeincludedinthisgroup;theonlyrequirementwasthattheythemselvesdescribedtheactivitiestheywerecompletingasbeing“highlevel”.EachparticipantwasaskedtolisttheactivitiesinwhichtheytookpartwhilewearingUltraFrame®.Theresponsesincluded,butwerenotlimitedto:runningamarathon,completingatriathlon,running,swimming,cycling,kayaking,hiking,shooting,fishing,Pilates,gardeningandhorseriding.

OBJECTIVESThisstudyaimedtoevaluatetheeffectivenessofUltraFrame®flangeextenderwhenusedbyostomateswithactivelifestyles,bothduringregularday-to-dayuseandduringactivitieswhichtheusersdescribedasbeinghigh-level.

Theusers’perceptionsoftheproduct’ssecurity,conformability,comfortanddiscretionduringtheseactivitieswereofparticularinterestasthesehadbeenidentifiedaskeyprioritiesofostomateswithactivelifestyles.

EVALUATION OF THE PERFORMANCE OF AN ULTRAFRAME® FLANGE EXTENDER IN OSTOMATES WITH ACTIVE LIFESTYLESDrArashMoavenian,HeadofResearchandInnovation

“BEHIND THE SIMPLE FACE OF ULTRAFRAME®, IS A HIGHLY ENGINEERED PRODUCT THAT ADDRESSES THE KEY CONCERNS OF OSTOMATES AROUND SECURITY, DISCRETION AND COMFORT”Dr Arash Moavenian


SECURITYWhenaskedtocomparethesecurityofUltraFrame®withtheirregularproducts,73% felt that UltraFrame® gave them an increased sense of security.Thefullresultswereasfollows:33%feltthatUltraFrame®wassignificantlybetter,40%feltthatitwasbetterandtheremaining27%feltthatitwastothesamestandardastheirexistingflangeextenders.

ParticipantswerealsoaskedtoratethesecurityofUltraFrame®withoutdrawingcomparisontotheirexistingproduct.Onascaleof1(verypoor)to5(excellent),87% rated security 5 (excellent)and13%ratedsecurityas4(verygood).

CONFORMABILITYOfthe15activeevaluators,80% perceived the conformability of UltraFrame® to be of a better quality than the regular flange extenders. Thefullresultswere:47%feltthatUltraFrame®wassignificantlybetter,33%feltthatitwasbetter,13%feltthatitwasthesamestandardandtheremaining7%feltthatitwasworse.

ParticipantswereaskedtoratetheconformabilityofUltraFrame®withoutdrawingcomparisontotheirexistingproduct.Onascaleof1(verypoor)to5(excellent),93% rated the conformability as 5 (excellent)and7%ratedtheconformabilityas4(verygood).

33%

40%

27%

NoChange Better SignificantlyBetter

7%47%

13%

NoChange Better SignificantlyBetterWorse

33%

Conformability out of 5

7%

4/5-VeryGood 5/5-Excellent

93%

Security out of 5

87%

13%


DISCRETIONAtotalof87% felt that the discretion of UltraFrame® was better than their existing flange extenders.Thefullresultswere:54%feltthatthediscretionofUltraFrame®wassignificantlybetter,33%feltthatitwasbetterand13%feltthatitwasthesame.

ParticipantswereaskedtoratethediscretionofUltraFrame®withoutdrawingcomparisontotheirexistingproduct.Onascaleof1(verypoor)to5(excellent),93% rated the discretion as 5 (excellent)and7%rateditas4(verygood).

Discretion out of 5


7%


54%

13%

33%

COMFORTWhencomparingthecomfortofwearingUltraFrame®withthecomforttowhichtheywereaccustomedwiththeirregularflangeextenders,73% felt that the comfort of UltraFrame® was better.Thefullresultswere:46%saidUltraFrame®wassignificantlybetter,27%feltitwasbetterandtheremaining27%feltthatitwastothesamestandard.

46%

27%

27%


CONCLUSIONSInthisevaluation73%ofactiveostomatessaidthattheywoulduseUltraFrame®inplaceoftheirexistingproduct.Themajorityofthosewhotookpartintheevaluationfoundthesecurity,conformability,comfortanddiscretionofUltraFrame®tobetoahighstandard;ineachoftheseareasrespectively:73%,80%,73%and87%ofparticipantsfeltthattheperformanceofUltraFrame®surpassedthatoftheflangeextenderstheywereregularlyusing.ThisdemonstratesastrongcaseforadvocatingtheuseofUltraFrame®forday-to-dayuseandinparticularforostomateswithactivelifestyles.

46

“ULTRAFRAME® IS OVER TEN TIMES THINNER THAN A STRAND OF HAIR AND THE THINNEST FLANGE EXTENDER IN THE WORLD. THIS PROVIDES UNPARALLELED CONFORMABILITY AND COMFORT TO THE USER”Dr Arash Moavenian


Security compared to existing flange extender

Conformability compared to existing flange extender

Discretion compared to existing flange extender

Comfort compared to existing flange extender

93%

47

48

AftersufferingfromUlcerativeColitisfor2years,Jackunderwentsurgerytoformanileostomyattheageof21.Just10monthsafterhisstomawasformed,JackcompletedahalfIronmanandhassincecompetedinthe2017CopenhagenIronman,severaltriathlonsandlongdistancerunningevents.Thisintensivetrainingandactivelifestylehasmeantthathereliesonhisostomycareproductstoremainsecure,conformableandcomfortableunderextremeconditions.

JackwasinvitedtotakepartinanevaluationofUltraFrame®,anultra-thinflangeextender,afewweeksbeforehewasplanningtoruntheFrankfurtMarathon.Here’swhathesaidwhenhespoketoUllaOstenfeld,StomaCareNurse,aftersuccessfullycompletingtherun.

‘IRONMAN’ JACK. LIFE AFTER SURGERY

Whywasyourstomaformed?

Jack: IsufferedfromUlcerativeColitissincetheageof19andafter2yearsoflivingwiththeconditionIcontractedabacterialinfectionwhileonholiday.Ispent5weeksinhospitalafterIunderwent2operationswhichleftmewithanileostomy.Iwasveryweakafterwardsbutquicklybecamebetter.

Doyoualwayswearflangeextenderswhenexercising?

Jack: Yes,apartfromwhenIamonlyrunning5km.

YourinitialresponsetoUltraFrame®didnotseemoverlypositive,whatmadeyoudecidetowearitwhilerunningthemarathon?

Jack:IwasirritatedwiththestiffflangeextenderthatIusedbeforebecauseIcouldfeelitallthetime.Thenthenewflangeextenderpoppedintomymind.Ihadn’treallygivenitafairchancebecauseitseemedcomplicatedwiththe4stepsandIdon’tnormallyusetheinstructionsforuse.IknewmypouchwouldlastthemarathonbutIknewIwouldfeelmoresecurewithaflangeextender.Idecidedtotryitonandwasverypositiveaboutusingitontherun.Iforgotallaboutit,itwasjustthere,andIonlyrememberedIwaswearingitwhenIhadtochangemypouch.

WhatdidyouthinkoftheperformanceofUltraFrame®afteryouhadfinished?

Jack:Verygood.ItfitsintomyscarsandcrevicesandIdon’tfeelthatIhaveiton. >>>

“IT FITS INTO MY SCARS AND CREVICES AND I DON’T FEEL THAT I HAVE IT ON.”Jack


HaveyounoticedtheperformanceofUltraFrame®beingaffectedduringorafterswimming?

Jack: No,itislikeskin.

Aspartoftheevaluationyousaidthatyouneededyourpreviousflangeextendertobemoresecureandcomfortablewhenexercising,hasUltraFrame®addressedthis?

Jack: Absolutely.Ineverusemyoldflangeextenderanymore,itistoostiffandIcanfeelitallthetime.Iacceptedthatthishadtobeapartofwearingaflangeextender.Itwasalsoverydifficulttogetoff.NowIfeelsecureandcan’tfeelthatIhavethenewflangeextenderon.

Whatproblems,ifany,haveyouexperiencedwithyourpreviousflangeextenders,eitherday-to-dayorwhiletrainingandcompeting?

Jack: TheyweretoostiffsoIcouldfeelthemallthetime,theygotstuckinscarsandcrevicesandtheypinchedwhilebendingorstretching.

HowwouldyoucomparetheconformabilityofUltraFrame®withothersyouhaveused?

Jack: Verygood.Itconformstotheskinandyoucan’tfeelit.Theothersyoucanseeandfeel

49

50 51


HowdoyoufeelabouttheupcomingIronman?

Jack: 10monthsaftermysurgeryIcompletedahalfIronmanandthatwentwellbutIknowawholeIronmanwillbeharder.IknowthatphysicallyIwillbeinshapeforitbutmentallyIneedtopreparemyself.Especiallyforthe180kmcyclebeforethe42kmrun.Only50%completethisIronmansoIknowit’sgoingtobehardbutofcourseIwillmanageit.

HaveyoubeenwearingUltraFrame®whiletraining?

Jack: IalwayswearitwhenswimmingandIoftenwearitwhenrunningorcyclingdependingonthedistance.

HowdoyoufeelUltraFrame®hasperformedwhileyouhavebeentraining?

Jack: Itisverygood.It’seasytoputononceyouknowhow.

HasUltraFrame®beenconformable,comfortableandsecureenoughtomeetyourneedswhileexercising?

Jack: BecauseitissothinIwasalittleworriedinthebeginningbutnowIhavenodoubt.Itfitsverywellagainstmyskin.

HaveyoueverhadanoccasionwhereUltraFrame®hasnotkeptupwithyourneedswhileyouhavebeentrainingorcompeting?

Jack:No,IwasspeechlesswhenItrieditduringthemarathon.

HowwouldyoucomparetheconformabilityofUltraFrame®withothersyouhaveused?

Jack: Verygood.Itconformstotheskinandyoucan’tfeelit.Theothersyoucanseeandfeel.

HowwouldyoucomparethesecurityofUltraFrame®withothersyouhaveused?

Jack: Iwasscepticalinthebeginningbecauseitwassothin,butnowIfeelmoresecurebecausethematerialworksonscarsandcrevices.Myoldonewastoostiffandwouldloosenattheedges.

HowwouldyoucomparethediscretionoftheUltraFrame®withothersyouhaveused?

Jack: Ireallylikethatyoucan’tseeit.Itlookslikeskinanditconformstoyourskin.TheothersIhaveusedarevisibleanditlookslikethebaseplateofthepouchisverybig.

InwhichsituationsdoyouthinkUltraFrame®couldmakeadifferenceforothers?

Jack: Tothosewhoexercise,swim,wanttofeelsecureorwanttheirproductstobediscreet.Whynotuseitifyoucan’tfeelitandyouknowitwillmakeyoufeelmoresecure?

P8-P9OstomyChallenges

Claessens,I.,Probert,R.,Tielemans,C.,Steen,A.,Nilsson,C.,DissingAndersen,B.andStørling,Z.M.,2015.TheOstomyLifeStudy:theeverydaychallengesfacedbypeoplelivingwithastomainasnapshot.GastrointestinalNursing,13(5).

Nybæk,H.,Knudsen,D.B.,Laursen,T.N.,Karlsmark,T.andJemec,G.B.,2009.Skinproblemsinostomypatients:acase-controlstudyofriskfactors.Actadermato-venereologica,89(1),pp.64-67.

P12ANaturalBasedHydrocolloidAdhesive

Molan,P.C.,2011.Theevidenceandtherationalefortheuseofhoneyaswounddressing.WoundPracticeandResearch.19(4).

Cooper,R.andGray,D.,2012.Ismanukahoneyacrediblealternativetosilverinwoundcare?WoundsUK,8(4).

Atrott,J.andHenle,T.,2009.Methylglyoxalinmanukahoney—correlationwithantibacterialproperties.CzechJournalofFoodSciences,27(Spec.),pp.S163-S165.

Mavric,E.,Wittmann,S.,Barth,G.andHenle,T.,2008.IdentificationandquantificationofmethylglyoxalasthedominantantibacterialconstituentofManuka(Leptospermumscoparium)honeysfromNewZealand.Molecularnutrition&foodresearch,52(4),pp.483-489.

REFERENCES

Jack Holst wasbornin1993andliveswithhisgirlfriend

inDenmark.Hehashisowncompanyasatradesman.

Ulla OstenfeldisaStomaCareNurseandlivesinDenmark.She

hasover10years’experienceasaStomaCareNurseand

hasservedontheBoardoftheDanishStomaCareNurse

Association,including1yearasitsChair.

P38-P41Roveron,G.,2017.Ananalysisoftheconditionoftheperistomalskinandqualityoflifeinostomatesbeforeandafterusingostomypoucheswithmanukahoney.WorldCouncilofEnterostomalTherapistsJournal,37(4),p.22-25

1.Boyles,A.andHunt,S.,2016.Careandmanagementofastoma:maintainingperistomalskinhealth.BritishJournalofNursing,25(17).

5.Meisner,S.,Lehur,P.A.,Moran,B.,Martins,L.andJemec,G.B.E.,2012.Peristomalskincomplicationsarecommon,expensive,anddifficulttomanage:apopulationbasedcostmodelingstudy.PloSone,7(5),p.e37813.

9.Canova,C.,Giorato,E.,Roveron,G.,Turrini,P.andZanotti,R.,2013.Validationofastoma‐specificqualityoflifequestionnaireinasampleofpatientswithcolostomyorileostomy.ColorectalDisease,15(11).

2.Nybaek,H.,Lophagen,S.,Karlsmark,T.,BangKnudsen,D.andJemec,G.B.E.,2010.Stratumcorneumintegrityasapredictorforperistomalskinproblemsinostomates.BritishJournalofDermatology,162(2),pp.357-361.

6.Jordan,R.andChristian,M.,2013.Understandingperistomalskincomplications.Woundcareadvisor,2(3).

3.Nybæk,H.,Knudsen,D.B.,Laursen,T.N.,Karlsmark,T.andJemec,G.B.,2009.Skinproblemsinostomypatients:acase-controlstudyofriskfactors.Actadermato-venereologica,89(1),pp.64-67.

7.WorldHealthOrganization,1997.WHOQOL:measuringqualityoflife.[Online]Availableat:http://www.who.int/mental_health/media/68.pdf[Accessed17October2017]

4.Woo,K.Y.,Sibbald,R.G.,Ayello,E.A.,Coutts,P.M.andGarde,D.E.,2009.Peristomalskincomplicationsandmanagement.Advancesinskin&woundcare,22(11),pp.522-532.

8.Burlando,B.andCornara,L.,2013.Honeyindermatologyandskincare:areview.Journalofcosmeticdermatology,12(4),pp.306-313.

S-QOL1 IbecomeanxiouswhenthepouchIsfullS-QOL2 IworrythepouchwillloosenS-QOL3 IfeeltheneedtoknowwherethenearesttoiletisS-QOL4 IworrythatthepouchmaysmellS-QOL5 IworryaboutthenoisefromthestomaS-QOL6 IneedrestduringthedayS-QOL7 MystomapouchlimitsthechoiceofclothesthatIcanwearS-QOL8 IfeeltiredduringthedayS-QOL9 MystomamakesmefeelsexuallyunattractiveS-QOL10 IsleepbadlyduringthenightS-QOL11 IworrythatthepouchrustlesS-QOL12 IfeelembarrassedaboutmybodybecauseofmystomaS-QOL13 ItwouldbedifficultformetostayawayfromhomeovernightS-QOL14 ItIsdifficulttohidethefactthatIwearapouchS-QOL15 IworrythatmyconditionisaburdentopeopleclosetomeS-QOL16 IavoidclosephysicalcontactwithmyfriendsS-QOL17 MystomamakesitdifficultformetobewithotherpeopleS-QOL18 IamafraidofmeetingnewpeopleS-QOL19 IfeellonelyevenwhenIamwithotherpeopleS-QOL20 Iworrythatmyfamilyfeelawkwardaroundme

The20statementspresentedtoparticipantswhichmakeuptheStoma-QOL(translatedfromitalian).Participantswereaskedhowfrequentlytheyfeeleachofthesestatementsaretrue,withthepassibleresponsesbeing:always(1),sometimes(2),rarely(3)andnever(4).

Table1.

PID4791

Welland Medical Ltd.,HydehurstLane,Crawley,WestSussexRH109ASUnitedKingdom

©WellandMedical2017•WellandMedicalLtd.isaCliniMed®GroupCompany•Welland®andtheWellandlogoTMaretrademarksofCliniMed(Holdings)Ltd.

Tel:+44(0)1293615455Fax:+44(0)1293615411Email:[email protected]

“WHAT IS NOW PROVED WAS ONCE ONLY IMAGINED.”William Blake

Evidence of innovation - Supplier of Ostomy and Wound Care · the accessories range, where Welland...

Documents

Transcript of Evidence of innovation - Supplier of Ostomy and Wound Care · the accessories range, where Welland...