RSTN Trials Day 2016 Programme v8reconstructivesurgerytrials.net/.../RSTN-Trials-Day-2016-Programme...A systematic review, focus group and international consensus study 20 12. ...

Contents

WELCOME 3

VENUE 3

INTERNETACCESSANDSOCIALMEDIA 3

GOODCLINICALPRACTICE 3

INFORMATIONFORPRESENTERS 4

RECEPTIONATTHETERRACE,SOMERSETHOUSE 4

FUTUREMEETINGS 4

ACKNOWLEDGEMENTS 4

ORGANISINGCOMMITTEE 4

PROGRAMME 5

SPONSORS 8BAAPSAnnualScientificMeeting 9

VIPERS’NESTABSTRACTS 101.CellutomeTMEpidermalHarvestingSystemandReCellTMforVitiligo:ARandomisedControlledClinicalTrial 102.Arandomisedcontroltrialofsimpletrapeziectomyforbaseofthumbosteoarthritiswithplacebosurgeryarm. 113.SUBMIT;StabilityofUnicorticularvsBicorticularMetacarpalInternalFixationTrial 124.Randomisedcontroltrialoftwoversusfourstrandcoresuturerepairofzone2flexortendons 135.CONNECT;CollagentubeNerveapproximationversusNeurorrhaphy-EvaluationofClinicalOutcomeTrial 146.RandomisedClinicalTrialEvaluatingtheEffectofQuiltingSuturesinLengthofHospitalStayandSeromaRateinDIEPBreastReconstruction 157.TheNEWStrial:NeutralvsExtendedWristSplintageforzoneI/IIflexortendoninjuries 168.ComparingFullThicknessSkinGraftLossRatesUsingFibrinGlueversusTie-OverTechniqueinElectiveSkinCancerPatients(GLUE)Trial 179.Autologousfattransferandcompplicationratespostimplantbasedbreastreconstruction 1810.STOPNEUROMA:SurgicalTreatmentOfsymPtomaticNEUROMA 1911.Whatcoreoutcomesshouldbereportedinclinicalresearchandinhealthcareforpatientswithcraniosynostosis?Asystematicreview,focusgroupandinternationalconsensusstudy 2012.SkinPreparationforOperativeTraumaOfthehaNd(SPOTON) 2113.Whatistheoptimaltimetostartadanglingregimeafterfreeflapreconstructionofthelowerlimb 2214.VivostatandReCellforAdultBurnSplit-thicknessSkinGrafting:ARandomisedControlledClinicalTrial 2315.FifthMetacarpalBaseInjuryOutcomesTrial 24

WelcomeWelcometothefourthRSTNTrialsDay.WeareverypleasedtobejoinedbyanumberofdelegatesfromTheNetherlands.JustastheUKiscontemplatingBrexit,theRSTNistryingtobuildcloserinternationallinks,especiallywithEuropeanresearchnetworks.

ThelastyearhasdemonstratedthepowerofhavingaUKwidenetwork.ProjectsincludingtheRSTN/BSSHTraumaAudit,MALIT,iBRAandtheWIREhaveexceededexpectationsinthetermsofengagingunits,collaboratorsandthedatacollected.

Wehopeyouenjoythedayandthatitinspiresyoutogetinvolvedincollaborativeclinicalresearchandconsiderdevelopinganideaofyourown.

WeareverygratefultotheRCS,BAPRAS,BSSHandoursponsorsformakingthedaypossible.TheeventisaccreditedbytheRoyalCollegeofSurgeonsofEnglandforupto6.0CPDpoints.Certificateswillbeprovidedoncompletionoftheelectronicfeedbackform,whichyouwillreceivebyemailfollowingtheevent.

VenueRoyalCollegeofSurgeonsofEngland,35-43Lincoln’sInnFields,WC2A3PE.

Registration MainfoyerMainconferenceroom CouncilRoom/LectureTheatre2Refreshmentsandsponsors Councilroomandcommitteerooms1+2

Thecloakroomisinthebasement.

InternetaccessandsocialmediaFreeWifiisavailableusingtheRCS-PUBLICnetwork.Togetconnected,openabrowserwindowandacceptthetermsandconditions.

FollowusonTwitter:@Surgery_Trials #RSTN2016#plasticsurgery

InteractivesessionswillusePollEverywhere.Therearethreewaystocomment:

1.Openbrowserandgotopollev.com/rstn.

2.Tweetyourquestions/commentsto@Surgery_Trials

3.TextRSTNto02033225822(costatyournetworkrate)tojointheconversation

ThedayisbeingbroadcastliveonPeriscope(downloadAppleorAndroidApp)

GoodClinicalPracticeTheNIHRprovidesfreeonlinetrainingathttp://learning.nihr.ac.uk/learning/.RegisterandthenrequesttheGCPtrainingmodule.ItisessentialtohaveaGCPcertificatetobeinvolvedinclinicalresearch.

InformationforpresentersPleaseuploadyourtalktothePCinlecturetheatre2.Thiswillbeavailablefrom0900onthedayandduringthebreaks.Useofapersonallaptopwillnotbepossible.

ReceptionattheTerrace,SomersetHouseStraightafterthemeetingweareheadingtoTom’sTerraceatSomersetHouse.Ticketsare£20andincludedrinksandbarfood.TheycanbeboughtonthedayfromNaghamDarhouse.Noticket,noentry!

FuturemeetingsNov2016 RSTNSession@BAPRASWinterScientificMeeting2016

30/11/2016 NationalResearchCollaborativeMeeting2017,RCSLondon

June2017 RSTNTrialsDay2017

AcknowledgementsTheRSTNissupportedbyBAPRASandtheBSSHaspartoftheRCSclinicaltrialsinitiative.WearegratefultotheRoyalCollegeofSurgeonsofEnglandforhostingtheeventandMuratAkkulak,ResearchCoordinator,forhisassistance.WewouldalsoliketothanktheOxfordandBristolandYorkSurgicalTrialsUnitsfortheircontributiontothemeeting.

WearegratefulforthesupportofQMedical,SmithandNephew,Nagor,Mentor,OxfordUniversityPress,Ethicon,StratticeandCCRExpo.Furtherdetailsareavailableinthesponsorshipsection.

OrganisingcommitteeAnnaAllan,NaghamDarhouse,MattGardiner,JayPancholi,BenWay,KatieYoung

Programme

0900 Registration(REFRESHMENTSAVAILABLE)

0930 WelcomeintheCouncilRoom

Prof.AbhilashJain,SurgicalSpecialtyLeadforPlasticSurgeryandHandSurgery

Sessionone:developingatrialidea

0940 SandpitSessionintheCouncilRoom

Prof.DavidBeard,ProfessorofMusculoskeletalSciencesandCo-DirectorofRCSSurgicalInterventionalTrialsUnit(SITU),Oxford

Aims:

1.Learnhowtosetaresearchquestion2.UsePICOtodevelopatrialidea3.Understandwhatinfluencesthetrialdesign

1100 REFRESHMENTS,NETWORKINGANDVIPERS’NESTPOSTERS

Sessiontwo:trialdeliveryandmethodologyLectureTheatre2

1130 Areyouinorout?DevelopingEuropeanclinicaltrialcollaborations

HinneRakhorst,ConsultantPlasticSurgeon,Netherlands

1145 Soyouwanttobeaprincipalinvestigator?

RichardPinder,ConsultantPlasticSurgeonandPIforNINJA

1200 Recruitment,recruitment,recruitment:keyissuestoconsider

Prof.JaneBlazeby,ProfessorofSurgery,BristolSurgicalTrialsCentre,Bristol

1300 LUNCH,NETWORKINGANDVIPERS’NESTPOSTERS

Sessionthree:ResultsandupdatesonRSTNsupportedprojectsLectureTheatre2

1400 Whatdoesasurgicaltrialsunitoffer?

Prof.DavidTorgerson,DirectorYorkTrialsUnit

1420 WIRETrial–toburyornotburyKwiresfollowingfracturefixation.

SonyaGardineronbehalfoftheWIRECollaborative

1430 MALIT–splintingformalletinjuries.Resultsofanationalcliniciansurvey.

ZoeTolkeinonbehalfoftheMALITCollaborative

1440 optiFLAPP–optimisingperioperativecareinmicrovascularbreastreconstruction.

LukeGeogheganonbehalfoftheoptiFLAPPCollaborative

1450 AnupdateontheBSSH/RSTNhandtraumaaudit.

MattGardineronbehalfoftheBSSHTraumaCollaborative

1500 iBRA2-immediatebreastreconstructionandadjuvanttherapy.

MarieKearnsonbehalfoftheiBRA2Collaborative

1505 TEAM-ThErApeuticMammoplastyAudit.

ShelleyPotter,ClinicalLecturerinBreastSurgery

1515 REFRESHMENTS,NETWORKINGANDVIPERS’NESTPOSTERS

Sessionfour:Vipers’Nest–newtrialideasLectureTheatre2

1545

STOPNEUROMA:SurgicalTreatmentOfsymPtomaticNEUROMA

MariettaBertleff,Netherlands

1600

ComparingFullThicknessSkinGraftLossRatesUsingFibrinGlueversusTie-OverTechniqueinElectiveSkinCancerPatients(GLUE)Trial

TheodorePezas,Oxford

1615

SUBMIT;StabilityofUnicorticularvsBicorticularMetacarpalInternalFixationTrial

BafiqNizar,FeiranWu,KatieYoung,RajivJose,MarkFoster,Birmingham

1630 VivostatandReCellforAdultBurnSplit-thicknessSkinGrafting:ARandomisedControlledClinicalTrial

JustinWormald,DeclanCollins,ZaidAlqalaf,IsabelJones,JoanneAtkins,London

1700 Closeofmeeting

Certificateswillbeawardedonreceiptoftheelectronicfeedbackformsthatwillbedistributedaftertheevent.

SponsorsWearegratefulforthesupportofthefollowingcompanies.

QMedicalTechnologiesLtdanindependentUKcompanyfoundedin2004.QMedicaldistributesandmarketsSurgiMendPRS-forplasticandreconstructivesurgeryaswellasPolytechBreastImplantsthatcomeswiththemostextensivewarrantycovertoprotectyouandyourpatient.Developedtomeetthespecificneedsofplasticsurgeons.

Ethiconremainthegloballeaderforsutures.ContinuinginnovationhasledtothedevelopmentofStratafix,abarbedsuture.Itimprovesscarcosmesis.

Mentorisaleading,globalmanufacturerofhighqualitybreastimplantsforbothreconstructiveandaugmentationprocedures.

Healthcare 21 are delighted to be a Corporate Sponsor of this international conference. On display at our booth will be the Lifecell® regenerative medicine portfolio. Healthcare 21 are Acelity’s exclusive sales and marketing partner for Lifecell® products in the UK, Ireland, Germany and Austria.

Established in 2003, we are one of the UK and Ireland’s largest privately owned healthcare companies.

Smith&NephewAdvancedWoundManagementprovideshighqualityproducts,medicaleducationandservicessupportinginitialwoundbedpreparationthroughtofullwoundclosure,enablingbetteroutcomesforpatientsandhealthcaresystems.

OUPisaleadingglobalpublisherwithanextensiveplasticandreconstructivesurgerycatalogue.ItalsopublishestheAestheticSurgeryJournal.

BAAPSAnnualScientificMeeting

TheBritishAssociationofAestheticPlasticSurgeonsAnnualScientificMeetingandTraineeProgrammewilltakeplaceonsiteattheCCRExpothisOctober6-7inLondon.

Alltraineeandconsultantsurgeonsareinvitedtoattendfortwodayspackedwithpresentationsfromworldexpertsinthefieldofaestheticsurgery.

Hearpracticaltalksbyexpertsoncommonprocedures,trainingopportunities,updatesontheconsentprocessandstrategiesformanagingdifficultsituationsincosmeticsurgery.

SurgeonswhohaverecentlybeenappointedtoaConsultantpostarealsowelcometosharetheirexperienceofstartinganaestheticpractice.

Supportedbytheworld’smostprominentindustrybodiesCCRExpofeatureshighqualityCPDcertifiededucationalcontentandadefinitiveexhibitionoftheleadingsurgicalandnon-surgicalproductsandservices.

Findoutmoreathttp://www.ccr-expo.com/baaps-annual-meeting

Vipers’NestAbstractsTherearetwoprizes,onefortheoralpresentationsandonefortheposters.TheywillbescoredbysurgicaltrialsmethodologistsAKA‘theVipers’.

Thewinnerswillreceiveacertificate,entertheVipers’NestofFame,receiveacopyof“Surgery,theUltimatePlacebo:ASurgeonCutsThroughtheEvidence”anda£50booktokenfromOUP.

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1.CellutomeTMEpidermalHarvestingSystemandReCellTMforVitiligo:ARandomisedControlledClinicalTrial

DeclanCollins,JustinWormald,IsabelJones,TonyMetcalfe,SarahDiazVitiligoisacommonautoimmunepigmentationdisorderwithaworldwideprevalenceof0.4to2.0%,withgreaterprevalenceinfemalesand50%onsetinchildhood.ConventionaltherapyiswithtopicalsteroidsandUVlight.Surgicaltreatmentisindicatedoncemedicaltherapyhasfailedandthediseaseprocesshasstabilised.Severalstudieshavedemonstratedsuccessfuluseofepidermalskingraftingusingsuctionblistersinpigmentationdisorders.Despitethis,levelIevidenceislacking.WeproposearandomisedcontrolledclinicaltrialoftheCellutomeTMEpidermalHarvestingSystem,aminimallyinvasivetoolforharvestinganepidermalmicrograftwithandwithoutReCellTM,anautologousnon-culturedcelltherapycomparedtoconventionalmedicaltherapyforstablevitiligo.Participants:Adultpatients>18yearsoldwithaprimarydiagnosisofstableautoimmunevitiligo(notactivedisease)InterventionIntervention1:CellutomeTMIntervention2:CellutomeTMplusReCellTMControlConventionalmedicaltherapyOutcomes(measures):Clinical:percentagerepigmentation(digitalphotographs),globalassessmentofthedisease(VAS),maintenanceofrepigmentation(digitalphotographatfollow-up),stabilityofdisease(VitiligoIndexDiseaseActivityscore)Patientrelatedoutcomemeasure:Skindex-29–avalidatedqualityoflifequestionnaireforskindisease,cosmeticacceptabilityofresults(VAS)Basicscience:melanocyteviabilityofCellutomeTMandRecellTMatpointofgraftandposthealinganalysisbypunchbiopsytoconfirmestablishedmelanocytepopulation.(BlondMcIndoe)

2.Arandomisedcontroltrialofsimpletrapeziectomyforbaseofthumbosteoarthritiswithplacebosurgeryarm.

KamalathevanP,CooperC,VincentT,BeardD,JainA,GardinerMDOxfordBaseofthumbosteoarthritisisacommoncauseofpainanddisability.Morethan3000trapeziectomiesareperformedannuallyintheUKtotreatadvanceddisease.TherecentCochranereview(Wajon2015)recommendedsimpletrapeziectomybutconcluded,“Weareuncertainifanysurgeryhasbenefitscomparedtonosurgery,non-surgicaltherapiesorshamsurgeryasnostudieswerefoundassessingthesecomparisons.”High-qualityevidencetosupporttheeffectivenessofsimpletrapeziectomyislacking.Publishedseriesreportcomplicationratesof25%andcontinuedpainin30%patientsfollowingsurgery.Thereisevidencethatmanypatientsbenefitfromcontinuednon-surgicaltreatment.Theremaybemanypatientshavingunnecessarysurgery.Population:adultpatientsage>50withpainandradiographicOAIntervention:simpletrapeziectomyComparators:placebosurgery,continuingnon-operativemanagement(e.g.splinting)Primaryoutcome:AUSCAN12months

3.SUBMIT;StabilityofUnicorticularvsBicorticularMetacarpalInternalFixationTrialBafiqNizar,FeiranWu,KatieYoung,RajivJose,MarkFoster

BirminghamHandCentre,UniversityHospitalsBirminghamNHSFoundationTrust.PopulationPatientspresentingwithanopenorclosedmetacarpaldiaphysealfracturethatrequireastraightplatefixationovertheageof16arerecruitedandrandomisedintothetrialfromJune2015overaperiodof3years.InterventionFollowingreductionofthefractureaunicorticularfixationisundertaken.Intra-operativefluoroscopyisusedtoconfirmsatisfactoryreduction,plateandscrewposition.ControlThisgroupwillhaveabicorticularfixationandscreenedunderfluoroscopy.OutcomeTheprimaryoutcomeisradiologicevidenceoffracturehealingat6monthtimepoint.Secondaryoutcomesmeasureswillinclude,theDisabilitiesoftheArm,ShoulderandHand(DASH)score,Visualanaloguescore(VAS)forpainmovementfunctionandsatisfactionandtheEQ5D.Patientsarefollowedupat2week,6weekand6monthtimepoints.

4.Randomisedcontroltrialoftwoversusfourstrandcoresuturerepairofzone2flexortendons

BafiqNizar,MarkFoster,DominicPower,RajivJoseBirminghamHandCentre,UniversityHospitalsBirminghamNHSFoundationTrust.PopulationPatientspresentingwithfresh(lessthan7days)openwoundstothehandwithaclinicalsuspicionofazone2flexortendonlesionwillbescreened.Patientsconsentingtothetrialwillundergofurtherintra-operativeassessmentforeligibilityandonconfirmationofaflexordigitorumprofundus,flexordigitorumsuperficialisorflexorpolicislongustendonlesionitwillberandomisedtothetrial.InterventionFollowingexposureoftheinjuredtendonatwostrandcoresuturerepairwillbeundertakenunderloupemagnificationfollowedbyanepitendinousrepair.Repairtechniqueandsuturematerialwilldependonsurgeonpreference.Theywillbesplintedandreferredtothehandtherapistforearlyactivemobilisationprotocol.ControlThecontrolarmwillundergoafourstrandcoresuturerepairandfollowthesamemobilisationregimeastheinterventiongroup.OutcomeTheprimaryoutcomemeasureistherateoftendonruptureatthreemonthfollowupappointment.Secondaryoutcomesmeasureswillincludetotalactivemotion(TAM),theDisabilitiesoftheArm,ShoulderandHand(DASH)score,VisualanalogueScore(VAS)forpain,stiffnessandfunctionandtheEQ5D.Rateofcomplicationsandre-operationrateswillalsobemeasured.

5.CONNECT;CollagentubeNerveapproximationversusNeurorrhaphy-EvaluationofClinicalOutcomeTrial

BafiqNizar,SuzanneBeale,CarolineMiller,MarkFoster,DominicPowerBirminghamHandCentre,UniversityHospitalsBirminghamNHSFoundationTrust.PopulationPatientspresentingtothePlasticsurgery/Handsurgerytraumaunitwithfresh(lessthan5days)openhandwoundswithaclinicallysuspicioustraumaticsensorynervelesionwillundergopre-operativescreening.Onceconsented,theywillundergofurtherintra-operativeassessmentforeligibility.Onconfirmationofacompletelesiontoasensorynerve,eachnervewillberandomisedtobeincludedinonearmofthetrial.InterventionFollowingexposure,acollagennerveconnectorofappropriatedimensionswillbechosenandsoakedinsalinefor10minutes.Nextitwillbeplacedovertheproximalnervestumpandretractedawayfromthetransectionsite.Thenerverepairwillbecompletedundertheoperatingmicroscopeusinginterruptedepineuralsuturessize9-0.Followingrepairthenerveconnectorwillbepositionedoverthesuturesiteandsecuredwithasingle9-0sutureateachendoftheconnectorontotheadjacentepineurium.ControlThisnervegroupwillberepairedusingastandardmicroscopeassistedinterruptedepineural9-0suturetechnique.OutcomeTheprimaryoutcomeisameasureofsensoryrecoveryusingstaticandmovingtwo-pointdiscrimination(tactilegnosis)usingastandardisedprotocol.Secondaryoutcomesmeasureswillincludemonofilamentpressurethresholds,theDisabilitiesoftheArm,ShoulderandHand(DASH)score,theEQ5D,differentialTinel’ssign,andvisualanaloguescales(VAS)forpain,coldintoleranceandhyperaesthesia.

6.RandomisedClinicalTrialEvaluatingtheEffectofQuiltingSuturesinLengthofHospitalStayandSeromaRateinDIEPBreastReconstruction

CynthiaTsangProlongedabdominaldrainageafterDIEPbreastreconstructionisacommonproblem,resultinginpatientmorbidity,prolongedhospitalstayandseromaformation.Quiltingoftheanteriorabdominalwallhasbeeneffectiveinreducingdrainageinabdominoplastypatients1,2,3,4.Thecostofsuturematerial,additionalproceduraltimeandthelearningcurverequiredformasteryoftechniquemaybefavourablyoff-setbyimprovedpatientrecovery,reducedlengthofstayandreducedrateofseromaformationrequiringaspiration.Theresearchquestionisoutlinedbelow:ForpatientsundergoingDIEPbreastreconstruction,isquiltingoftheanteriorabdominalwallmoreeffectivethannoquiltingforreducingseromarateandlengthofstay?P PatientsundergoingDIEPbreastreconstructionI QuiltingofabdominaldonorsiteC NoquiltingO Primaryoutcome: Abdominaldrainage(totalvolumeuntilremovalofdrains)LengthofHospitalStay(days)SeromaRate(%requiringaspiration)Secondaryoutcome: Complication(skindimpling,skinnecrosis,haematoma)PatientSatisfactionQuiltingtoeliminatedeadspace,reducingseromaformationiswidelyacceptedandadopted,suchasinthecontextofLatissimusDorsidonorsiteclosure.However,thepracticeofquiltingintheabdominaldonorsiteforDIEPreconstructionisvariable.Acaseseriescomparing53patientsundergoingDIEPreconstructionshowedasignificantreductionintotalabdominaldrainagewiththeuseofquilting(seetablebelow)5.ThereiscurrentlynolevelIevidencethataddressesthisclinicallyrelevantquestion. TotalDrainage(ml) LengthofStay(days)

Quilting 238.31 8.53

NoQuilting 527.78 9.11

p=0.0005 p=0.401

7.TheNEWStrial:NeutralvsExtendedWristSplintageforzoneI/IIflexortendoninjuries

JBarnes,RJeevan,MGardiner,NBurr,DKennedy,AJain,AIqbalTheevolutionofflexortendonrehabilitationregimesoverthelast40yearshasbeenfocusedonoptimisingthebalancebetweenimmobilisationtoreducetheriskofruptureandmobilisationtoreducetheriskofadhesionatkeytimesduringthehealingprocess.Timingofactiveandpassivemotionaswellassplintpositionhavebeenmodifiedovertheyearsbasedonsurgeonandtherapistexperience,smallscalebiomechanicalstudiesandlimited,quasi-experimental,clinicaldata.Wristpositionhasbeenproposedasapotentiallyusefulvariableformanipulation.Anextendedwristpositionincreasestherestingleveloftensionacrossarepairwhilereducingtheadditionalforceneededtoachieveactiveflexionandimprovingexcursion.Inthecontextofstronger4strandrepairsreplacingtraditional2strandtechniquesithasbeenproposedthatanextendedwristpositionmayhaveadvantagesoveraneutralwristpositionwhichismostoftenused.WeproposeaRandomisedControlledTrialinvestigatingwristsplintpositioninzoneI/IIflexortendoninjuries.ThepatientpopulationwouldincludesadultpatientswithZoneI/IIflexortendoninjuriesundergoingprimaryrepairwithoutunderlyingfracturesoraneedforrevascularization.Theinterventionissplintagewithanextendedwristpositionaspartofthenormaltherapyregime.Thecontrolgroupwillbesplintedwithaneutralwristpositionwithanotherwiseidenticalrehabilitationregime.TheprimaryoutcomemeasureisTotalActiveMotionwhilesecondaryoutcomemeasuresincluderuptureandadhesionrates,comfort,gripstrength,patient-reportedfunctionaloutcomesandactivitiesofdailyliving.

8.ComparingFullThicknessSkinGraftLossRatesUsingFibrinGlueversusTie-OverTechniqueinElectiveSkinCancerPatients(GLUE)Trial

TheodorePezasOxfordUniversityHospitalsNHSFoundationTrustBackgroundandAims:Securingfullthicknessskingrafts(FTSGs)hastraditionallyinvolveduseofatie-overtechniquewherebyabolster-typedressingisanchoredtothegraftedareawithcircumferentialnon-absorbablesutures.Althoughthisisgenerallythoughttoencourageimbibitionbyenforcingadequatecontactofthegraftwiththerecipientsite,severalstudiesrevealthatthismayleadtoincreasedtissuetrauma,patientdiscomfortandaprolongmentofsurgicaloperatingtimes.Useoffibringluetosecuresplitthicknessskingraftinghasnowbecomeroutinepracticeinburnssurgery.Thereiscurrentlynohigh-levelevidencetocompareuseoftie-overtechniquetofibringluealonetosecurefullthicknessskingraftsinelectiveskinreconstructivesurgery.Methods:Amulti-centrerandomisedcontrolledtrialisproposed.Theplanwillbetoenlistcollaboratorstoenrollpatientsaged60+undergoingelectivereconstructionusingfullthicknessskingraftingfollowingskincancer(BCCandSCC)excision.PatientswillberandomisedtohavetheirFTSGstied-overorgluedandthenreviewedat5,12and19dayspost-graftingtoassesstake.Results:CollecteddatawillbeuploadedusingRedCaptoensurecontemporaneousdatacapture.Statisticalanalysiswillthenbeperformedtomeasureprimary(grafttake)andsecondaryoutcomes(patientpreference,surgeonpreference,operativetime,cost).Conclusions:Decidinghowtosecurefullthicknessskingraftsfollowingelectivereconstructionpost-skincancerexcisionhasimplicationsforpatients,surgeonsandhospitals.Thereiscurrentlynohighqualityevidencetocomparetie-overtechniquetofibringluealoneforsecuringfullthicknessgrafts.SIMPLIFIEDPICOFORMATP: 60+maleandfemalepatientsundergoingFTSGreconstructionpost-skincancer(BCCorSCC)excisionI: FibringluetosecuregrafttobedC: Conventionaltie-overtechniquetosecuregrafttobedO: Primary:Grafttake;Secondary:patientpreference,surgeonpreference,operativetime,cost

9.Autologousfattransferandcompplicationratespostimplantbasedbreastreconstruction

LopaPatelLipomodellinghasonlybecometechnicallyrefinedandsafeinthelast20yearsandthereiscurrentlyapaucityoflong-termoutcomedata.Adiposederivedregenerativestemcells(ADRCs)maybeoftherapeuticvaluebyreducingcapsularcontractureratesinimplantbasedreconstructionsandgivingrisetobetteraestheticaloutcomes.Theoveralldemandandexpectationofanaestheticallymindedreconstructionhasmeantthatincreasinglybreastconservingsurgeryisperformedmorefrequently.Inturnthishasmeantthatlipofillingisanincreasinglyamenabletechniquetocorrectorreconstructontologicallyresecteddefects.Howeverthereisalackofanylongtermpatientrelatedoutcomedataassessingthisprocedure’sefficacy.WeproposeaprospectivemulticentreUKbasedtrialtakingplaceover12to18monthsexaminingtheeffectofautologousfattransferonpatientswithimplantbasedreconstructionpostradiotherapy.Participantsincludeanywomenovertheageof18upto70whohavehadradiotherapy.Halfoftherecruitedpatientpopulationwillundergorandomisationforlipofillingpre-implantinsertionandthecomparativestandardwillbeimplantreconstructionalone.Primaryoutcomewillincludefrequencyofcomplicationsandre-procedurerate.Secondaryoutcomeswillassessa)inpatienthospitalstayperiodcomparisonforbothproceduresb)aestheticevaluationofreconstructionandc)qualityoflifeassessedviaavalidatedquestionnairesuchasBreastQassessedat6,12and18monthspostprocedure.Astatisticalcomparisonoftheseresultswillhelpdelineateefficacyoflipomodellinginradiotherapyimplantbasedreconstructionforreducingrisksandimprovingpatientoutcomes.

10.STOPNEUROMA:SurgicalTreatmentOfsymPtomaticNEUROMA

MariettaBertleffNetherlandsSymptomaticneuromamaydevelopafteranervedissectionfollowinganytraumatoaperipheralnerve.Neuroma-inducedneuropathicpainandmorbidityseriouslyaffectspatient’sdailylifeandsocioeconomicfunctioning.Theincidenceofsymptomaticneuromasafterperipheralnerveinjuryisestimatedtobe3-5%,howevercertainsurgeries(autograftprocedures,amputations)mayhaveuptoa30%incidencerate.Thereareseveralsurgicalprocedurespossibletotreatsymptomaticend-neuromas,butnoneareconsideredgoldstandardforbothtreatmentandprevention.Themostcommonprocedureissurgicalremovaloftheneuromaandsurroundingscartissueandplacingtheproximalstumpintoanareasubjectedtominimalmechanicalstimulation.Unfortunately,patientswithsymptomaticneuromashadanaverageof2.8re-operationstotreatpainandthesurgerieshaveafailurerateof10%ormore.Aresorbablepoly-DL-lactide-caprolactonenervecappingdevicehasbeendevelopedfortreatmentofneuromas.Bydevelopingaconduitwithaclosedend(cap)itisexpectedthattheamountofaxonalsproutingisloweredduetothefactthatneurotrophichormonescannoteasyreachthenervestump.Alsothematerialisknownforformationofathinorganizedfibroticlayeraroundthecapwhichlowerstheriskofadhesionofthenervestumpinscartissue.AprospectiveEuropeanmulticentre,nonrandomisedtrialhasbeenstartedinwhichpatientswithprimaryofsecondaryend-neuromaoftheupperlimbareenrolled.FollowupwillbeoneyearandthestudywillbeguidedbyMD-Clinicals.

11.Whatcoreoutcomesshouldbereportedinclinicalresearchandinhealthcareforpatientswithcraniosynostosis?Asystematicreview,focusgroupandinternationalconsensusstudy

ThomasEdwardPidgeona,Mark-AlexanderSujanba)St.AndrewsCentreforPlasticSurgeryandBurns,BroomfieldHospital,Chelmsford,Essex,CM17ET,UK.b)AssociateProfessor,WarwickMedicalSchool,UniversityofWarwickBackgroundCraniosynostosisisacommoncraniofacialconditionwithanincidenceof1in1500-2000livebirths.Variableoutcomereportingexistswithincraniofacialsurgery,whichcouldpotentiallyleadtodataheterogeneity,thepreventionofcomparisonsbetweenstudiesandpoorconsensusonmanagement.VariableoutcomereportingcanbeaddressedwiththeadoptionofaCoreOutcomeSet(COS),butatpresentnoneexistsforcraniosynostosis.AimIdentifyacoreoutcomesetthatshouldbereportedinallfutureclinicalresearchandinthehealthcareofpatientswithcraniosynostosisMethodsThisstudywillreviewtherelevantliteratureusingaCochrane,AMSTARandPRISMAcompliantsystematicreview.Thiswillsummarisewhatoutcomesarereportedinstudieswhereaninterventionisusedtotreatcraniosynostosis,andhowtheseoutcomesaredefined.Itwillsubsequentlydiscussthesefindingswithclinicalandlayfocusgroupstoexplorewhatoutcomesbothcliniciansandthepublicfeelareimportantwhenwetreatcraniosynostosis.Finally,aninternationalonlinesurveywillbecirculatedtocraniofacialmultidisciplinaryteamsworldwidetoidentifyoutcomesthataremosthighlyvaluedbytheinternationalcraniofacialcarecommunity.HowtheRSTNcanhelpThefinalstepofthisworkrequiresinternationalcollaborationwithcraniofacialunitsworldwide.TheReconstructiveSurgeryTrialsNetwork(RSTN)providesanidealplatformonwhichtodevelopanetworkofcollaboratingcraniofacialunits.Intime,anindependentworldwidecraniofacialcollaborativemayform.TheinternationaladoptionofanagreedCOSincraniofacialsurgerywillunifyallfutureclinicaltrialstoensuretheyarecomparable.

12.SkinPreparationforOperativeTraumaOfthehaNd(SPOTON)

CobbW,DingleL,ZarbAdamiR,RodriguesJOxfordTherearearound20122openhandtraumaepisodesayearinEngland[2003HESdata],97%ofwhichrequireadmission.Assumingpostoperativeinfectionincidenceis0.5%,1006infectionsoccurannually.Thecostofinfectionsarereportedas£1170-£3400/infection[Graves2001].Totalcostofpostoperativehandtraumainfectionsmaybe>£3.4million.Aqueousskinpreparationsarecommonlyusedtominimisesurgicalsiteinfection(SSI),withchlorhexidinegluconate(CHG)orpovidone-iodine(PVP-I)asactiveagents.NICEguidelineCG74recommendsusingeither,andbotharewidelyavailable,suggestingclinicalequipoise.Uncertaintypersistsduetopaucityandinadequacyofprevioustrialsbasedonoursystematicreview.Weproposeapragmaticmulti-centreRCT:PopulationAdultpatients(>16years)withisolatedopentraumatichand/forearmwoundsundergoingprimarysurgicalintervention.Patientswhoreceiveprophylacticantibioticswillbeincluded,andasubgroupanalysisperformed.Clinicallyinfectedwounds(includingosteomyelitis),thoseundergoingmulti-sitesurgeryinadditiontothehand(e.g.polytraumapatients)andpatientswithhypersensitivitytoagentswillbeexcluded.InterventionPreoperativeskinpreparationwithaqueousCHG.Woundswabswillbetakenpriortosurgicalintervention.Randomisationwillbeperformedintheatreimmediatelypriortoskinpreparation.ComparatorPreoperativeskinpreparationusingaqueousPVP-I.OutcomesPrimaryoutcomewillbeincidenceofSSI,asdefinedbytheCentresforDiseaseControlandPrevention(CDC)(pus,positivewoundswab,andtwoSSIsymptoms).Secondaryoutcomeswillincludeincidenceandprevalenceofmicrobialspeciesonswabstakenintra-operatively,patient-centredcomplicationsofskinpreparationincludingirritation,andcostutilitybasedontheNNT.

13.Whatistheoptimaltimetostartadanglingregimeafterfreeflapreconstructionofthelowerlimb

LilliCooper,JamesMcGhee,SamOrkar,LorraineHarryandTaniaCubisonQueenVictoriaHospital,EastGrinsteadItiscommonpracticetorehabilitatefreeflapsusingadanglingregime.However,thereisnoevidencetodeterminetheoptimumtimetobegindangling.Currentevidencesuggestsdanglingissafefromasearlyasday3basedonphysiologyandsomeclinicalstudies.Theaimofthisstudywouldbetodeterminetheoptimalsafetimetostartdanglingtheflapaftersurgery.P-Adultsundergoingfreeflapreconstructiontothelowerlimbforanyaetiology.I/C-Oneinterventiongrouptostartdanglingonday3,thecontrolgroupwillstartdanglingonday5asthisiscommonpracticeintheUK.O-Theprimaryoutcomeswillbeflapsurvivalandhospitallengthofstay.Secondaryoutcomestobemeasuredwillbe:complications;returnstotheatre;patientsatisfaction.Subgroupanalysiscouldbeperformedwithregardstoflaptypeandpatientcomorbiditiesaffectingwoundhealing.

14.VivostatandReCellforAdultBurnSplit-thicknessSkinGrafting:ARandomisedControlledClinicalTrial

JustinWormald,DeclanCollins,ZaidAlqalaf,IsabelJones,JoanneAtkinsLondonAdultburnsarecommonandreportedincidencenumbersincreaseyearlywithover19,000adultburnsreportedin2014intheUK.Surgicaltreatmentisoftenwithburndebridementandsplit-skingrafting(SSG)intheacutesetting.AcommoncauseoffailureofSSGisgraftlosssecondarytohaematoma,mechanicalshearingandinfection.VivostatTMisatopicalhaemostaticagentconsistingofautologouspatient-derivedfibrinthathasbeensuccessfullyutilizedinpulmonarylobectomy(levelIevidence),pilonidaldiseaseandinachievinghaemostasisatSSGdonorsites.VivostatTMiscurrentlyinusetoaidadherenceofSSGstorecipientsitesandreducehaematomaformationinacuteburnssurgery,howevertheevidenceforitsuseinthissettingisminimal.Ourcentrecurrentlyisusingthistechnologyonrecipientanddonorsitesforburnssurgeryandpreliminaryresultsarepromising.WethereforeproposetoexpandthistoarandomisedcontrolledtrialofSSGandVivostatTMwithandwithoutReCellTM,anautologousnon-culturedcelltherapy,versusSSGalonetoestablishitsefficacyintermsofgrafttake,timetohealingandcosmeticoutcome.Participants:Adultpatients>18yearsoldwithfullthicknessburnsrequiringdebridementandgraftingIntervention• Intervention1:SSGandVivostatTM• Intervention2:SSGandVivostatTMplusReCellTMControl• ConventionalSSGOutcomes(measures):• Clinical:grafttake(clinicalassessment),rateofhaematoma(clinicalassessment),daystocompletehealing,post-oppain(VAS)• Patientrelatedoutcomemeasure:POSASscale• Costanalysiscomparedtoconventionaltherapy

15.FifthMetacarpalBaseInjuryOutcomesTrial

CobbW,DingleL,ZarbAdamiR,RodriguesJOxfordFracturedislocationsofthehamate-fifthmetacarpaljointarecommoninjuries,oftenresultingfromaxialforcealongthefifthfingermetacarpaltypicallyresultinginfractureofthefifthmetacarpalbasewithdorsalsubluxationordislocation.ManagementoptionsvarygreatlybetweenOpenReductionandInternalFixation(ORIF),Kirschnerwire(K-Wire)fixationandConservativemanagement.Thereisnoestablishedconsensusonoptimalmanagement.WeperformedaPRISMA-Pcompliantsystematicreviewoftheseinjuries[presentlyunpublished],demonstratingonly4comparativestudies(levelIVevidence)ofmanagementoftheseinjuries,allwithmixedconclusions,methodologicalflaws,andheterogeneitybetweenstudies.Assuchthereremainssignificantclinicalequipoiseastobestmanagementoftheseinjuries,andarobustrandomisedcontrolledtrialisneededtoresolvethisuncertainty.Hypothesis:Weanticipatethatoperativefixationoftheseinjuriesreduceslongtermpainandpreservesfunction.Methodology:Weproposeapragmaticmulti-centrerandomizedcontrolledtrial.Thisislikelytorequireapilotstudyofincidence,equipoiseandfeasibility(withitsowndeliverables),withprogressiontofulltrialbasedondefinedstop-gocriteria.Population:Fulltimeworkingadultswithclosedfracture/dislocationinjuriesofthefifthmetacarpal-hamatejointIntervention:ClosedreductionandKWiring,thenimmobilizedinplasterofparisControl:ClosedreductionandplasterofparisOutcome:TheprimaryoutcomewillbeLongtermhandfunction.Secondaryouctomeswillincludeincidenceofchronicpain,stiffness,timetoreturntowork,andpatientsatisfaction.