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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.