INTERNATIONAL JOURNAL OF NURSING STUDIES

INTERNATIONAL JOURNAL OF NURSING STUDIES

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Dr NICK SEVDALIS

King’s College London, London, UK Professor MARITTA VÄLIMÄKI University of Turku, Turku, Finland

EDITORIAL BOARD

Predictive factors for the formation of tape blisters: An observational, prognostic prospective study

Lara Pierboni

^a,

*, Elisabetta Fabbri

^b

, Antonietta Santullo

^c

, Elisa Ambrosi

^d

, Domenica Gazineo

^e

, Paolo Chiari

^d

aNursingandTechnicalDirection,AUSLRomagna,Rimini’sArea,FC,Italy

bDepartmentofResearchandInnovation,AUSLRomagna,Rimini’sArea,FC,Italy

cQualityandorganizationresearchandinnovation,AUSLRomagna,Rimini’sArea,FC,Italy

dDepartmentofMedicalandSurgicalSciences,UniversityofBologna,Italy

eEvidenceBasedNursingCentre,S.Orsola-Malpighi,TeachingHospital,Bologna,Italy

ARTICLE INFO

Articlehistory:

Received26February2018

Receivedinrevisedform13September2018 Accepted28September2018

Keywords:

Arthroplasty Orthopaedicsurgery Chestsurgery Predictivefactors Tapeblisters Tapedressing

ABSTRACT

Background:Tapeblistersarecommoncomplicationsintheperi-lesionalareaofthesurgicalincision, formingbelowthelayerofdressingadhesiveappliedandcausingnumerouscomplicationsforpatients.

Objectives:Thepurposeofthisstudywastoinvestigatetheincidenceofthephenomenon,andto identifyandquantifythemainprognosticfactorsassociated.

Design:Multicentric,prognosticprospectivecohortstudy.

Setting:ShoulderOrthopaedicsurgery,Generalsurgery,AdvancedOncologytherapies,Gastro-entero mininvasivesurgeryandEndocrinesurgery.

Participants:Onethousandandtwopatientswhounderwentchest,abdominal,upperlimbandjoint laparotomicsurgeryconsecutivelyadmittedtothesurgicalunitsinvolved,wereincluded.

Methods:Dataregardingindividualandpatientcarevariables,suchasintrinsic(e.g.ageandgender) andextrinsic(e.g.surgerytypeandtime)datawerecollected.Amultivariatelogisticregressionmodel wasusedtoidentifythevariableswhichindependentlyinfluencedtheonsetofthetapeblister.

Results:Inthemultivariateanalysis,patientswhounderwentchest(OddsRatio=8.99,95%CI5.33–

15.13),andupperlimbandjointsurgery(OddsRatio=2.09,95%CI1.22–3.58)weremorelikelytodevelop tapeblistersinthepostoperativeperiod,Atthesametime,havingdrainage(OddsRatio=1.98,95%CI 1.11–3.53),beingfemale(OddsRatio=1.56,95%CI1.01–2.44)andhavingahighBodyMassIndex(BMI) score(OddsRatio:1.06,95%CI1.02–1.11)werealsopredictorsoftapeblisterformation.

Conclusions:AhigherBMIscore,chest,upperlimbandjointsurgery,femalegenderandthepresenceof drainagewerepredictivefactorsofthetapeblistereventwhile,incontrastwiththeliterature,thetypeof dressingusedinthisstudywasnotsignificantlyassociatedwiththeevent.

©2018PublishedbyElsevierLtd.

Whatisalreadyknownaboutthetopic?

Tapeblistersareacommonclinicalproblemafterhipandknee surgery.

Previous studies reported the dressing type as the most importantprognosticfactoroftapeblisterdevelopment.

Theincidenceoftapeblisterscanbesignificantlyreducedusing perforatedstretchableclothtape.

Whatthispaperadds

 Tapeblisterformationalsooccursinothertypesofsurgery,in particularinchest,andupperlimbandjointsurgery.

 Surgerysite, femalegenderand thepresence of drainageare predictive factors of tape blister development in surgical patients.

1.Introduction

Tape blisters are subepidermal vesicles forming generally below the portion of surgical tape and represent a common complicationforpatientswhoundergosurgerywithanincidence

* Correspondingauthorat:ViaRecanati,no25,61036CollialMetauro,PU,Italy.

E-mailaddresses:larapierboni@libero.it,lara.pierboni@auslromagna.it (L.Pierboni),elisabetta.fabbri2@auslromagna.it(E.Fabbri),asantullo@auslrn.net (A.Santullo),elisa.ambrosi2@unibo.it(E.Ambrosi),domenica.gazineo@aosp.bo.it (D.Gazineo),paolo.chiari@unibo.it(P.Chiari).

https://doi.org/10.1016/j.ijnurstu.2018.09.018 0020-7489/©2018PublishedbyElsevierLtd.

InternationalJournalofNursingStudies91(2019)xxx–xxx

ContentslistsavailableatScienceDirect

International Journal of Nursing Studies

j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / i j n s

varying from 6 to 38% (Wright, 1994; Jester et al., 2000;

Lawrentschuk et al., 2002; Cosker et al., 2005; Koval et al., 2007). Theirappearance determines itch, tension, burning and pain,and increasesthe susceptibilityof the surgical wound to infectionsand can causea delayin there-epithelisationofthe wound(Guptaet al., 2002). Furthermore,thepresence of tape blistersmakestheremovalofthetapedressingpainful,negatively affectingthepsychologicalwell-beingandthephysicalrecoveryof the patient (Holliworth and Collier, 2000; Kammerlander and Eberlein,2002).

Todate,thestudiesavailableontheinternationalscalehave beencarried out exclusively within clinical orthopaedic con- textsand,inparticular,onpatientswhounderwentkneeorhip surgeryandarthroplasty (Blaylock et al.,1995; Lawrentschuk etal.,2002;Kovaletal.,2003;Polatschetal.,2004).Amongthe prognostic factors evaluated in the literature, the type of dressing proves to have been the most predictive factor regardingtheappearanceoftapeblistersinthepostoperative phase. Many authors, by means of studies comparing the differentdressings (Wright,1994; Milneet al.,1999; Lawren- tschuk et al., 2002; Cosker et al., 2005; Nielsen et al.,2005;

Abuzakuket al., 2006; Ravenscroft et al., 2006; Koval et al., 2007;DaviesandRippon,2008;Clarkeetal.,2009;Tustanow- ski,2009;Collins,2010;Ouseyetal.,2013;Peletet al.,2012), haveconcludedthattheuseofalessclose-fitting,moreelastic and transparent silicone, hydrocolloid dressing is able to maintainhumiditybalance anddeterminesa lowerincidence oftapeblisters.Italsoreducesskinmacerationandtheriskof infectionsascomparedtonon-transparent,occlusivetape.

Other studies have hypothesised a few predisposingfactors (suchasage,gender,race,nutritionalstatus,allergies,comorbid- ities, smoking, surgery type and time, seasonal temperature, placement of medication, type of disinfectant and type of compression),butwithoutgivingevidencewhichquantifiestheir realinvolvement(Jesteretal.,2000;Fluhretal.,2002;Kovaletal., 2003;(Polatschetal.,2004;Diedrichsonetal.,2005;White,2005;

Clarkeetal.,2009;Tustanowski,2009).Suchfactorsmightcause inflammatoryreactions,oedemaandsorenessduringthepostop- erativephase,determininghostileeffectsontheprotection/barrier functionoftheskin,whichbecomesthinnerand,therefore,more susceptible totheapplication of some dressings(Dykes,2007;

Cutting,2008; Waringetal., 2011).However,ithasneverbeen possible to demonstrate a direct association with tape blister formation.Therefore,withconflictingresultsintheliterature,itis preferabletoadditionallyanalysesuchacomplication,aimingto identify the intrinsic (e.g. age, gender, comorbidities) and the extrinsic(e.g.surgerytypeandtime,typeofdisinfectant)factors whichdetermineitandquantifytheirprognosticvalue.

2.Aim

Thepurposeofthestudywastoevaluatetheincidenceoftape blisterformationaftersurgeryandtoidentifythemainprognostic factors.

3.Materialsandmethods

3.1.Design

Aprognosticmulticentriccohortstudywascarriedoutinthree hospitalsinnorthernItaly.

3.2.Setting

The study involvedthedepartments of orthopaedic surgery, generalsurgeryandspecialisedsurgery.

3.3.Objectives

Theprimaryobjectiveofthestudywastoidentifytheincidence oftapeblisterformationduringthepostoperativephaseinpatients undergoingsurgery.

Thesecondaryobjectivewastodeterminethemainprognostic factorsandstudytheirinteractions.

3.4.Datasource

The patients were recruited according to the following inclusion criteria:age  18 years old undergoing elective and urgentlaparotomicsurgery.Patientswereexcludedfromthestudy in case of death during the postoperative period, transfer to another hospital ward not involved in the study or when the surgical tape was no longer necessary on the basis of clinical judgementandwithdrawalofconsent.

3.5.Variablesandmeasurements

3.5.1.Intrinsicvariables

Athospitaladmission,age,gender,presenceofallergies,Body Mass Index (BMI) and comorbidities (cardiovascular disease, neurodegenerative disease, diabetes mellitus, kidney failure, cancer,cirrhosisoftheliver,autoimmunedisease)wereassessed;

Furthermore, body temperature and oedema of tissues peripheraltothesurgicalsite24haftersurgerywereassessed.

3.5.2.Extrinsicvariables

Athospitaladmission,cortisonetherapyathome(considered positiveforanydrugbelongingtotheclassofcorticosteroidsand foranyform);hairremovalandhairremovaltools(clippers,cream, razors,wax)wereassessed.

Immediatelyaftersurgeryuponleavingtheoperatingtheatre, thesurgicalsite(chest,abdomen,upperlimbsandjoints);surgical classification (clean, contaminated-clean, contaminated, dirty);

typeofanaesthesia(generalsedation,conscioussedation,spinal/

epidural, local); American Society of Anaesthesiologists (ASA) score;antisepticusedintheoperatingroom;durationofsurgery;

type of suture (absorbable sutures, non-absorbable sutures, stainless steel sutures); compressive dressing; type of dressing (sterilised gauze + Hypafix [BSN medical], medicated plaster Farmapore[MedicalSolutions],AquacelAGSurgical[ConvaTec]) andpresenceofdrainagewereassessed.

Inordertoassesstheprimaryendpoint,theperi-incisionalarea wasobservedforeachpatient,soastoverifythepresence/absence oftapeblisterformation,andthenumberandthedimensionsof thewounds,foraminimumofthreeobservations:

-More than 24h after surgery, only if the dressing was particularlysoakedorforothercomplications.

-Afterthefirst24h,atthemomentofchangeofdressing,fora maximumofoneevaluationaday.

-During postoperative scheduled check-up performed in an outpatientregimenapproximatelysevendaysafterdischarge.

3.6.Dataanalyses

Forre-elaborationofthedata,aninitialdescriptivestatistical analysis was carried out in order to obtain the principal information regarding the sample, followed by a univariate analysis to investigate the potential presence of significant associationsorcorrelationsbetweenthesinglevariablesandthe outcome(onsetoftapeblisters).Theanalysiswascarriedoutusing theChi-squaredtestbetweencategoricalvariables,theStudent’st-

testforindependentgroupsforquantitativevariablesinanormal distributionandtheMann-Whitney’stestforthosenotnormally distributed.

Thevariablessignificantlyassociatedwithoutcomeatunivari- ateanalysis,wereenteredinafinallogisticregressionmodelusing forwardselection,tofindtheindependentpredictorsofthetape blisterdevelopment.Ifmorethanonevariablewithsimilarclinical significanceshowedstatisticalassociationwithoutcome,onlyone wasenteredinthefullmodel,toavoidco-linearity.Kaplan-Meyer survivalanalysiswasconductedtoassessthesurvivalfunctionof thetimetakenfortapeblistersonsetfordifferenttypesofsurgical site,andlog-rankwasselectedtotestintergroupdifference.The finalmodelwastestedinthewholestudypopulation.Dataanalysis was performed using STATA program version 9.2. The level of significancewassetat0.05.

3.7.Ethicalapproval

Ethicalapprovalforconductingclinicalresearchwasobtained fromthecompetentEthicsCommitteeofMeldola,Forlì,Italy.All theparticipantswereinformedregardingthepurposeofthestudy, andwrittenconsentwas obtainedfrompatientsand fromlegal representativefor those unable toprovideconsent for medical reasons.Theirparticipationwasvoluntary,anddataconfidentiality wasguaranteed.

4.Results

4.1.Sampledescription

Theaverageageofthepatientswas62.81years(16.55S.D.), 48.5% of the participants were female, 21.46% of participants displayed known allergies to medications while 68.96% were affectedbycomorbidities,theaverageBMImeasuredwas 26.35 (5.05 S.D.) and 89.72% of patients had undergone scheduled surgery.

Inthe1002recruitedpatients,therewere106verifiedcasesof tapeblisterformation,withanincidenceof10.58%.

In72.6%ofthepatients,tapeblistersoccurred2or3daysafter surgery,observedupto8days.

4.2.Univariatestatistics

Thedatacollectedwereexaminedbyrelatingtheoutcometo eachindividualvariabletakenunderexamination.Theresultsare reportedinTable1.

In the univariate analysis the factors associated with the outcomewere: gender,BMI, executionofhair removaland the methodbywhichitwasperformed,thesurgicalsite,thesurgical classificationandthepositionofthedrainage,theformationof oedemaintheperi-incisionalsite,asshowninTable1.

4.3.Multivariateanalysis

All the variables which turned out to be significant in the univariate analysis were included in the model for logistic regression which additionally selected only specific variables.

Theprognosticfactorsselectedbythemodelforlogisticregression, withtherelatedadjustedOR,areconsideredinTable2.

Forthechestsite,theriskoftapeblisterincreasedalmost9-fold (OR 8.99;95% confidenceinterval (CI)5.33–15.13),also for the upperlimbandjointsitetheriskincreased2-fold(OR2.09;95%CI 1.22–3.58).Drainageincreasedtheriskalmost2fold(OR:1.98;CI 95%1.11–3.53).Femalegenderhadanincreasedriskof56%(OR:

1.56;95%CI1.01–1.11).EachpointoftheBMIincreasedtheriskby 6%(OR:1.06;95%CI1.02–1.11).

4.4.Survivalanalysis

Fig. 1 shows how the surgical site strongly affected the outcomeandtheonsettimeoftheblisters:group2(chestsite) presented a significant worse trend compared to group 0 (Abdomensite)and1(UpperLimbandJointssite),withanearly separation of the curvesafter oneday(p<0.001).Three days aftersurgery,thecumulativeincidenceoftapeblistersingroup 2 wasalmost 35%,andthis reached>50% byeight daysafter surgicalprocedure.Ingroup1,thecumulativeincidencereached 35%sixdaysaftersurgery.Noticethatthefollow-uplastedno morethaneightdaysaftersurgery.

5.Discussion

Inthisstudy,theincidenceoftapeblisterformationwas10.58%, thedatareflectedtheliterature(Wright,1994;Jesteretal.,2000;

Lawrentschuketal.,2002;Coskeretal.,2005;Kovaletal.,2007).

Unlike previousstudy results(Wright,1994; Milneet al.,1999;

Lawrentschuketal.,2002;Coskeretal.,2005;Nielsenetal.,2005;

Abuzakuketal.,2006;Ravenscroftetal.,2006;Kovaletal.,2007;

Clarkeetal.,2009;Collins,2010;Ouseyetal.,2013;Peletetal., 2012), the different types of dressing were not a risk factor associatedwithtapeblisteronset.

Of the prognosticfactors identified, the surgical site repre- sentedanindependentfactor,inparticulartheupperlimbsand joints’doubledtheriskofonsetoftheoutcomewhereasthechest increasedtheriskalmostninefoldmorethantheabdomenwhich, inthisstudy,provedtobelessatriskoftapeblisterformation.For thisreason,theabdomensitewasconsideredasthebaselineof referencefortheothersurgicalsites.Sucharesultcanbejustified bythemusculardynamicsofthetissuesexposedtocontinuous stretching,inparticularonthetissuesat thechestlevel, where breathingdeterminedacontinuousextensionofthedermisand epidermis which favours the detachment of the two layers, determiningtheformationoftapeblisters.

The oedema variable, even though significant both in the literature(Jesteretal.,2000)andintheunivariateanalysis,wasnot usedforthecreationofthemodelforlogisticregressionsinceit seemedtobeexcessivelyassociated withothervariableswhich werealreadyconsideredinthemodel,suchasdrainageandBMI.

Contrarytowhathasbeenstatedintheliterature,someofthe intrinsicfactorsinvestigatedinthisstudyseemedtobepredictive ifassociatedwiththeonsetoftapeblisterformation.Inparticular, gender,previouslyinvestigatedbyKovaletal.in2003andin2007, who had hypothesised the connection with the tape blister formation,washereindemonstratedtobesignificativelyassociat- edwiththeoutcome(p=0.047).

Thefemalegenderpresentedariskwhichwas56%higherthan themalegender(OR1.56),regardingthepossibledevelopmentof tape blister formation.In 2000, Jesteret al. indicatedBMI asa nutritionalstatusandmadeit apotentiallypredisposingfactor;

however,hedidnotanalyseit.

Inthisstudy,itwassuggestedthattheadditionofeachpointof BMIdeterminedanincreaseintheriskofonsetoftheoutcomeof 6%.

Thepresence ofdrainagehadnever previouslybeeninvesti- gated as a prognostic factor in the literature; in this study, it appearedtobelinkedtoatwo-foldincreaseintheriskofonsetof tapeblisters(OR1.98)ascomparedtoitsabsence.Drainageand BMIdetermineanincreaseinthesurfacetensionoftissuesand, togetherwiththesurgicalsite,supportthehypothesisofitbeinga dynamiccauseoftapeblisterformation.Finally,survivalanalysis showed that blisters onset trends significantly varied across differentsurgicalsites,butfurtherresearchisneededtoconfirm thisdifferenceinotherclinicalsettings.

L.Pierbonietal./InternationalJournalofNursingStudies91(2019)xxx–xxx 3

Table1

Characteristicsofthesamplebasedontheoutcome(onsetoftapeblisterformation).UnivariateAnalysisofallthedifferentvariableschosen.

Variables Noblistersobserved

n.896(%)

Blistersobserved n.106(%)

p

Malegender 473(52.8) 43(40.6) 0.017

Averageage(DS) 62.5(16.8) 65(14.3) ns

AverageBMI(DS) 26.13(4.9) 28.11(6) <0.001

Allergies 192(21.4) 23(21.7) ns

Comorbidities 613(68.4) 78(73.6) ns

Cortisonetherapy 26(83.9) 5(16.6) ns

Hairremoval 608(67.9) 57(53.8) 0.001

Hairremovaltools 0.006

Clippers 250(41.1) 20(35.1)

Razors 133(21.9) 9(15.8)

Cream 216(35.5) 27(47.4)

Wax 9(1.5) 1(1.7)

Surgicalsite <0.001

Chest 72(8.0) 42(39.6)

Abdomen 594(66.3) 38(35.8)

Upperlimbsandjoints 230(25.7) 26(24.5)

Surgicalclassification 0.001

Clean 379(42.3) 50(47.2)

Contaminated-clean 223(24.9) 40(37.7)

Contaminated 194(21.6) 13(12.3)

Dirty 100(11.2) 3(2.8)

Typeofanaesthesia ns

Generalanaesthesia 757(84.5) 85(80.2)

Conscioussedation 3(0.3) 0(0)

Epiduralorspinal 17(1.9) 2(1.9)

Nerveblockanaesthesia 7(0.8) 0(0)

Combinedgeneralandepiduralorspinalanaesthesia 3(0.3) 2(1.9) ns

Combinedgeneralandnerveblockanaesthesia 109(12.2) 17(16.0)

ASAscore ns

I 116(13) 8(7.5)

II 417(46.8) 59(55.7)

III 354(39.7) 39(36.8)

IV 4(0.4) 0(0)

Averagesurgicaltime(inminutes)(DS) 153(121) 129(112) ns

Antisepticsolutions ns

Poviderm10% 888(98.3) 105(99.1)

Chlorhexidine2% 15(1.7) 1(0.9)

Typesofsuture ns

Absorbablesutures 136(15.2) 11(10.4)

Non-absorbablesutures 288(32.2) 26(24.5)

Stainlesssteelsutures 457(51.1) 64(60.4)

Combinedabsorbableandnon-absorbablesutures 3(0.3) 1(0.9)

Combinedabsorbableandstainlesssteelsutures 3(0.3) 1(0.9)

Combinednon-absorbableandstainlesssteelsutures 8(0.9) 3(2.8)

Non-compressivedressing 188(21) 24(23) ns

Typeofdressing ns

AquacelAgSurgical(ConvaTec) 9(1.0) 1(0.9)

Medicatedplaster‘Farmapore’(MedicalSolutions) 651(73.0) 71(67.0)

Sterilegauzeandadhesiveplaster‘Hypafix’(BSNmedical) 219(24.5) 30(28.3)

Elastocompressivedressing 13(1.1) 4(3.8)

Drainage 605(67.67) 88(83.8) 0.001

Bodytemperatureat24hourspost-surgery 0.06

Tc<=37 607(67.7) 63(59.4)

37.1<=Tc<=38 273(30.5) 38(35.8)

Tc>=38,1 16(1.8) 5(4.7)

Tissueoedema 16(1.8) 10(9.43) <0.001

ns=notstatisticallysignificant.

Missing;ASAscore=5;TypeofSuture=1;TypeofDressing=4.

Table2

Multivariateanalysis.Modelforlogisticregression(n.1002).

Variables OddsRatio p 95%ConfidenceInterval

Chestsite(abdominal) 8.99 0.000 5.33–15.13

UpperlimbandJointsite(abdominal) 2.09 0.008 1.22–3.58

IncreaseinBMI 1.06 0.002 1.02–1.11

Gender(female) 1.56 0.047 1.01–2.44

Drainage(yes) 1.98 0.021 1.11–3.53

Whererelevant,thereferencecategoryisgiveninparentheses.

5.1.Limitationsofthestudy

Oneofthemostimportantlimitationsinthisstudyisrepresented bythefactthatonlyafewofthepossibleareasofsurgicalincision wereinvestigated.Thischoiceliesinthefactthat,ifextendedtoall thesurgicalincisionsites,thestudywouldhavebeentoolongand dispersive.Forthisreason,itwasdecidedtolimittheobservationto theupperlimbsandthejoints,theabdomenandthechest.Evenifit wasamulticentricstudy,thetypesofdressingusedwereveryfew sincetheywerelimitedtohospitalsinthesamehealthcarearea.The choiceof thevariablestakenintoaccountwasrestricted bythe literatureanalysisandtheexperienceofthehealthcareproviders;it ispossiblethatothervariableswhichmighthavebeensignificantfor thestudywerenotconsidered.

6.Conclusions

Theincidence of tapeblister formation in thepostoperative phasewas10.58%whereasthemainprognosticfactorswerethe surgicalsitesinthechest,upperlimbsandupperlimbjoints,the presenceofdrainageplacedduringsurgery,femalegenderandan increaseinBMI.Incontrastwiththeliterature,thetypeofdressing usedinthisstudywasnotsignificantlyassociatedwiththeevent.

Additionalstudiescouldverifythisaspect.

This study did not receive any specific grant from funding agenciesinthepublic,commercialornot-for-profitsectors.

Conflictofinterest

Noneoftheauthorshasanyconflictsofinteresttodeclare.

Funding

Nonedeclared.

Acknowledgments

Wethankthenursingstaffofthesurgicalwardsofthehospitals in Cattolica, Riccione, Rimini and Forli for helping with

commitment and perseverance to collect data relevant to the studyandallowingtheelaborationoftheseresults.

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L.Pierbonietal./InternationalJournalofNursingStudies91(2019)xxx–xxx 5

Accepted Manuscript

Title: Skin complications associated with vascular access devices: A secondary analysis of 13 studies involving 10,859 devices

Authors: Amanda J. Ullman, Gabor Mihala, Kate O’Leary, Nicole Marsh, Christine Woods, Simon Bugden, Mark Scott, Claire M. Rickard

PII: S0020-7489(18)30252-9

DOI: https://doi.org/10.1016/j.ijnurstu.2018.10.006

Reference: NS 3237

To appear in:

Received date: 2 May 2018 Revised date: 3 October 2018 Accepted date: 3 October 2018

Please cite this article as: Ullman AJ, Mihala G, O’Leary K, Marsh N, Woods C, Bugden S, Scott M, Rickard CM, Skin complications associated with vascular access devices:

A secondary analysis of 13 studies involving 10,859 devices, International Journal of Nursing Studies (2018), https://doi.org/10.1016/j.ijnurstu.2018.10.006

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Skin complications associated with vascular access devices: A secondary analysis of 13 studies involving 10,859 devices

Dr Amanda J Ullman

^1,2,3,4,

Gabor Mihala

^1,5

, Kate O’Leary

¹

, Nicole Marsh

^1,2,3

, Christine Woods

^1,3

, Dr Simon Bugden

⁶

, Dr Mark Scott

⁶

, Professor Claire M Rickard

^1,2,3,4

Affiliations:

1

Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Nathan, QLD 4111

2

School of Nursing and Midwifery, Griffith University, Nathan, QLD 4111

3

Royal Brisbane and Women’s Hospital, Herston QLD 4029

4

Lady Cilento Children’s Hospital, South Brisbane QLD 4101

5

Centre for Applied Health Economics, Menzies Health Institute Queensland, Nathan, QLD 4111

6

Caboolture Hospital, Metro North Hospital and Health Service, North Brisbane QLD 4510

Address correspondence to: Dr Amanda Ullman, School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, N48 Kessels Road, Nathan, Queensland 4111, Australia. Tel: +61 (0)7 3735 6462; Email: a.ullman@griffith.edu.au

Short title: Skin complications with vascular access

ABSTRACT

Background: Vascular access devices are widely used in healthcare settings worldwide. The insertion of a vascular access device creates a wound, vulnerable to irritation, injury and infection. Vascular access-associated skin complications are frequently reported in the literature, however very little evidence is available regarding the incidence and risk factors of these conditions to inform practice and technology development.

Objectives: To estimate the incidence of vascular access-associated skin complications, and to identify patient, catheter and healthcare-related characteristics associated with skin complication development.

Design: Secondary data analysis from 13 multi-centre randomised controlled trials and observational studies evaluating technologies and performance of vascular access devices in clinical settings between 2008 and 2017.

Settings: Six hospitals (metropolitan and regional) in Queensland, Australia.

Participants: The 13 studies involved paediatric and adult participants, across oncology, emergency, intensive care, and general hospital settings. A total of 7,669 participants with 10,859 devices were

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included, involving peripheral venous (n=9,933), peripheral arterial (n=341), and central venous access (n=585) devices.

Analysis: Standardised study data were extracted into a single database. Clinical and demographic data were descriptively reported. Cox proportional hazards regression models (stratified by peripheral vs central) were used for time-to-event, per-device analyses to examine risk factors. Univariate associations were undertaken due to complexities with missing data in both outcomes and covariates, with p<0.01 to reduce the effect of multiple comparisons.

Results: Over 12% of devices were associated with skin complication, at 46.2 per 1,000 catheter days for peripheral venous and arterial devices (95% confidence interval, CI 42.1- 50.7), and 22.5 per 1,000 catheter days for central devices (95% CI 16.5-306). The most common skin complications were bruising (peripheral n=134, 3.7%; central n= 33, 6.8%), and swelling due to infiltration for peripheral devices (n=296; 2.9%), and dermatitis for central devices (n=13; 2.2%). The significant risk factors for these complications were predominantly related to device (e.g., skin tears associated with peripheral arterial catheters [hazard ratio, HR 16.0], radial insertion [HR 18.0] basilic insertion [HR 26.0])) and patient characteristics (e.g., poor skin integrity associated with increased risk of peripheral device bruising [HR 4.12], infiltration [HR 1.98], and skin tear [HR 48.4]), rather than management approaches.

Conclusions: Significant skin complications can develop during the life of peripheral and central vascular access devices, and these are associated with several modifiable and non-modifiable risk factors. Further research is needed to evaluate effectiveness technologies to prevent and treat skin complications associated with vascular access devices.

Abbreviations: BMI = body mass index; CVAD = central venous access device; IQR=

Interquartile range; HR = hazard ratio; MARSI = medical adhesive related skin injury; RCT = randomised controlled trial; VA= vascular access; IR = incidence rate; CI = confidence interval;

KEYWORDS: Vascular access, Wound care, Skin, Evidence-based nursing

CONTRIBUTION OF THE PAPER What is already known on this topic?

The skin surrounding vascular access devices is exposed to irritation and trauma, associated with device management, resulting in complications such as bruising and dermatitis.

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The incidence of these complications, and the risks associated with their development, have not previously been clearly estimated.

What does this paper add?

Significant skin complications frequently develop around peripheral and central vascular access devices, with bruising, infiltration and dermatitis the most common.

Risk factors were mostly associated with device (e.g., peripheral device placement) and patient (e.g., increasing age, co-morbidities) characteristics, rather than management (e.g., dressings).

BACKGROUND

Worldwide, vascular access devices play a vital function within healthcare. Almost all patients admitted to hospital require some form of vascular access to facilitate the administration of short and long-term treatments (Ullman et al., 2015). However patients relying on vascular access can be complex, and are often at extremes of age, or have chronic health conditions such as cancer or renal failure (Broadhurst et al., 2017, Thayer, 2012).

Clinicians are focussed on the prevention of harm associated with vascular access devices. The prevention of local and systemic infections associated with these devices are of high priority, and strategies such as skin decontamination using solvents and detergents (e.g., chlorhexidine gluconate) are used to prevent extra-luminal colonisation by bacteria (e.g., Staphylococcus aureus)(Mimoz et al., 2015). Dressing and securement technologies, such as sutures, medical adhesives and manufactured devices, are applied to prevent vascular access dislodgement and skin contamination (Marsh et al., 2015, Ullman et al., 2015). While these strategies reduce systemic infections and promote device performance, they also expose the vascular access site to repeated potential irritation and trauma.

Skin complications associated with vascular access devices are distressing, disfiguring to the skin (i.e., scarring) and frequently result in device failure (Broadhurst et al., 2017). These complications involve a range of conditions including bruising, venous infiltration and extravasation, local site infections, pressure injuries, moisture-associated skin damage (e.g., maceration), contact dermatitis, and mechanical skin injuries, such as skin tears and blisters (Broadhurst et al., 2017, McNichol et al., 2013, Thayer, 2012). Signs and symptoms include itch, erythema, and pain, (McNichol et al., 2013, Thayer, 2012). While these conditions and symptoms are significant, and frequently reported in the literature (Kutzscher, 2012, LeBlanc and Baranoski, 2011, McNichol et al., 2013, Thayer, 2012, Ullman et al., 2015, Wall et al., 2014), robust, systematic evidence concerning vascular access-associated skin complication incidence and modifiable risk factors, are sparse.

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Single site, observational studies in mixed settings (Farris et al., 2015, Konya et al., 2010) have reported overall medical adhesive-related skin injury prevalence (across all types of exposure to medical adhesive) of 3-25%, with the highest risk in elderly patients (Farris et al., 2015), and those with vascular access devices (Konya et al., 2010). A recent Australian point prevalence study (Ullman et al., 2017) demonstrated 10% of paediatric central vascular access devices were associated with a skin complication, such as dermatitis and/or bruising. A Cochrane Systematic review (Ullman et al., 2016, Ullman et al., 2015) examining the effects of central vascular access device dressing and securement reported only 5 of the 22 trials (n=1,159) collected skin irritation and damage, and within these there was no clear evidence of differences in skin complications for a variety of dressing and securement devices.

Vascular access-associated skin complications are a significant and potentially avoidable burden on the healthcare system. However, greater evidence describing the associated risk factors is required in order to guide best practice policies, and focus expensive interventions appropriately. Risk factors associated with other types of vascular access complications have focussed on the examination of patient- (e.g., age, co-morbidities, nutrition status, pre-existing skin conditions), device- (e.g., device type, insertion location) and healthcare- (e.g., dressing and securement products, antisepsis, inserter clinicians) related characteristics (Chopra, 2012). A similar approach is evident in studies examining other forms of skin complications, including incontinence-associated dermatitis (Kottner et al., 2014) and pressure injuries (Webster et al., 2015). Thereby, this study aimed to estimate the incidence of vascular access-associated skin complications, and to identify patient-, device- and healthcare-related characteristics that are associated with an increased or decreased risk for vascular access-associated skin complications. The identification of risk factors can then be used to support the development of innovative interventions for appropriate patient groups, to prevent and treat these complications and ensure the efficient use of health resources.

METHOD

Design: A secondary data analysis of 13 multi-centre randomised controlled trials and observational studies evaluating technologies and performance of vascular access devices undertaken in clinical settings between 2008 and 2017. Together these studies involved 10,859 devices inserted in 7,669 participants. This combined data set was analysed to examine the effect of pre-specified potential patient-, device- and healthcare-related risk factors on the development of vascular access associated skin complications and associated symptoms.

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Types of studies: Data were extracted from 12 randomised controlled trials (Bugden et al., 2016, Chan et al., 2017, Edwards et al., 2014, Kleidon et al., 2017, Marsh et al., 2018, Marsh et al., 2015, Reynolds et al., 2015, Rickard et al., 2016, Rickard et al., 2015, Rickard et al., 2012, Ullman et al., 2017, Webster et al., 2017) and one prospective cohort study (Marsh et al., 2018) completed by the Alliance for Vascular Access Teaching and Research group, and combined into a single database for analysis. The individual studies examined the efficacy of vascular access dressing and securement products (Bugden et al., 2016, Chan et al., 2017, Edwards et al., 2014, Kleidon et al., 2017, Marsh et al., 2018, Marsh et al., 2015, Reynolds et al., 2015, Rickard et al., 2016, Rickard et al., 2015, Ullman et al., 2017, Webster et al., 2017), evaluated the effectiveness of routine peripheral vascular access device replacement (Rickard et al., 2012), and observed vascular access-associated management and outcomes (Marsh et al., 2018). Each study included prospectively collected data, including standardised terms surrounding patient-, device- and healthcare- characteristics of study participants, and skin complications. Data were collected on peripheral arterial, peripheral venous and central venous access devices across six hospitals in Queensland, Australia between 2008 and 2017. All six hospitals involved in the trials were large metropolitan or regional hospitals, with one specialising in paediatrics, managing a combined total of 480,000 admissions per year.

Ethical approval for each trial was obtained from the appropriate health service and Griffith University human research ethics committee, including an approval to reanalyse data in future research. Additional approval was received to undertake this secondary analysis via Griffith University human research ethics committee (GU Ref No. 2017/538).

Types of participants: The original studies included paediatric and adult participants, across oncology, emergency, intensive care, and general hospital settings. No studies included outpatients. While inclusion and exclusion criteria varied between studies, all dressing and securement randomised controlled trials specifically excluded patients with pre-existing skin complications surrounding the vascular access site, and known allergies/sensitivities to any of the study products (i.e., polyurethane dressings, tissue adhesive, sutureless securement devices). All participants and/or legal guardians provided written, informed consent prior to participation in the original trials.

Data collection: Trained research nurses were employed on each project and were responsible for data collection, de-identification, and entry into standardised and secure databases. Study data was extensively cleaned during original data analysis. The Research Nurse for the current project, then checked and combined these data into a single database for secondary analysis.

Outcome definitions: In this secondary analysis, outcomes were pragmatically divided into vascular access-associated skin complications and individual abnormal skin signs or symptoms that were not

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otherwise diagnosed as a specific complication. Vascular access-associated skin complications were defined as the presence of bruising, infiltration (involving localised swelling), dermatitis (as evidenced by a raised red rash, with or without vesicles, which persisted for greater than 30 minutes (Broadhurst et al., 2017, McNichol et al., 2013)), mechanical injuries such as skin tears and blisters (McNichol et al., 2013, Thayer, 2012), and local infections (purulent discharge, or redness extending 1 cm beyond the site that prompted clinicians to order vascular access device removal, or commence antimicrobial therapy (Ullman et al., 2016)), surrounding the vascular access site. Vascular access-associated individual abnormal skin signs or symptoms included fluid leakage, erythema, pain, and itch from the vascular access site.

The individual types of vascular access-associated skin complications and symptoms were secondary outcomes of each included study. Study data were only included in the analyses if the definition of the complications and symptoms met the above-mentioned criteria.

Variables: Potential patient-related, catheter-related and healthcare-related risk factors were developed a priori, after a systematic review of the literature and consultation with interdisciplinary, international key opinion leaders, ensuring the variables were also consistently collected in the original trials. The characteristics included age, primary diagnosis, systemic skin integrity overall (good [healthy, well hydrated, elastic], fair [intact, mildly dehydrated, reduced elasticity], or poor [papery, dehydrated, small amount or no elasticity]), skin type (Fitzpatrick scale (Fitzpatrick, 1988)), underlying co-morbidities (e.g. renal impairment, diabetes, circulatory disorders), nutrition status (described by Body Mass Index [BMI]), dressing products, securement products, insertion site and dwell time. Data were not available on site decontamination procedures. The included variables were each collected using standardised definitions, as part of the original trials.

Data analysis: The 13 individual study databases were exported and combined into a single database for secondary analysis, with additional data cleaning undertaken. The demographic and clinical characteristics were descriptively reported, using categorical and continuous descriptors appropriate to their distribution. The primary outcomes were time-dependent (incidence rates, survival data/hazard rates reported with 95% confidence intervals); thus, Cox proportional hazards regression models were used for time-to-event analysis. Regression analyses were stratified by device class (peripheral or central); per-device analysis was performed as per-patient analysis is not appropriate if device-related covariates vary within patients. Univariate associations were undertaken, due to complexities with missing data in both outcomes and covariates making multivariate regressions unfeasible. The association between skin complication and dwell time were explored graphically through Kaplan Meier estimates. Missing data were not imputed. Statistical significance was declared at p<0.01 to reduce the

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effect of multiple comparisons. The analysis was undertaken using Stata (version 15; StataCorp, College Station, TX).

RESULTS

Participant, device and dressing characteristics

Table 1 describes the baseline characteristics of participants and devices included in the analyses.

Participants’ median age was 59 years (IQR 42, 71), with only a small representation (<2%) being less than 16 years of age. Comorbidities were common, (79% reporting one or more), and the majority of patients had pale white to white skin (75%). Data were collected on peripheral arterial (n=341; 3%), peripheral venous (n=9,933; 91%) and central venous access (n=585; 6%) devices. One quarter of devices (n=2,579; 25%) were associated with a complication prompting device removal, with a median dwell of 2.4 days for peripheral devices (IQR 1.5, 3.6) and 4.8 days for central devices (IQR 2.6, 10.1).

As displayed in Table 2, the majority of vascular access sites were dressed with either plain (n=2,699;

55%) or bordered (n=1,802; 37%) polyurethane dressings, with no additional security (n=2,488; 49%).

Frequency of vascular access-associated skin complications, and signs and symptoms

Overall, 12.3% of peripheral devices (n=482; IR 46.2 per 1,000 catheter days [95% CI 42.1-50.7]) and 11.7% of central devices (n=40; IR 22.5 per 1,000 catheter days [16.5-30.6]) were associated with a skin complication after insertion (see Table 3). The most common vascular access-associated skin complications were bruising in peripheral (both venous and arterial) and central devices (3.7%, 6.8%

respectively), infiltration in peripheral devices (n=296; 2.9%) and dermatitis in central devices (n=13;

2.2%). There were infrequent reports of mechanical injuries or infections, however both were more common in central devices than in peripheral devices. Signs and symptoms of skin complications were more evident, with peripheral device leakage (n=2,069; 25%), peripheral and central device erythema (5.3%, 3.2% respectively) and peripheral device pain (n=626; 6.3%) at the vascular access site common.

The Kaplan-Meier estimates of skin complications over dwell time are presented in Figure 1. For the bruising and infiltration associated with peripheral vascular access devices the rate of failures was approximately constant in the first 8 days of dwell time. For central devices, the rate of bruising was approximately constant in the first 10 days of dwell time, while most other abnormalities appeared only well into the dwell time: dermatitis after 6 days, blister after 7 days, and tearing after 4 days (all approximate).

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Risk factors for vascular access-associated skin complications and symptoms in peripheral devices

The patient-, device- and healthcare-related risk factors associated with the development of skin complications and symptoms in peripheral devices are displayed in Table 4. Bruising was significantly associated with multiple patient and device characteristics, including increasing age (HR 1.01), medical diagnosis (HR 2.97), poor skin integrity (HR 4.12), wounds at baseline (HR 3.71), peripheral device insertion in the cephalic (HR 4.11) and foot (HR 3.15) veins (in comparison to forearm). Mechanical skin tears were significantly associated with poor skin integrity (HR 48.4), two or more comorbidities (HR >100), arterial devices (in comparison to venous; HR 16.0), and radial (HR 18.0) and basilic (HR 26.0) vessels (in comparison to forearm).

The only vascular access-associated skin complication or symptom associated with a dressing and securement product, was a significant increase in itch for tissue adhesive as a securement product (HR 6.92), in comparison to none.

Risk factors for vascular access-associated skin complications and symptoms in central devices The patient-, device- and healthcare-related risk factors associated with the development of skin complications in central vascular access devices are displayed in Table 5. Increasing age (HR 1.02) and wounds at baseline (HR 3.67) were associated with an increased risk of bruising. Co-morbidities were associated with a HR of >100, in development of dermatitis, while a medical diagnosis (in comparison to surgical diagnosis) was associated with a HR of >100, in development of a MARSI blister. The use of tissue adhesive was associated with a HR of >100, in the development of a MARSI skin tear. There were no significant risk factors identified with the development of skin signs and symptoms in central vascular access devices.

DISCUSSION

Using a large, high quality dataset, this secondary analysis has demonstrated that patients reliant upon vascular access for treatment, develop skin complications and, signs and symptoms surrounding their vascular access site during their placement. This represents the first systematic description of a significant healthcare-related injury, which is causing preventable harm to patient’s worldwide. Overall, skin complications developed in 12.3% of peripheral devices and 11.7% of central devices, with further signs and symptoms of skin complications also occurring. Skin complications surrounding the vascular access site included bruising, infiltration, dermatitis and mechanical injuries, which were not evident

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