Tissue adhesives for closure of surgical incisions

138 Pages·2015·1.27 MB·English

Tissue adhesives for closure of surgical incisions (Review)
Dumville JC, Coulthard P, WorthingtonHV, Riley P, Patel N, Darcey J, Esposito M, van der
Elst M, van Waes OJF
ThisisareprintofaCochranereview,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochraneLibrary
2014,Issue11
http://www.thecochranelibrary.com
Tissueadhesivesforclosureofsurgicalincisions(Review)
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SUMMARYOFFINDINGSFORTHEMAINCOMPARISON . . . . . . . . . . . . . . . . . . . 3
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ADDITIONALSUMMARYOFFINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . 20
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Analysis1.1.Comparison1Adhesiveversussuture,Outcome1Dehiscence:allstudies. . . . . . . . . . . 97
Analysis1.2.Comparison1Adhesiveversussuture,Outcome2Dehiscence:sensitivityanalysis. . . . . . . . . 99
Analysis1.3.Comparison1Adhesiveversussuture,Outcome3Infection:allstudies. . . . . . . . . . . . 100
Analysis1.4.Comparison1Adhesiveversussuture,Outcome4Infection:sensitivityanalysis. . . . . . . . . 101
Analysis1.5.Comparison1Adhesiveversussuture,Outcome5Cosmeticappearanceratedbypatient. . . . . . 102
Analysis1.6.Comparison1Adhesiveversussuture,Outcome6Cosmeticappearanceratedbysurgeon. . . . . . 102
Analysis1.7.Comparison1Adhesiveversussuture,Outcome7Patient/parentsatisfaction(%satisfied). . . . . . 103
Analysis1.8.Comparison1Adhesiveversussuture,Outcome8Patient/parentsatisfaction(VASScale0to100). . . 103
Analysis1.9.Comparison1Adhesiveversussuture,Outcome9Surgeonsatisfaction(%satisfied). . . . . . . . 104
Analysis1.10.Comparison1Adhesiveversussuture,Outcome10Timetakenforwoundclosure. . . . . . . . 105
Analysis2.1.Comparison2Adhesiveversusadhesivetape,Outcome1Dehiscence. . . . . . . . . . . . . 106
Analysis2.2.Comparison2Adhesiveversusadhesivetape,Outcome2Infection. . . . . . . . . . . . . . 106
Analysis2.3.Comparison2Adhesiveversusadhesivetape,Outcome3Cosmeticappearanceratedbypatient(VAS). 107
Analysis2.4. Comparison 2Adhesiveversusadhesivetape, Outcome4Cosmeticappearance ratedby patient(%
satisfied). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Analysis2.5.Comparison2Adhesiveversusadhesivetape,Outcome5Cosmeticappearanceratedbysurgeon(VAS). 108
Analysis2.6.Comparison2Adhesiveversusadhesivetape,Outcome6Patientsatisfaction. . . . . . . . . . 109
Analysis2.7.Comparison2Adhesiveversusadhesivetape,Outcome7Surgeonsatisfaction. . . . . . . . . . 109
Analysis2.8.Comparison2Adhesiveversusadhesivetape,Outcome8Timetakenforwoundclosure. . . . . . 110
Analysis3.1.Comparison3Adhesiveversusstaples,Outcome1Dehiscence. . . . . . . . . . . . . . . 110
Analysis3.2.Comparison3Adhesiveversusstaples,Outcome2Infection. . . . . . . . . . . . . . . . 111
Analysis3.3.Comparison3Adhesiveversusstaples,Outcome3Cosmeticappearanceratedbypatient(scarscale). . 111
Analysis3.4.Comparison3Adhesiveversusstaples,Outcome4Cosmeticappearancebyplasticsurgeons(VAS). . . 112
Analysis3.5.Comparison3Adhesiveversusstaples,Outcome5Patientsatisfaction. . . . . . . . . . . . . 113
Analysis3.6.Comparison3Adhesiveversusstaples,Outcome6Timetakenforwoundclosure. . . . . . . . . 113
Analysis4.1.Comparison4Adhesiveversusothermethod,Outcome1Dehiscence. . . . . . . . . . . . . 114
Analysis4.2.Comparison4Adhesiveversusothermethod,Outcome2Infection. . . . . . . . . . . . . 114
Analysis4.3.Comparison4Adhesiveversusothermethod,Outcome3Patientsatisfaction. . . . . . . . . . 115
Analysis4.4.Comparison4Adhesiveversusothermethod,Outcome4Cliniciansatisfaction. . . . . . . . . 116
Analysis4.5.Comparison4Adhesiveversusothermethod,Outcome5Timetakenforwoundclosure. . . . . . 116
Analysis5.1.Comparison5Adhesiveversusadhesive:Highviscosityversuslowviscosity,Outcome1Dehiscence. . 117
Analysis5.2.Comparison5Adhesiveversusadhesive:Highviscosityversuslowviscosity,Outcome2Infection. . . 117
Analysis5.3.Comparison5Adhesiveversusadhesive:Highviscosityversuslowviscosity,Outcome3Patientsatisfaction. 118
Tissueadhesivesforclosureofsurgicalincisions(Review) i
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Analysis 5.4. Comparison 5 Adhesive versusadhesive: High viscosity versus low viscosity, Outcome 4 Clinician
satisfaction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Analysis5.5.Comparison5Adhesiveversusadhesive:Highviscosityversuslowviscosity,Outcome5Timetakenforwound
closure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Analysis 6.1. Comparison 6 Adhesive versus adhesive: octylcyanoacrylate versus butylcyanoacrylate, Outcome 1
Dehiscence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Analysis 6.2. Comparison 6 Adhesive versus adhesive: octylcyanoacrylate versus butylcyanoacrylate, Outcome 2
Infection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Analysis6.3.Comparison6Adhesiveversusadhesive:octylcyanoacrylateversusbutylcyanoacrylate,Outcome3Cosmetic
assessmentratedbypatient(VAS). . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Analysis6.4.Comparison6Adhesiveversusadhesive:octylcyanoacrylateversusbutylcyanoacrylate,Outcome4Cosmetic
assessmentratedbysurgeon(VAS). . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Analysis6.5.Comparison6Adhesiveversusadhesive:octylcyanoacrylateversusbutylcyanoacrylate,Outcome5Surgeon
satisfaction(withdevice). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Analysis6.6.Comparison6Adhesiveversusadhesive:octylcyanoacrylateversusbutylcyanoacrylate,Outcome6Surgeon
satisfaction(withclosure). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Analysis6.7.Comparison6Adhesiveversusadhesive:octylcyanoacrylateversusbutylcyanoacrylate,Outcome7Timetaken
forwoundclosure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
ADDITIONALTABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
WHAT’SNEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
DIFFERENCESBETWEENPROTOCOLANDREVIEW . . . . . . . . . . . . . . . . . . . . . 135
INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Tissueadhesivesforclosureofsurgicalincisions(Review) ii
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
[InterventionReview]
Tissue adhesives for closure of surgical incisions
JoCDumville1,PaulCoulthard2,HelenVWorthington3,PhilipRiley3,NeilPatel4,JamesDarcey2,MarcoEsposito3,Maartenvan
derElst5,OscarJFvanWaes5
1SchoolofNursing,MidwiferyandSocialWork,UniversityofManchester,Manchester,UK.2DepartmentofOralandMaxillofacial
Surgery,SchoolofDentistry,TheUniversityofManchester,Manchester,UK.3CochraneOralHealthGroup,SchoolofDentistry,The
UniversityofManchester,Manchester,UK.4OralSurgery,UniversityDentalHospitalofManchester,Manchester,UK.5Department
ofSurgery,ReinierdeGraafGroep,Delft,Netherlands
Contactaddress:JoCDumville,SchoolofNursing,MidwiferyandSocialWork,UniversityofManchester,Manchester,M139PL,
[email protected].
Editorialgroup:CochraneWoundsGroup.
Publicationstatusanddate:Newsearchforstudiesandcontentupdated(nochangetoconclusions),publishedinIssue11,2014.
Reviewcontentassessedasup-to-date: 12March2014.
Citation: Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJF.
Tissueadhesivesforclosureofsurgicalincisions.CochraneDatabaseofSystematicReviews2014,Issue11.Art.No.:CD004287.DOI:
10.1002/14651858.CD004287.pub4.
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
ABSTRACT
Background
Sutures(stitches),staplesandadhesivetapeshavebeenusedformanyyearsasmethodsofwoundclosure,buttissueadhesiveshave
entered clinical practice more recently. Closure of wounds with sutures enables the closure to be meticulous, but the sutures may
showtissuereactivityandcanrequireremoval.Tissueadhesivesoffertheadvantagesofanabsenceofriskofneedlestickinjuryandno
requirementtoremovesutureslater.Initially,tissueadhesiveswereusedprimarilyinemergencyroomsettings,butthisreviewlooks
attheuseoftissueadhesivesintheoperatingroom/theatrewheresurgeonsareusingthemincreasinglyfortheclosureofsurgicalskin
incisions.
Objectives
To determinethe effectsof various tissue adhesivescomparedwith conventional skin closure techniques forthe closure of surgical
wounds.
Searchmethods
InMarch2014forthissecondupdatewesearchedtheCochraneWoundsGroupSpecialisedRegister;TheCochraneCentralRegister
of ControlledTrials (CENTRAL)(TheCochrane Library);OvidMEDLINE; Ovid MEDLINE (In-Process &OtherNon-Indexed
Citations);OvidEMBASEandEBSCOCINAHL.Wedidnotrestrictthesearchandstudyselectionwithrespecttolanguage,dateof
publicationorstudysetting.
Selectioncriteria
Onlyrandomisedcontrolledtrialswereeligibleforinclusion.
Datacollectionandanalysis
Weconductedscreeningofeligiblestudies,dataextractionandriskofbiasassessmentindependentlyandinduplicate.Weexpressed
resultsasrandom-effectsmodelsusingmeandifferenceforcontinuousoutcomesandriskratios(RR)with95%confidenceintervals
(CI)fordichotomousoutcomes.Weinvestigatedheterogeneity,includingbothclinicalandmethodologicalfactors.
Tissueadhesivesforclosureofsurgicalincisions(Review) 1
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Mainresults
Thissecondupdateofthereviewidentified19additionaleligibletrialsresultinginatotalof33studies(2793participants)thatmet
theinclusioncriteria.Therewaslowqualityevidencethatsuturesweresignificantlybetterthantissueadhesivesforreducingtheriskof
woundbreakdown(dehiscence;RR3.35;95%CI1.53to7.33;10trials,736participantsthatcontributeddatatothemeta-analysis).
Thenumberneededtotreatforanadditionalharmfuloutcomewascalculatedas43.Forallotheroutcomes-infection,patientand
operatorsatisfactionandcost-therewasnoevidenceofadifferenceforeithersuturesortissueadhesives.Noevidenceofdifferenceswas
foundbetweentissueadhesivesandtapesforminimisingdehiscence,infection,patients’assessmentofcosmeticappearance,patient
satisfactionorsurgeonsatisfaction.Howevertherewasevidenceinfavourofusingtapeforsurgeons’assessmentofcosmeticappearance
(meandifference(VAS0to100)9.56(95%CI4.74to14.37;2trials,139participants).Onetrialcomparedtissueadhesiveswith
avarietyofmethodsofwound closureandfoundboth patientsandcliniciansweresignificantly moresatisfiedwith thealternative
closuremethodsthantheadhesives.Thereappearedtobelittledifferenceinoutcomefordifferenttypesoftissueadhesives.Onestudy
thatcomparedhighviscositywithlowviscosityadhesivesfoundthathighviscosityadhesiveswerelesstime-consumingtousethanlow
viscositytissueadhesives,butthetimedifferencewassmall.
Authors’conclusions
Suturesaresignificantlybetterthantissueadhesivesforminimisingdehiscence.Insomecasestissueadhesivesmaybequickertoapply
thansutures.Althoughsurgeonsmayconsidertheuseoftissueadhesivesasanalternativetoothermethodsofsurgicalsiteclosurein
theoperating theatre,theyneedtobe awarethatsuturesminimise dehiscence.Thereisaneedformore welldesignedrandomised
controlledtrialscomparingtissueadhesiveswithalternativemethodsofclosure.Thesetrialsshouldincludepeoplewhosehealthmay
interferewithwoundhealingandsurgicalsitesofhightension.
PLAIN LANGUAGE SUMMARY
Tissueadhesivesforclosureofsurgicalskinincisions
Tissueadhesivesorgluesareincreasinglyusedinplaceofstitches(sutures)orstaplestoclosewounds.Ithasbeensuggestedthattissue
adhesivesmaybequickerandeasiertousethansuturesforclosingsurgical wounds. Tissue adhesivescarrynoriskofsharpsinjury
-unlikeneedlesthatareusedforsutures-andarethoughttoprovideabarriertoinfection.Thismaymeanthattheyalsopromote
healing,andtheneedforremovalofsuturesisavoided.
TheresearcherssearchedthemedicalliteratureuptoMarch2014,andidentified33medicalstudiesthatinvestigatedtheuseoftissue
adhesivesforclosureofwounds.Theycomparedtissueadhesivewithanothermethodofclosuresuchassutures,staples,tape,oranother
typeoftissueadhesive.Themainoutcomesofinterestwerewhetherwoundsstayedclosed-anddidnotbreakdown-andwhether
theybecameinfected.Theresultsofthereviewshowedclearlythatfewerwoundsbrokedownwhensutureswereused.Studiesalso
reportedthatsometypesoftissueadhesivesmightbeslightlyquickertousethanothertypes.Therewasnocleardifferencebetween
tissueadhesivesandthealternativeclosuremethodsforcosmeticresultsorcosts.Resultsregardingsurgeons’andpatients’preferred
skinclosuremethodweremixed.
Tissueadhesivesforclosureofsurgicalincisions(Review) 2
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
CopTiss SUMMARY OF FINDINGS FOR THE MAIN COMPARISON [Explanation]
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Collaborgicalin Outcomes Illustrativecomparativerisks*4(95%CI) Relativeeffect Noofparticipants Qualityoftheevidence Comments
ratiocisio (95%CI) (studies) (GRADE)
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38per1000 76per1000
(14to397)
Moderate
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BACKGROUND Whyitisimportanttodothisreview
Itisimportantthatclinicaldecision-makersareabletomakeevi-
dence-informeddecisionsregardingtheuseoftissueadhesivesto
Descriptionofthecondition closesurgicalincisions. Thisreviewwasfirstpublishedin2004.
Astissueadhesivesbecomemorewidelyused,morerandomised
Millionsofsurgical proceduresareconductedaroundtheworld
controlledtrialsareconducted,andthisupdateisrequiredtoin-
eachyear.Themajority of proceduresresultinsurgical wounds
corporatethisnewevidence.
thatwillhealbyprimaryintention-thisiswherewoundedgesare
broughttogether(re-approximated)andheldtogether,e.g.with
sutures,tofacilitatetissuehealing.
OBJECTIVES
Descriptionoftheintervention Todeterminetheeffectsofvarioustissueadhesivescomparedwith
conventional skin closure techniques for the closure of surgical
Inthepasttheoptionsforwoundclosurehavebeenlimitedlargely
wounds.
tosutures(needleandthread)withotheralternativessuchassta-
ples,adhesivetapesandtissueadhesivesenteringclinicalpractice
morerecently.Closureofwoundswithsuturesenablesmeticulous
closure, but skin may react to sutures and they usually require METHODS
removal.Tissueadhesives(glues)offertheadvantagesthatsuture
removalisnotrequiredatalaterdateandthereisnoriskofneedle-
stickinjurytothesurgeonorassistant. Criteriaforconsideringstudiesforthisreview
Tissueadhesiveshavebeenusedinvariousformsformanyyears
since the first cyanoacrylate adhesives were synthesised (Coover
1959).Theearlyadhesiveswereappropriateforsmallsuperficial
Typesofstudies
lacerationsandincisions,buttheirlimitedphysicalpropertiespre-
Randomisedcontrolledtrials(RCTs).
venteduseinthemanagementofotherwounds.Therewerealso
reports of acute and chronic inflammatory reactions (Houston
1969).Furtherdevelopmentledtotheintroduction ofthen-2- Typesofparticipants
butylcyanoacrlyatesthatwerepurerandstronger,butdidnotre-
Peopleofanyageandinanysettingrequiringclosureofasurgical
ceive widespread acceptance because their clinical performance
skinincisionofanylength.
was limited by their low tensile strength and brittleness (Bruns
1996;Quinn1993).Morerecentlystrongertissueadhesiveshave
beendevelopedbycombiningplasticisersandstabiliserstoincrease Typesofinterventions
flexibilityandreducetoxicity(Quinn1997).
Surgicalskinincisionclosurewithtissueadhesivecomparedwith
Tissueadhesiveshavebeenusedprimarilyinemergencyroomsand
another tissue adhesive or any alternative conventional closure
thereisincreasingsupportintheliteraturefortheireffectivenessin
devicesuchassutures,staplesoradhesivetapes(e.g.Steri-Strips/
theclosureofvarioustraumaticlacerations(Farion2001;Osmond
butterflystitches).
1999;Perron2000;Quinn1997).Surgeonsnowalsousetissue
adhesives in the operating room for the closure of surgical skin
incisions. Typesofoutcomemeasures
Primaryoutcomes
Howtheinterventionmightwork
Proportionofwoundsthatbreakdown(wound
•
Theintroductionoftissueadhesiveswasreceivedenthusiastically dehiscence).
as they may produce equivalent tensile strength, improved cos-
meticappearanceofthescarandalowerinfectionratewhencom-
paredwithsutures,staplesandadhesivetapes,whileavoidingmany Secondaryoutcomes
of the risks and disadvantages of alternative methods (Osmond Proportionofinfectedwounds(usingthestudy
•
1999).Aswithstandardadhesives,tissueadhesivesareappliedto investigator’sdiagnosisofinfection).
thewoundinaliquidform-followingapplicationtheyundergo Cosmeticappearanceatorafterthreemonthswherethe
•
polymerisationandbondingandsettingoccurs. investigatorhasusedavalidatedmeasure.
Tissueadhesivesforclosureofsurgicalincisions(Review) 5
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Patient(orinthecaseofstudiesperformedwith #13MeSHdescriptor:[Acrylates]explodealltrees1757
•
participantsundertheageof16years,parents’)general #14acrylate*254
satisfactionwithskinincisionclosuretechnique(thisismore #15MeSHdescriptor:[Bucrylate]explodealltrees0
thancosmeticappearanceasotherfactorssuchassutureremoval #16bucrylate*6
experiencemayhaveaninput). #17#4or#5or#6or#7or#8or#9or#10or#11or#12or#
Surgeonsatisfactionwithskinincisionclosuretechnique 13or#14or#15or#162397
•
(thismaytakeintoaccountthetimeforsurgeontocloseskin #18#3and#17225
incisionamongstotherfactors). ThesearchstrategiesforOvidMEDLINE,OvidEMBASEand
Relativecostofmaterialsrequiredfortheskinincision Ovid CINAHL can be found in Appendix 3, Appendix 4 and
•
closuretechniquesbeingcompared(thiswillbereportedina Appendix5respectively.TheOvidMEDLINEsearchwascom-
narrativeform). bined with the Cochrane Highly Sensitive Search Strategy for
Timetakentowoundclosure(atendofsurgery)hasbeen identifyingrandomisedtrialsinMEDLINE:sensitivity-andpre-
•
addedtothereviewasaposthocoutcomemeasure.Thereview cision-maximizing version(2008revision); (Lefebvre2011).We
authorsbelievethistobeacontributoryfactortowardsboth combinedtheEMBASEsearchwiththeOvidEMBASEfilterde-
cost-effectivenessandsatisfaction. velopedbytheUKCochraneCentre(Lefebvre2011).Wecom-
binedtheCINAHLsearcheswiththetrialfiltersdevelopedbythe
ScottishIntercollegiateGuidelinesNetwork(SIGN2011).
Searchmethodsforidentificationofstudies
Foranoutlineofthesearchmethodsusedintheoriginalversion Searchingotherresources
ofthisreviewseeAppendix1 Thereviewerscheckedthebibliographiesofnewstudiesincluded
Foranoutlineofthesearchmethodsusedinthefirstupdateof inthisupdatedreviewforpotentiallyeligiblereferencesthathad
thisreviewseeAppendix2. notbeenidentifiedintheelectronicsearchesoutlinedabove.
Electronicsearches
Datacollectionandanalysis
ForthissecondupdateinMarch2014wesearchedthefollowing
electronicdatabases:
CochraneWoundsGroupSpecialisedRegister(searched13
• Selectionofstudies
March2014);
TheCochraneCentralRegisterofControlledTrials Two review authors independently examined the titles and ab-
•
(CENTRAL;TheCochraneLibrary2014Issue1); stractsofallthearticlesidentifiedbythesearchtoidentifypoten-
OvidMEDLINE (1946toMarchWeek12014); tially relevanttrials and thenassessed the full textof these arti-
• OvidMEDLINE(In-Process&OtherNon-Indexed clesindependentlyusingastandardisedformtocheckforeligibil-
Cit•ations,12March2014); ityinthereview.Disagreementsaboutinclusionwereresolvedby
OvidEMBASE(1974to12March2014); consensusorafurtherreviewauthorwherenecessary.Tworeview
• EBSCOCINAHL(1982to13March2014). authorsperformedvalidityassessmentanddataextractiononall
• studiesmeetingtheinclusioncriteria.Studiesrejectedatthisstage
ThefollowingstrategywasusedtosearchtheCochraneCentral
wererecordedinatableofexcludedstudiesandreasonsforexclu-
RegisterofControlledTrials(CENTRAL):
sionrecorded.
#1 MeSH descriptor: [Wounds and Injuries] explode all trees
15958
#2surgicalnextwound*3679 Dataextractionandmanagement
#3#1or#219357 Datawereextractedbyatleasttworeviewauthorsindependently
#4MeSHdescriptor:[TissueAdhesives]explodealltrees387 usingspeciallydesigneddataextractionforms.Thedataextraction
#5 MeSH descriptor: [Fibrin Tissue Adhesive] explode all trees forms were piloted on several papers and modified as required
329 before use. Any disagreements were resolved by discussion and
#6tissuenextadhesive*655 thirdreviewauthorconsultedwherenecessary.Allstudyauthors
#7MeSHdescriptor:[Cyanoacrylates]explodealltrees154 werecontactedforclarification,ortorequestmissinginformation
#8octylcyanoacrylate*52 wherenecessary.Datawereexcludediffurtherclarificationcould
#9Dermabond44 notbeobtained.
#10MeSHdescriptor:[Enbucrilate]explodealltrees42 Foreachtrialthefollowingdatawererecorded:
#11enbucrilate62 yearofpublication,countryoforiginandsourceofstudy
•
#12butylcyanoacrylate*7 funding;
Tissueadhesivesforclosureofsurgicalincisions(Review) 6
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
detailsoftheparticipantsincludingdemographic Thereviewersintendedtometa-analysetheresultsoftrialswith
•
characteristicsandcriteriaforinclusion; asplitwound(differentpartsofthesamewoundrandomisedto
detailsofthetypeofintervention(adhesive,suture,staples alternatetreatments),andsplitbodydesigns(differentwoundson
•
oradhesivetape)andtypeofadhesive(butylcyanoacrylateor thesameparticipantrandomisedtoalternativetreatments)using
octylcyanoacrylate); the inverse variance method for paired data if appropriate data
detailsoftheoutcomesreported,includingmethodof wereavailable.
•
assessmentandtimeintervals.Cosmeticappearancewasincluded
iftheauthorsstatedthatwasmeasuredonavalidatedscale.
’Summaryoffindings’tables
Assessmentofriskofbiasinincludedstudies Inthissecondupdatewealsopresentthemainresultsofthereview
in’Summaryoffindings’tables.Thesetablespresentkeyinforma-
Tworeviewauthorsindependentlyassessedeacheligiblestudyfor
tionconcerningthequalityoftheevidence,themagnitudeofthe
riskofbiasusingtheCochrane‘Riskofbiasassessmenttool’.The
effectsoftheinterventionsexamined,andthesumoftheavailable
tooladdressessixspecificdomains(seeAppendix6),namelyse-
dataforthemainoutcomes(Schunemann2011a).The’Summary
quencegeneration,allocationconcealment,blinding,incomplete
offindings’tablesalsoincludeanoverallgradingoftheevidence
outcome data,selectiveoutcome reportingandotherissuesthat
relatedtoeachofthemainoutcomesusingtheGRADE(Grades
maypotentiallybiasthestudy(Higgins2011).Theycompleteda
ofRecommendation,Assessment,DevelopmentandEvaluation)
‘Riskofbias’tableforeacheligiblestudy,andaseparateassessment
approach.TheGRADEapproachdefinesthequalityofabodyof
ofblindingandcompletenessofoutcomedataforeachoutcome.
evidenceastheextenttowhichonecanbeconfidentthatanesti-
Discrepanciesbetweenreviewauthorswereresolvedthroughdis-
mateofeffectorassociationisclosetothetruequantityofspecific
cussion.Findingsarepresentedusingthe‘Riskofbias’summary
interest.Thequalityofabodyofevidenceinvolvesconsideration
figure,whichpresentsallofthejudgementsinacross-tabulation
ofwithin-trialriskofbias(methodologicalquality),directnessof
ofstudybyriskofbiasdomain.
evidence, heterogeneity,precision of effectestimates andrisk of
publicationbias(Schunemann2011b).Wepresentthefollowing
Assessmentofheterogeneity outcomesinthe’Summaryoffindings’tables:
Thisassessmentofclinicalandmethodologicalheterogeneitywill wounddehiscence;
•
besupplementedbyinformationregardingstatisticalheterogene- woundinfection.
•
ity-assessedusingtheChi²test(asignificancelevelofPlessthan
0.10willbeconsideredtoindicatestatisticallysignificanthetero-
geneityinconjunctionwithI²measure;Higgins2003).I²exam- Subgroupanalysisandinvestigationofheterogeneity
inesthepercentageoftotalvariationacrossRCTs thatisdueto
Thereviewersintendedtoundertakeasubgroupanalysisof age
heterogeneityratherthanchance.IngeneralI²valuesof25%,or
(under 18 years and 18 years or older), location of incision on
less,maymeanalowlevelofheterogeneity,andvaluesof75%,or
body(faceandbody),lengthofincision(lessthan4cmand4cm
more,indicateveryhighheterogeneity(Deeks2011).
orgreater),andpatientcharacteristicssuchasdiabetesandsource
oftrialfunding(commerciallyorindependentlyfunded),however
Datasynthesis therewereinsufficient studiesreportingthesedatatoundertake
theseanalyses.
Fordichotomousoutcomes,thereviewersusedriskratios(RR)to
expressestimatesofeffectofanintervention,togetherwith95%
confidenceintervals(CI).Forcontinuousoutcomes,thereviewers
Sensitivityanalysis
usedmeandifferencesandstandarddeviationstosummarizethe
dataforeachgroup.Wheretherewerestudiesofsimilarcompar- Wherepossibleweplannedtoundertakeasensitivityanalysisto
isonsreportingthesameoutcomemeasures,weattemptedameta- examinetheeffectofrandomisation,allocationconcealmentand
analysis. Risk ratios were combined for dichotomous data, and blindedoutcomeassessmentontheoverallestimatesofeffect.In
weightedmeandifferences(WMD)forcontinuousdata,usinga addition, we also planned a sensitivity analysis to examine the
random-effectsmodel(indicatedasREintheresultssection)as effectofincludingunpublishedliteratureonthereview’sfindings.
someheterogeneitybetweenstudieswasanticipated.Weplanned Inthissecondupdateofthereviewweconductedapost-hocsen-
to analyse time taken to close wound (after surgery) as survival sitivityanalysiswhereweremovedstudiesfromkeyanalyseswhere
(time-to-event)data,usingtheappropriateanalyticalmethod(as wehadconcernsaboutpossibleunitofanalysisissues(i.e.where
pertheCochraneReviewers’Handbook guidance Deeks2011), dehiscence and infection had been recorded over multiple time
or as a continuous outcome, if data from all participants were periodsanditwasnotclearfromtheanalyseswhethersomepar-
available. ticipantshadmorethanoneevent).
Tissueadhesivesforclosureofsurgicalincisions(Review) 7
Copyright©2014TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.