Abstract!of!thesis!entitled! - University of Hong Kong Wai Ching.pdf · ! 5!...
Transcript of Abstract!of!thesis!entitled! - University of Hong Kong Wai Ching.pdf · ! 5!...
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Abstract!of!thesis!entitled!
“Evidence)based-guidelines-on-tap-water-irrigation-for-patients-
presenting-to-accident-and-emergency-department-with-simple-
acute-traumatic-lacerations”-
Submitted!by!!
Lam-Wai-Ching-
For!the!degree!of!Master!of!Nursing!
at!the!University!of!Hong!Kong!
in!August!2015!
!
Abstract! !
Simple!acute!traumatic!lacerations!refer!to!a!type!of!skin!injuries,!which!is!
the! most! common! reason! that! patients! attend! Accident! and! Emergency!
Departments! (AEDs).! Nurses! play! the! role! in! choosing! dressing! solutions! for!
wound!management! although!wound!management! varied! in! local! AEDs.! Using!
tap!water!for!irrigation!is!a!cost!effective!method!for!wound!management.!There!
is!no!difference!between!using!tap!water!and!normal!saline!irrigation!in!infection!
rates!according!to!latest!evidence.!However,!there!is!currently!no!local!studies!or!
evidenceLbased!guidelines!using!tap!water!for!irrigation!in!Hong!Kong.!The!aim!
of!this!dissertation!is!to!find!out!latest!evidence!and!develop!an!evidenceLbased!
protocol!of!using!tap!water!for!irrigation!in!local!AEDs.!
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Four! electronic! bibliographical! databases! including! PubMed,! CINAHL,!
Medline!(OvidSP)!and!Cochrane! library!were!used!and! four! latest!studies!meet!
the! inclusion! criteria! in! this! dissertation.! And! the! studies! were! evaluated! by!
using!Scottish!Intercollegiate!Guideline!Network!(SIGN),!which!is!an!assessment!
tool!to!evaluate!the!studies!quality.!!
The!result!of!the!findings!suggested!there!is!no!difference!between!using!
tap!water!and!normal!saline!for!irrigation!in!infection!rates.!Using!tap!water!as!
an! alternative! for! wound! irrigation! in! AEDs! poses! benefits! to! patients,! health!
care! professionals! and! whole! health! care! systems! in! the! long! run.! The!
implementation!potential!will!be!assessed!in!terms!of!transferability,!feasibility,!
and! costLbenefit! analysis.! In! addition,! an! evidenceLbased! guideline! was!
established!for!local!AEDs.!
!! After! assessing! the! implementation! potential,! it! is! necessary! to!
communicate!with!various!stakeholders.!The!pilot!study!will!be!performed!and!
evaluation! will! be! done.! The! evaluation! includes! patient! outcome,! healthcare!
provider! outcome! and! organization! outcome.! The! proposed! innovation!will! be!
regarded! as! a! success! if! there! is! no! difference! between! using! tap! water! and!
normal!saline!for!irrigation!in!infection!rates.!!
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Evidence)based-guidelines-on-tap-water-irrigation-for-patients-
presenting-accident-and-emergency-department-with-simple-
acute-traumatic-lacerations-
By!!
Lam!Wai!Ching!
BN,!RN!
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A!thesis!submitted!in!partial!fulfillment!of!the!requirements!for!
the!Degree!of!Master!of!Nursing!
at!the!University!of!Hong!Kong!
August,!2015!
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Declaration!
I! declare! that! this! thesis! represents! my! own! work,! except! where! due!
acknowledgement! is! made,! and! that! it! has! not! been! previously! included! in! a!
thesis,! dissertation! or! report! submitted! to! this! University! or! to! any! other!
institution!for!a!degree,!diploma!or!other!qualifications.!!
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Lam!Wai!Ching!
August,!2015!
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Acknowledgement--
I!would!like!to!express!my!gratitude!to!my!supervisors,!Dr.!Janet!Wong!Yuen!Ha,!
Assistant! Professor! and! Director! of! Master! of! Nursing! Programme,! for! her!
guidance!and!support.!I!would!like!to!thank!Dr.!Kelvin!Wang!Man!Ping,!Assistant!
Professor,! for! his! assistance,! opinions,! and! encouragement.! This! dissertation!
could!not!have!been!completed!without! their!support,!especially! I!encountered!
critical!period!in!2013L2015.!!
In! addition,! I! would! like! to! thank! all! my! AEDs! colleagues! and! family!
members! for! their! understanding,! kindness! and! generosity! throughout! my!
studies.!!
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Content!Abstract! ! ! ! ! ! ! ! ! ! !!!1!Declaration!! ! ! ! ! ! ! ! ! !!!4!Acknowledgement! ! ! ! ! ! ! ! !!!5!!Chapter!1!Introduction!1.1!Background!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!7!1.2!Affirming!the!needs!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!8!!!!!!!!!!!!!!!!1.3!Significance!and!objectives!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!9!!Chapter!2!Critical!Appraisals!2.1!Search!and!Appraisal!strategies!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!12!2.2!Results!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!13!2.3!Summary!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!17!2.4!Synthesis!of!findings!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!18!!Chapter!3!Translations!and!Application!3.1!Implementation!potential!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!20!3.2!Feasibility!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!21!3.3!CostLbenefit!ratio!of!the!innovation!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!25!3.4!EvidenceLbased!practice!guideline!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!28!!Chapter!4!Implementation!plan!4.1!Communication!plan!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!29!4.2!Pilot!study!plan!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!31!4.3!Evaluation!plan!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!33!! ! ! ! ! ! ! ! !!Reference!list!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!38!Appendix!ALR!
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Chapter-1-
Introduction-
1.1-Background-
Acute!traumatic!lacerations!defined!as!a!type!of!skin!injuries!in!which!the!
topmost! layer! is!scratched!off.!This! is!a!common!reason!that!people!present! to!
Accident! and! Emergency! Departments! (AEDs),! requiring! wound! dressing! and!
suturing.! It! accounts! for! 8L17%! of! all! emergencies! in! United! States! (US),! and!
approximately!8!million!traumatic!wound!every!year!(Weiss!et!al.,!2013;!Moscati!
et! al.,! 2007;!Zehtabchi!et! al.,! 2012).! Some!with!minor! skin! injuries!may!handle!
the!wounds!by!themselves!instead!of!seeking!medical!cares.!This!implies!that!the!
actual! number! of! skin! injuries! is! much! more! than! estimation.! Many! of! skin!
lacerations! occur! in! children! and! the! occurrences! more! likely! in! males! than!
females!(Weiss!et!al.,!2013;!Valente!et!al.,!2003;!Bansal!et!al.,!2002).!!
Wound!infection!is!the!leading!cause!of!morbidity!and!mortality,!which!is!
associated!with!several!factors,!such!as!the!time!present!to!AEDs,!the!anatomical!
site,!the!type!and!the!amount!microorganisms,!the!medical!status!of!the!patient.!
For! instance,!wound! infection! in!diabetes!mellitus!has!a!poorer!prognosis! than!
others! (Quinn! et! al.,! 2014).! Untreated! wound! with! more! than! 12L24! hours! is!
more! susceptible! to! infections.! Severe! wound! infections! not! only! affect!
functioning! but! also! cosmetic! outcomes! (Fernandez! et! al.,! 2005).! Thus,! great!
effort! was! usually! devoted! by! health! care! professionals! to! reduce! the! risk! of!
infection.!(Weiss!et!al.,!2013;!Quinn!et!al.,!2014;!Fernandez!et!al.,!2005).!!
Using! antiseptics! such! as! povidoneLiodine,! chlorhexidine! for! wound!
cleansing!is!common!but!remain!controversial!as!they!may!impede!normal!tissue!
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growth.! Normal! saline! (NS)! is! the! most! common! solution! used! for! wound!
management!in!the!AEDs!in!Hong!Kong.!NS!is!isotonic,!easily!available!and!cost!
effective!when!compared!with!other!antiseptics!(Weiss!et!al.,!2013;!Moscati!et!al.,!
2007;!Valente!et!al.,!2003;!Bansal!et!al.,!2002).!!
1.2-Affirming-the-Needs-
Wound!management!varied! in!different!AEDs! in!Hong!Kong.!Some!AEDs!
washed!wounds!with!antiseptics!and!some!used!irrigation.!Irrigation!is!a!wound!
dressing!method!to!remove!debris,!devitalized!tissue!and!bacteria!(Weiss!et!al.,!
2013).! Irrigation! was! usually! performed! using! an! 18! gauge! needle! or!
angiocatheter!and!copious!normal!saline!dilution!to!generate!pressure!through!a!
syringe! to! remove! bacteria! and! debris.! Around! 250L300! ml! normal! saline! is!
usually! used! for! irrigation.! The! actual! volume! used! is! dependent! on! the! size,!
depth!of!the!wound!and!the!suggested!pressure!between!8L45!psi!(Dulecki!et!al,!
2005).!!
Nurses! usually! play! the!main! role! in! choosing! the! solutions! for! wound!
irrigation! and! tap! water! is! increasingly! considered! as! another! choice! than!
normal!saline.!Tap!water!was!defined!as!water!that!comes!out!of!the!tap!faucets!
in!a!building!that!are!connected!to!the!main!supply!of! the! local!systems.! It!was!
the!most!common!solutions! for! irrigation!outside!hospitals! for! first!aids!and! in!
the! community! (Fernandez!et! al.,! 2005).! !The!variability!of! irrigation! solutions!
suggests!that!an!evidenceLbased!protocol!for!irrigation!in!AEDs!is!needed.!
Tap! water! is! less! expensive! than! normal! saline! and! other! antiseptics,!
especially!when!plenty!of!solutions! is!needed!for! irrigation.!Weiss!et!al.! (2013)!
estimated!that!using!tap!water! for! irrigation!could!generate!millions!of!savings!
for!the!hospitals,!significantly!further!lowering!the!cost!for!wound!management!
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if!it!is!as!effective!as!normal!saline!in!reducing!infection.!Normal!saline!solutions!
have!shelf!lives!and!expiry!dates.!For!a!bottle!of!1000ml!normal!saline,!it!usually!
needs! to! be! discarded! within! 24! hours! once! open! no! matter! used! up! or! not.!
These! bottles! occupy! significant! space! for! storage.! If! tap! water! is! used! for!
irrigation,! it!may! lower!medical!costs,! space! for!storage!and!hence!reduces! the!
financial! burden! of! society! and! individuals.! And! the! bottles! of! sterile! normal!
saline! can!be!used! in! rural,! poor!developed!area!where!did!not!have! clean! tap!
water! supply! (Weiss! et! al.,! 2013;! Moscati! et! al.,! 2007;! Valente! et! al.,! 2003).!
However,!using!tap!water!for!irrigation!in!the!community!is!common,!but!using!
tap! water! for! irrigation! in! the! AEDs! received! minimal! attention.! In! addition,!
there!are!no!guidelines!on!using!tap!water!for!irrigation!in!local!AEDs.!
Emergency! services! become! an! important! part! of! health! care! systems!
since! the! demand! of! emergencies! service! rises! in! accordance! with! the! rapid!
growing! populations.! In! Hong! Kong,! the! attendance! of! AEDs! is! 2253310!
according! to! Hospital! Authority! statistical! report! in! 2012L2013.! Cost!
management! is! necessary! to! health! care! systems,! especially! to! encounter! the!
challenge!with!growing!populations!and!the!need!of!medical!services.!Hong!Kong!
is!a!wellLdeveloped!country!and!the!medical!standard,!water!quality!are!able!to!
meet! the! standard! of! World! Health! Organization! (WHO).! The! applications! of!
using!tap!water! for! irrigation!pose!benefits! to!not!only!the! local!AEDs,!but!also!
the!whole!health!care!systems!in!Hong!Kong.!!
1.3-Significance-and-Objectives-
As! there! is! a! dearth! of! evidence! on! using! tap! water! to! manage! acute!
traumatic!lacerations!in!the!HK!AEDs,!the!aim!of!this!study!is!to!compare!the!tap!
water! and! normal! saline! on! reducing! infection,! specifically! focuses! on! the!
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effectiveness! of! tap! water! solution! in! managing! of! simple! acute! traumatic!
lacerations!and!to!translate!the!findings!with!justifications!to!manage!traumatic!
wounds! of! patients! present! to! AEDs.! A! new! guideline! or! protocol! of! using! tap!
water!was! then! set!up!according! the!best! available!evidence,! and! translate! the!
finding!to!the!AEDs.!!
Objectives-
1. To!systematic!review!the!existing!literature!on!comparing!tap!water!and!
normal!saline!for!irrigation!in!AEDs!
2. To!critically!appraise! the!existing! literature!of! comparing! tap!water!and!
normal!saline!for!irrigation!in!AEDs!
3. To! gather! empirical! evidence! of! using! tap! water! and! normal! saline!
irrigation! for! patient! present! to! AEDs! with! acute! simple! traumatic!
lacerations.!
4. To!develop!an!evidenceLbased!guideline!for!using!tap!water!for!irrigation!
in!patients!with!acute!simple!traumatic!lacerations!!
5. To!assess!the!implementation!potential!of!using!tap!water!for!irrigation!in!
Hong!Kong!
6. To!evaluate!the!effectiveness!of!using!tap!water!for!irrigation!in!patients!
with!acute!simple!traumatic!lacerations!
!
The!Stetler!model!is!the!evidenceLbased!practice!that!promote!and!facilitates!
critical!thinking!about!the!application!of!research!findings!in!practice.!It!consists!
of! 5! phases:! preparation,! validation,! comparative! evaluation/decision! making,!
translation!and!evaluation!in!Appendix!A.!
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Chapter-2-
Critical-appraisal-
The!background,!affirming!needs,!significance!was!discussed!in!chapter!1,!
the!next!step!is!to!search!and!extract!relevant!evidence!related!to!the!question.!A!
question!was!formulated!using!PICO!format!to!gather!relevant!evidence.!
Questions:! In! patients! with! acute! traumatic! wounds,! is! tap! water! effective! as!
normal!saline!irrigation!in!reducing!infection?!
Patient/Problem:!Patients!attend!AEDs!with!acute!simple!traumatic!lacerations.!!
Intervention:!Tap!water!irrigation!!
Comparison:!Normal!saline!irrigation!
Outcome:!reduced!infection!
Selection-criteria--
All! randomized! controlled! trials,! quasiLrandomized! controlled! trials,! and!metaL
analysis! of! human! studies! that! compared! using! tap! water! and! normal! saline!
irrigation!in!AEDs!was!included.!
Inclusion-criteria--
Patients! attend! AEDs! with! acute! simple! traumatic! lacerations,! with! age! more!
than!1!year!were!included.!
Exclusion-criteria-
Patients! with! underlying! illness! such! as! diabetes,! immune! disease,! cancer,!
current! use! of! antibiotics,! immunosuppressant,! and! complicated! wound! with!
injury! to! tendon,! major! blood! vessels,! attend! AEDs! more! than! 9! hours! were!
excluded.!
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2.1-Search-strategies-
A!systematic! search!was! conducted!between!1! July!2014!and!4!October!
2014.! ! The! databases! of! PubMed,! CINAHL,! Medline! (OvidSP)! and! Cochrane!
library! were! searched.! The! searching! keywords! included! “normal! saline”,!
“lacerations”,! “acute! traumatic! wound”,! “tap! water”! between! 2004! and! 2014!
were! searched! so! as! to! obtain! latest! studies.! However,! only! 2! relevant!
randomized!controlled!trials!and!between!2005!and!2012!were!found.!In!order!
to!gather!the!latest!relevant!studies,!further!searching!was!extended!to!2003!and!
subsequently! to! 1994! so! as! to! capture! the! latest! studies! for! best! available!
evidence.!Those! studies!were! limited! to!English!and!Chinese!with! full! text.!For!
those!without!the!full!text,!the!abstracts!were!screened!for!eligibility.!The!flow!of!
searching!was!shown! in!Appendix!C!with!PRISMA! flow!diagram!(Mocher!et.!al,!
2009).! In!addition,! the!references!of! the!selected!studies!were!also!screened! in!
order! to! extend! the! searching! area! to! obtain! relevant! information.! The! search!
result! is! available! in! Appendix! B.! The! quality! of! the! selected! studies! will! be!
assessed!using!Scottish!Intercollegiate!Guidelines!Network!(SIGN).!!
Data-Extraction-
After! searching! the! relevant! studies,! some! irrelevant! studies! were!
excluded.!The!remaining!were!extracted!and!organized!in!the!table!of!evidence!in!
Appendix!D.!!
2.1-Appraisal-strategies!
Scottish!Intercollegiate!Guidelines!Network!(SIGN)!was!developed!as!a!set!
of!checklists! to!assess!study!quality.! If! the!studies!are!able! to!meet!most!of! the!
criteria!in!the!checklist,!it!will!be!rated!as!high!quality!(++).!!The!searched!studies!
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were! assessed! and! formulated.! All! studies! were! relevant! to! the! key! questions!
and! the! quality! assessment! of! each! study! will! be! shown! in! Appendix! E! to!
Appendix!H.!
2.2-Results-
Research-design-
There! are! four! randomized! controlled! trials! that! are! relevant! to! the!
research! question.! The! remaining!were! screened! and! eliminated! based! on! the!
selection! criteria.! ! Three! trials!were! conducted! in! the!US! (Moscati! et! al.,! 2007;!
Valente!et!al.,!2003;!Bansal!et!al.,!2002)!and!one!trial!was!conducted! in! the!UK!
(Weiss!et!al.,!2013).!No!local!study!was!found!for!using!tap!water!for!irrigation!in!
AEDs.!Three! trials! (Weiss!et! al.,! 2013;!Valente!et! al.,! 2003;!Bansal! et! al.,! 2002)!
conducted!in!single!center!while!one!was!conducted!in!multicenter!(Moscatic!et!
al.,!2007).!!
Weiss! et! al.! (2013)! are! the! latest! double! blind! randomized! controlled!
clinical!trial.!And!this!trial!was!rated!as!high!quality!(++)!since!it!could!meet!most!
of!the!criteria!in!the!checklist!of!SIGN!in!Appendix!2!with!the!detail!description!of!
the!randomization!process.!The!others!(Moscatic!et!al.,!2007;!Valente!et!al.,!2003;!
Bansal!et!al.,!2002)!were!rated!as!acceptable!quality!since!they!only!meet!some!
of!the!criteria!in!the!checklist.!
Randomization-and-allocation-concealment-
Weiss! et! al.! (2013)!used! the! computer! to! randomly! assign!patients! into!
groups! with! adequate! concealment.! Moscatic! et! al.! (2007)! also! used! the!
computer!to!generate!the!sequence!for!randomization!which!was!then!kept!in!an!
envelope.! Participants!would! be! assigned! to! either! tap!water! group! or! normal!
saline!group!by!opening!the!next!envelop.!This!trial!used!convenience!sampling!
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to! enroll! participants,! which! might! undermine! the! representativeness! of! the!
findings.! Valente! et! al.! (2003)! cannot! ensure! adequate! concealment.! Patients!
were!allocated!to!either!normal!saline!or!tap!water!group!based!on!the!odd!and!
even! days! of! the! month.! Random! allocation! and! concealment! is! regarded! as!
inadequate! in! this! trial! and! may! lead! to! selection! bias.! Bansal! et! al.! (2002)!
mentioned! using! a! randomization! schedule!without! detail! information! on! how!
randomization!schedule!was!generated!in!the!trial.!!
Blinding-
Only!Weiss! et! al.! (2013)! can! ensure! double! blinding! among! four! trials.!
Technician!prepared!500!ml!tap!water!or!normal!saline!solution!in!a!bowl,!and!
the!physician!will!use!the!bowl!of!solution!for! irrigation.!Therefore,! the!patient!
and! physician! were! blinded! about! the! solution! used! for! irrigation.! Another!
physician! assessed! the! wound! condition! for! infection! in! followLup! thus! the!
outcome! measure! were! also! blinded.! Blinding! can! be! performed! in! this! trial.!
However,!Moscatic!et!al.!(2007)!and!Valente!et!al.!(2003)!cannot!ensure!blinding!
in! the! trial! since!wounds!were! irrigated! directly! under! the! running!water! tap.!
Patients! and! physicians! know! that! wounds! were! irrigated! with! tap! water! so!
blinding!cannot!be!performed.!!
Intervention-
Weiss! et! al.! (2013)! controlled! the! other! extraneous! variables! like! the!
pressure,! the!volume!of!solution!and!technique!of! irrigation.!Normal!saline!and!
tap!water!were!prepared!in!the!basin!for!irrigation!so!that!the!volume!of!solution!
was!standardized.!However,!not!all!the!extraneous!variables!were!controlled!in!
this!trial.!!For!example,!the!temperature!of!tap!water!and!normal!saline!was!not!
controlled.! The! technique! of! irrigation! and! volume! of! solution! was! not!
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standardized!in!Moscatic!et!al.!(2007).!Plastic!tubing!was!connected!to!the!tap!of!
the! faucet!and! the!handle!was! turned! to! the!preset!position! to! standardize! the!
pressure!and!flow!rates!in!Valente!et!al.!(2003).!But!the!time!and!temperature!of!
irrigation! was! not! controlled! in! this! trial.! Both! tap! water! and! normal! saline!
groups!used!a!syringe! to!generate!pressure!between!25L40!psi! for! irrigation! in!
Bansal!et!al.!(2002).!
Sample-size-
Weiss!et!al.!(2013)!estimated!adequate!sample!sizes!with!power!analysis.!
The!mean! age,!mechanism! of! injury,! anatomical! site,! and! length! of! the!wound!
were!well! presented! in! the! trial.! The! sample! size! is! adequate! and! the! attrition!
rate! is! small! (1%).! In! Moscatic! et! al.! (2007),! the! sample! size! is! adequate! and!
there! are! approximately! 10%! lost! to! followLup.! The! attrition! rate! is! 7.5%! in!
Valente!et!al.!(2003).!The!attrition!rate! is!similar! in!both!normal!saline!and!tap!
water!irrigation!groups!in!all!trials.!However,!all!trials!did!not!mention!the!use!of!
intention!to!treat!principle!for!data!analysis.!
Study-populations-
The!study!populations! in! four!randomized!controlled! trials!were!mainly!
in!the!US!(Moscati!et!al.,!2007;!Valente!et!al.,!2003;!Bansal!et!al.,!2002)!and!UK!
(Weiss!et!al.,!2013).!
Number-of-participants--
!The!number!of!participants!ranged!from!46!to!715.!Moscati!et!al.!(2007)!
and!Weiss! et! al.! (2013)! estimated! the! sample! size! and! power! of! 80%! before!
having!the!study.!But!the!power!is!insufficient!in!Moscati!et!al.!(2007).!Two!trials!
did!mention! having! sample! size! estimation! (Valente! et! al.,! 2003;! Bansal! et! al.,!
2002).! All! trials! recruited! participants! within! a! period! ranged! from! 14L18!
! 16!
months!with!adequate!sample!size.!The!sample!size!is!small!(n=46)!in!Bansal!et!
al.!(2002).!
Wound-characteristics--
All! trials! recruited! participants!with! simple! acute! traumatic!wound! and!
had!wound!management! in!AEDs.!Two!trials! (Weiss!et!al.,!2013;!Moscati!et!al.,!
2007)!enrolled!participants!with!age!more!than!1!year!while!two!trials!(Valente!
et!al.,!2003;!Bansal!et!al.,!2002)!enrolled!pediatric!patients!with!age!between!1!
and!17.!Patients!with!complicated!wounds!such!as!bite!wound,!extension!deep!to!
tendons!were!excluded!in!all!trials.!All!anatomic!sites!of!lacerations!such!as!face,!
trunk,! upper! and! lower! extremities,!were! included! in! three! trials! (Weiss! et! al.,!
2013;!Moscati!et!al.,!2007;!Bansal!et!al.,!2002).!Hand!lacerations!were!excluded!
in!Valente!et!al.!(2003).!
Intervention-and-duration--
All!patients!received!tropical!or!local!anesthesia!for!pain!relief!during!the!
procedures.!A!35!ml!syringe!and!500!ml!of!either!normal!saline!or!tap!water!was!
used! for! irrigation! (Weiss! et! al.,! 2013;! Bansal! et! al.,! 2002).! The! pressure! of!
irrigation! is! more! than! 8! psi! in!Weiss! et! al.,! (2013)! and! between! 25L40psi! in!
Bansal!et!al.,!(2002).!Wounds!were!irrigated!with!running!tap!water!for!at!least!2!
minutes! in!Moscati! et! al.! (2007).!Wounds!were! irrigated!with! tap!water! for! a!
minimum! of! 10! seconds! in! Valente! et! al.! (2003).! Physicians! then! closed! the!
wound! by! suture! and! patients! will! have! followLups! for! wound! assessment.!
(Weiss!et!al.,!2013;!Moscati!et!al.,!2007;!Valente!et!al.,!2003;!Bansal!et!al.,!2002).!
Follow-up-
All! participants! receiving! either! tap! water! or! normal! saline! irrigation!
received!also!followLup!within!48!hours!to!30!days!to!assess!signs!and!symptoms!
! 17!
of! infection! by! physicians! or! nurses.! Patients! lost! to! followLup! will! further!
contacted!by!phone!calls.!
2.3-Summary-
Outcome-measures-
The!outcome!measures!of!all! trials!are! infection!rate.!Three!randomized!
controlled!trials!(Weiss!et!al.,!2013;!Moscati!et!al.,!2007;!Bansal!et!al.,!2002)!and!
one! quasiLexperimental! trial! (Valente! et! al.,! 2003)! have! subjective! outcome!
measurements,! which! included! assessment! of! the! wound! infection!
characteristics.!Only!Bansal!et!al.!(2002)!included!the!objective!measurement!of!
infection!by!the!bacterial!count!and!wound!culture!result.!!
Effect-size--
The!overall!infection!rate!is!4.9%!in!Weiss!et!al.!(2013).!The!infection!rate!
was! 6.4%! in! normal! saline! group! and! 3.5%! in! tap!water! irrigation! group.! The!
difference! (2.9%)!was! not! statistically! significant.! In!Moscati! et! al.! (2007),! the!
infection! rates! of! normal! saline! group! and! tap!water! group! are! 3.3%! and! 4%!
respectively,!the!difference!between!two!groups!is!0.7%,!which!also!showed!no!
statistical! significance.!Valente!et!al.! (2003)!and!Bansal!et!al.! (2002)!compared!
tap!water!and!normal!irrigation!in!pediatric!patients.!The!result!showed!that!no!
statistically! different! between! two! groups! in! pediatric! patients.! The! infection!
rates!of! normal! saline! and! tap!water! group!are!2.8%!and!2.9%!respectively! in!
Valente!et!al.!(2003).!The!infection!rates!of!normal!saline!and!tap!water!are!8.3%!
and!9.5%!respectively!in!Bansal!et!al.!(2002).!All!4!trials!reported!that!there!is!no!
difference! between!using! tap!water! or! normal! saline! for! irrigation! in! infection!
rates.!
! 18!
Although! the! quality! of! the! above! studies! varied! from! high! quality! to!
(Weiss!et!al.,!2013)!acceptable!quality!(Moscati!et!al.,!2007;!Valente!et!al.,!2003;!
Bansal!et!al.,!2002),!all!trials!suggested!that!using!tap!water!irrigation!as!effective!
as! normal! saline! for! irrigation,! there! is! no! difference! between! normal! saline!
irrigation!and!tap!water!irrigation!in!infection!rates.!The!cost!of!using!tap!water!
for! irrigation! is! lower! than! the!normal! saline!and!evidenceLbased!guidelines!of!
using!tap!water!is!needed!(Dulecki!et!al,!2005).!
2.4-Synthesis-of-findings-
The!difference!of!infection!rates!varied!from!0.1!to!2.9%!in!four!trials.!The!
variation! might! attribute! to! the! study! design,! extraneous! variables! like! the!
anatomical! site! of! the!wound,! irrigation! technique.! Judicious! study! design! can!
enhance! internal! validity,! which! implies! the! outcome! was! caused! by! the!
intervention!instead!of!extraneous!factors.!Random!assignment!and!blinding!can!
be!performed!in!Weiss!et!al.!(2013)!and!Bansal!et!al.!(2002).!The!internal!validity!
of!Moscati! et! al.! (2007)!and!Valente!et! al.! (2003)! lowered!when!blinding!were!
not! be! performed.! In! Moscati! et! al.! (2007),! convenient! sampling! was! used! to!
enroll! subjects! and! allocation! concealment! cannot! be!performed!which! lead! to!
selection!bias,!that!also!affect!the!representativeness!of!the!results.!- -!
In! Valente! et! al.! (2003),! foot! lacerations! are!more! prone! to! infection! if!
irrigated!with!tap!water!and!the!number!of! foot!wounds!was!small! in!pediatric!
patients.! More! hand! wounds! were! assigned! into! tap! water! group.! Hand!
lacerations!were!excluded!and! facial!wounds!were! less! infected! in!Bansal!et!al.!
(2002)!and!the!reason!of!hand!laceration!exclusion!was!not!clearly!stated!in!the!
trial.!Based!on!the!findings!of!the!above!two!trials!(Valente!et!al.,!2003;!Bansal!et!
al.,!2002),!suggested!that!the!anatomical!site!can!be!an!extraneous!variable!that!
! 19!
affect!infection!rate,!especially!in!the!pediatric!patients,!as!discussed!in!chapter!1.!
In! addition,! the! outcome! measures! of! four! trials! are! signs! and! symptoms! of!
infection,!which!is!a!subjective!assessment,!may!impose!bias!in!results.!
Bansal! et! al.! (2002)! suggested!using!wound! culture! results,! or! bacterial!
counts!for!outcome!measures.!Positive!culture!result!was!29%!in!normal!saline!
group! and!52%! in! tap!water! group! that!was!not! significantly! different! in! both!
groups.! However,! the! sample! size! is! small! (n=46)! and! Bansal! et! al.! (2002)!
suggested! further!validation! is!needed!for!using!wound!culture!as! the!outcome!
measure.!
Controlling!the!pressure,!volume!and!irrigation!technique!is!essential!for!
tap! water! irrigation! for! acute! traumatic! lacerations.! The! pressure! should! be!
within!8L45!psi!and!the!irrigation!solutions!should!be!prepared!in!the!basins!and!
a! 35L60!ml! syringe!was! used! for! irrigation! so! as! to! standardize! the! irrigation!
technique.!!
To! summarize,! tap! water! is! as! effective! as! normal! saline! for! irrigation!
based! on! existing! evidence! although! there! is! no! local! study! comparing!normal!
saline! and! tap!water.! According! to!water! supply! department! in! Hong! Kong,! it!
states! that! the! water! quality! comply! with! the! guidelines! of! World! Health!
Organization!(WHO).!It!is!safe!to!drink!and!similar!to!the!standard!of!the!United!
States!and!Western!countries.!Water!samples!were!taken!from!time!to!time!for!
checking! so!as! to!make!sure! that! the! tap!water! supply! is! safe! for! consumption!
and!the!cost! is! lower!than!normal!saline.!There! is!no!clinical!guideline!of!using!
tap!water! for! irrigation! in!HK!AEDs,! so! a! clinical! guideline!was! set! up! and! the!
implementation!plan!will!be!further!discussed!in!next!chapter.!!
-
! 20!
Chapter-3-
Translation-and-Application-
3.1-Implementation-potential-
-- The!literature!review!in!the!previous!chapter!showed!that!tap!water!is!as!
effective!as!normal!saline!in!reducing!wound!infection!rates.!The!transferability,!
feasibility,!and!costLbenefit!should!be!prudently!considered!before!adopting!this!
new!innovation! in!clinical!settings.!This!chapter!will! focus!on!how!to!apply! the!
latest! evidence! to! develop! an! evidenceLbased! protocol! for! using! tap!water! for!
wound!irrigation!in!HK!AEDs.!
Target-setting/audience-
-- The!target!setting!is!a!large!size!AED!in!Hospital!Authority.!It!is!one!of!the!
five!trauma!centers!in!Hong!Kong!that!consists!of!resuscitation!room,!acute!care!
room! and! minor! operating! theater! to! carry! out! wound! care! procedures.! It!
provides! 24! hours! emergency! service! and! the! attendance! rate! is! around! 500!
every!day.!The!target!audiences!are!patients!who!attend!AEDs!with!simple!acute!
traumatic!lacerations!and!the!majority!is!Chinese.!!
Transferability-of-the-finding!!
Before!adopting!the!proposed! innovation,! it! is!necessary!to!consider!the!
philosophy!of!care,!whether!the!proposed!innovation!fit!the!target!setting.!!
The! aim! of! the! AED! in! local! setting! is! to! provide! efficient! emergency!
services! with! costLeffective! manner! by! implementing! evidenceLbased! practice.!
Previously,!there!were!several!evidenceLbased!protocols!successfully!carried!out!
in!the!local!setting.!Patients!were!satisfactory!with!nursing!practice!according!to!
the!evidenceLbased!protocol.!Patients!are!willing!to!accept!changes!with!robust!
! 21!
evidence!support.!The!target!setting!in!local!AEDs!employed!similar!mission!and!
vision!with!selected!studies.!!
Hong! Kong! shares! similar! medical! development! and! background! with!
western! countries! of! selected! studies! (Weiss! et! al.,! 2013;!Moscati! et! al.,! 2007;!
Valente! et! al.,! 2003;! Bansal! et! al.,! 2002;! Dulecki! et! al,! 2005;! Fernandez! et! al.,!
2008).! The! AED! is! equipped! with! a! resuscitation! room,! acute! care! room! to!
handle! emergencies! and! disasters! such! as! traffic! accidents,! hazmat! incidents,!
influenza! outbreak,! which! is! similar! to! western! countries.! The! proposed!
innovation! will! benefit! a! significant! number! of! patients! and! generate! annual!
savings!for!hospitals!similar!to!selected!studies!since!there!are!about!8!wounds!
requiring!suture!every!day!in!local!AEDs.!!
With! reference!of! the! selected! studies! (Weiss! et! al.,! 2013;!Valente! et! al.!
2003),!the!proposed!innovation!will!take!about!18!months!to!implement.!It!takes!
1! month! for! preparation! and! communication,! 5! months! for! the! pilot! study,! 1!
month!for!progress!evaluation,!5!months!for!full! implementation!and!6!months!
for! outcome! evaluation! and! data! analysis.! The! details! will! be! attached! in!
Appendix!J.!!
3.2-Feasibility-
Apart!from!transferability,!feasibility!also!needs!to!be!assessed.!It!includes!
the! nursing! autonomy,! availability! of! staff! and! resources,! organization! climate,!
and!anticipated!resistance.!!
Nursing-autonomy-
Nurses! play! an! important! role! in! wound! management! in! HKAEDs.!
Wounds!were!mainly!closed!by!physicians!in!the!selected!studies!while!wounds!
were! closed!by!emergency!nurses! in!Hong!Kong.!Emergency!nurses! received!a!
! 22!
course! from! the! Accident! and! Emergency! Training! Center! (AETC)! for! wound!
management! training! in!Hong!Kong.! It! is! necessary! for! an! emergency!nurse! to!
pass! the!course!provided!by!AETC! in!order! to!provide!wound!management! for!
patients.!This!credential!process!ensures!emergency!nurses!possess!knowledge!
of!wound!management.!Thus,!emergency!nurses!have!the!autonomy!in!choosing!
materials!in!wound!management!based!on!evidence!and!terminate!the!proposed!
innovation!if!the!outcome!is!undesirable.!
Availability-of-staff-and-administrative-support-
!! One!factor!affect!the!feasibility!of!the!proposed!innovation!is!manpower.!
However,! resuscitation!occurs!any! time! in!AEDs!and! is! considered!as! the!most!
important! care! in! AEDs.! When! multiple! resuscitations! occur! in! the! AEDs,! the!
waiting! time! will! be! prolonged! and! minor! procedures! such! as! wound!
management! will! be! delayed! since! nurses! are! prioritized to! manage! lifeL
threatening!case.!When!a!patient!attends!AEDs!for!more!than!8!hours,!the!wound!
cannot!be!sutured!owing!to!higher!infection!rates.!Although!wound!dressing!will!
be!provided!for!the!patient,!the!patient!will!have!a!higher!chance!of!infection!due!
to! prolong! waiting! time.! The! infection! rate! is! the! outcome! of! the! proposed!
innovation!and!waiting! time! is! a! significant! factor! that!will! affect! the!outcome.!
The! longer! the!waiting! time,! the!higher! the! infection!rates.! In!addition,! it! takes!
time!for!data!collection!and!evaluation!when!implementing!proposed!innovation.!
Adequate!manpower!is!needed!to!compensate!for!the!time!used!for!unexpected!
resuscitation! and! data! collection.! It! can! be! achieved! by! duty! arrangement! and!
use!of!Special!Honorarium!Scheme!(SHS).!According! to!Hospital!Authority,!SHS!
provides! leave! encashment! for! nursing! or! medical! staff! who! provide! extra!
! 23!
service!in!AEDs.!So,!when!implementing!the!proposed!innovation,!support!from!
administration!is!needed.!!
Department! of! manager! (DOM),! Chief! of! Service! (COS),! Ward! Manager
�WM)!and!Health!Care!Assistant!(HCA)!will!also!involve!in!proposed!innovation.!
Medical!officer!(MO)!will!be!responsible!for!wound!assessment!when!a!patient!is!
present! to! AEDs! and! followLup,! and! provide! assistance! and! training! to! other!
health! care! professionals! if! necessary.! There! are! 8! Advanced! Practice! Nurses!
(APN),!32!Registered!nurses! (RN)!and!2!Enrolled!nurses! (EN)! received!wound!
care!training!from!AETC.!They!are!capable!of!providing!wound!care!in!AEDs!and!
are!available! for! the!proposed! innovation.! It! is!necessary! to! seek!approval!and!
consensus!from!the!administration!for!duty!arrangement!to!implement!proposed!
innovation.!A!communication!plan!with!the!administration!is!needed!and!will!be!
further!discussed!in!next!chapter.!
Availability-of-resources--
The!materials!used!are!also!similar!to!those!in!selected!studies!(Weiss!et!
al.!2013;!Valente!et!al,!2003).!The!suggested!syringe!used!in!the!selected!studies!
is! a! 35ml! syringe!with! the! splash! shield.! However,! the! 35ml! syringe!with! the!
splash! shield! is! not! available! in! local! AEDs.! A! 50! ml! syringe! with! 18! gauge!
angiocatheter!will!be!used!to!provide!the!suggested!pressure!of!more!than!8!psi!
for!irrigation!(Weiss!et!al.!2013).!A!50!ml!syringe!with!18!gauge!angiocatheter!is!
available! in! local! AEDs.! The! other! equipment! such! as! dressing! set,! suture!
materials! are! available! in! the! minor! operating! theater.! AntiLtetanus! injection!
(ATT)!will! be! provided! in! local! AEDs!when! patients! are! present! to! AEDs!with!
simple!acute!traumatic!lacerations.!But!whether!anti!tetanus!injection!was!given!
was!not!mentioned!in!the!selected!studies.!!
! 24!
Tap!water,!as!the!main!intervention!of!evidenceLbased!practice,!is!another!
important! resource! consideration.!According! to! the!Hong!Kong!Water!Supplies!
Department! (HKWSD),! tap! water! is! safe! to! consume! if! the! water! pipe! is! well!
maintained!in!the!buildings.!Quality!Water!Recognition!Scheme!for!Buildings!is!a!
scheme!provided!by!Hong!Kong!Water!Supplies!Department!to!ensure!the!water!
quality! complied! with! the! guidelines! of! World! Health! Organization! (WHO).! A!
certificate!will!be!issued!by!HKWSD!if!the!plumbing!systems!of!buildings!are!well!
maintained.!This!monitoring!system!ensures!tap!water!quality!complied!with!the!
standard! of! WHO.! Apart! from! attestation,! HKWSD! will! be! responsible! for!
checking!the!quality!of!tap!water!and!maintenance!of!plumbing!systems!for!AEDs!
under!Hospital!Authority.!The!target!settings!are!under!this!scheme!so!tap!water!
is!readily!available.!
Anticipated-resistance--
The! proposed! new! innovation! might! pose! potentially! increased! the!
workload!of!nursing!staff,!medical!officer,!and!health!care!assistant.!It!takes!extra!
time! to!get! familiarize!with! the!new!protocol!and! to!prepare! the!materials!and!
equipment!need!for!wound!irrigation!and!suturing!although!it!will!be!a!minimal!
change.! In! addition,! potential! challenges! by! patients! and! other! health! care!
professionals! will! be! anticipated! since! they! will! have! the! concern! about! the!
quality!of! tap!water!and! the! infection!rates.! It! is!common!before! implementing!
any! changes! from! current! practice.! Patients! will! have! questions! and! want! to!
obtain!more! information! about! proposed! innovation.! Effective! communication!
skill! is! essential! to! disseminate! information! of! proposed! innovation.! Staff!
training!and!education!is!important!for!developing!effective!communication!skill.!
In!addition,!the!pilot!study!is!necessary!and!it!involves!the!preliminary!test!of!an!
! 25!
innovation! to! estimate! the! materials! and! manpower,! thereby! reducing! the!
resistance! of! the! new! innovation.! The!details! of! the! pilot! study!will! be! further!
discussed!in!next!chapter.!!
3.3-Cost)benefit-Ratio-of-the-innovation-
Based! on! the! findings! from! the! selected! studies! (Weiss! et! al.,! 2013;!
Moscati!et!al.,!2007;!Valente!et!al.,!2003;!Bansal!et!al.,!2002;!Dulecki!et!al,!2005;!
Fernandez!et!al.,!2008),!it!is!estimated!that!the!new!innovation!will!benefit!both!
patients! and! local! AEDs! when! nursing! professionals! are! willing! to! provide!
compassionate!care!with!evidence!support.!!
Normal! saline!was! used! for! irrigation! in! current! practice,! using! normal!
saline! still! have! a! risk! of! having! an! infection.! Most! importantly,! it! is! much!
cheaper!than!using!normal!saline!if!a!large!amount!was!used!for!irrigation.!It!is!
estimated!that!$85440!will!be!saved!every!year!when!tap!water!is!used!instead!
of!normal!saline.!There!are!17!AEDs!in!Hospital!Authority,!it!is!estimated!that!the!
annual!savings!will!be!$1452480!for!17!AEDs!per!year!if!implementing!proposed!
innovation.!Normal!saline!need!to!be!discarded!within!24!hours!once!open,!and!
the!storage!place!cannot!take!into!accounts!by!costs.!!!
Comparison-of-materials-between-using-normal-saline-and-tap-water-
! Normal!saline! Tap!water!Cost!for!materials! 1000ml!Normal!saline!!
$30!per!bottle!Free! and! available!in!hospital!
Annual!savings! Normal! saline! per! bottle! X! number! of!wounds!per!day!X!356!=$30X8X356!=$85440!
The! other! materials! such! as! a! 50! ml! syringe,! 18! gauge! angiocathter,!
dressing!set!will!be!same!in!both!groups.!!
! 26!
Changing! current! practice! require! substantial! periods! of! training! for!
nurses.! A! brief! training!workshop!will! be! given! to! nurses! to! illustrate! how! to!
implement! the! innovation.! This! section! will! also! involve! HCA! since! they! are!
responsible! for! materials! and! equipment! preparation! in! the! minor! operating!
theater.! Ten! nurses! and! five! HCA! will! attend! the! workshop! and! share! the!
information! to! other! colleagues.! The! proposed! innovation! will! invite! Medical!
Officer! (MO)! to! share! the! knowledge! of! wound! care.! According! to! Hospital!
Authority! (HA),! the!median! salary! for!RN! is! about! $160!per!hour.! The!median!
salary!for!HCA!is!$60!and!the!median!salary!for!MO!is!$350!per!hour.!The!nonL
material!cost!will!include!training!hours!of!nurses!and!HCA.!!
Estimated-Cost-for-training-workshop-of-using-tap-water-for-irrigation-
Cost! for! Medical! Officer! 1Lhour!session!
�350-
Cost!for!RN!for!1Lhour!session!Cost!for!EN!for!1Lhour!session-
$160!X10=!$1600!$110X2=$220!
Cost! for! HCA! for! 1Lhour!session!
$60X5=$300!
Materials!for!demonstration!Expired! Normal! saline,!angiocatheter,!50!ml!syringe!
Available!in!AED!training!set!Free!
Total! $2470!From! the! above! calculations,! the! benefits! of! the! proposed! innovation!
outweigh!the!costs.!The!annual!savings!generated!from!this!proposed!innovation!
can! be! allotted! for! nurse! recruitment! or! study! subsidies! and! sponsorship! for!
further!development.!The!proposed!innovation!can!generate!more!savings!in!the!
long! run.! As! mention! previously,! resuscitation! can! occur! at! any! time! and!
adequate!manpower!is!needed.!It!can!be!achieved!by!duty!arrangement!and!the!
introduction! of! SHS.! It! estimated! that! the! budget! spend! on! the! proposed!
innovation! with! SHS! should! be! less! than! $70000! so! as! to! strive! a! balance!
between! cost! and! benefit.! The! estimated! amount! for! SHS! was! based! on! the!
! 27!
previous! protocol! developed.! The! actual! costs! depend! on! the! attendance! rate,!
waiting!time!and!conditions!of!patients!in!the!AEDs.!!!
Staff! moral! is! associated! with! a! desirable! working! environment.! A!
desirable! working! environment! includes! working! well! with! patients! and!
colleagues.!Clinical!experience!and!skills,!research!ability!are!essential!elements!
for!nurses.!When!nurses!are!competent!to!provide!evidenceLbased!care,!patients!
will!satisfy!with!nurses!and!increase!acceptance!of!the!role!of!nurses!in!AEDs.!It!
can! be! achieved! through! the! process! of! implementing! proposed! innovation.!
Promoting!evidenceLbased!care!not!only!poses!benefits!to!nurses!but!also!to!the!
department!as!it!associates!with!the!image!of!the!department!and!turnover!rate.!
The! department! will! develop! a! positive! image! by! research! utilization! and!
evidenceLbased! practice.! The! turnover! rate! will! decrease! by! the! lure! of! a!
comfortable!working!environment.!Local!AEDs!and!the!health!care!systems!will!
benefit!from!the!proposed!new!innovation!if!successfully!carried!out.!!
!
3.4-Evidence)based-practice-guideline-
Introduction-
This!guideline!is!developed!based!on!latest!systematic!reviews!and!trials.!
The!evidence!suggested!that!using!tap!water!is!as!effective!as!normal!saline!for!
wound! irrigation.!The! recommendations!were! synthesized!by!SIGN!50!and!are!
attached!in!Appendix!K!&!L.!The!transferability,!feasibility!and!costLbenefits!ratio!
from!the!above!suggested!that!it!is!worth!implementing!the!proposed!innovation!
in!the!clinical!setting.!
Summary-of-the-recommendations-
! 28!
The! purpose! of! the! guideline! is! to! equip! emergency! nurses! to! provide!
evidenceLbased!care!to!patients!attend!AEDs!with!acute!traumatic!lacerations.!!
According!to!SIGN!50,!the!levels!of!evidence!are!classified!into!level!1!to!
level!4!by!assessing!the!methodology!design!of!the!studies.!Level!1!is!articulated!
to!robust!evidence!such!as!RCT!whereas!level!4!is!articulated!to!weak!evidence!
such!as!an!expert!opinion.!With!higher!levels!of!evidence!(level!1),!it!implied!that!
the!risk!of!bias!is!the!lowest!and!lower!levels!of!evidence!(level!4),!the!risk!of!bias!
is!the!highest.!
For!the!grading!system!of! the!recommendations,! it!ranged!from!grade!A!
to!D!by!assessing! the!bodies!of!evidence!of! the!selected!studies.!Grade!A! is! the!
recommendation!with!higher!evidence!whereas!grade!D!is!the!recommendation!
with!lower!evidence!from!the!studies!and!reviews.!The!grading!system!helps!to!
differentiate!recommendations!from!which!levels!of!evidence.!!
The!details!of!the!recommendations!are!attached!in!the!Appendix!M!and!
the!details!of!grading!system!are!attached!in!Appendix!N.!The!recommendations!
are! graded! between! A! and! B! in! this! protocol,! it! implies! that! the!
recommendations! are! based! on! robust! evidence! from! the! studies.! Robust!
evidence!from!the!studies!is!essential!for!nurses!to!provide!care.!!
-
-
-
-
-
-
-
! 29!
Chapter-4-
Implementation-Plan-
4.1-Communication-plan-
- In! order! to! successfully! implement! the! proposed! innovation! to! AEDs,!
careful! planning! and! communication! with! the! administration! is! essential.! The!
first! step! is! to! identify! the! stakeholders! and! gain! support! for! the! proposed!
innovation.!
Identification-of-stakeholders---
Stakeholders!refer!to!an!individual!or!groups!that!will!be!affected!by!the!
result! of! the! innovation.! The! stakeholders! in! this! proposed! innovation! involve!
Chief! of! Service! (COS),! Medical! officers! (MO),! Department! Of!Manager! (DOM),!
Ward! Manager! (WM),! Advanced! Practice! Nurse! (APN),! Registered! nurses! RN,!
Enrolled!nurses!(EN),!Healthcare!assistance!(HCA)!and!patients!who!are!present!
to! AEDs! with! simple! traumatic! lacerations.! COS,! DOM! and! WM! are! top!
administration! and! they! have! mission! and! vision! to! promote! evidenceLbased!
guidelines.! In!order! to!adopt!proposed! innovation! in! local!AEDs,!obtain!mutual!
agreement!and!support!from!identified!stakeholders!are!necessary.!!
Communication-strategies-
Chief! of! Services! (COS),! Department! Operations! Manager! (DOM),! and!
Ward! Manager! (WN)! are! first! approach! since! they! play! an! important! role! in!
promoting! evidenceLbased! guidelines! in! local! AEDs! and! enhancing! positive!
attitudes! of! proposed! innovation.! In! addition,! they! are! at! the! top!management!
level! and! responsible! for! manpower,! finance! management,! and! resource!
allocation.!It!is!necessary!to!arrange!a!meeting!to!disseminate!information!about!
! 30!
the! significance,! feasibility,! transferability,! cost! and! benefits! ratio! of! the!
proposed! innovation.! The! major! concern! of! proposed! innovation! is! tap! water!
quality.! It! is! essential! to! include! the! risks!and!strategies!of!using! tap!water! for!
irrigation! in! the!meeting.! Furthermore,! it! is! necessary! to! liaise! and! coordinate!
with! Hospital! Engineering! Department! and! Hong! Kong! Water! Supplies!
Department! (HKWSD)! for! maintenance! of! water! plumbing! system,! routinely!
check!up!of!tap!water!quality.!It!can!be!achieved!by!writing,!sending!eLmail,!fax!
or!phone!to!the!corresponding!offices!for!accessing!information!and!application!
of!changing!plumbing!systems.!Water!samples!were!taken!for!microbial!analysis!
by!HKWSD!laboratories!in!order!to!comply!with!the!standard!with!WHO.!Before!
setting!up!the!liaison!between!local!AEDs!and!HKWSD,!communication!with!the!
top!administration!is!of!utmost!importance!for!adopting!proposed!innovation.!!
Apart!from!the!quality!of!tap!water,!manpower!and!finance!management!
are! other! significant! issues! of! proposed! innovation.! The! proposed! innovation!
involves! extra! manpower,! duty! arrangement! and! the! introduction! of! Special!
Honorary! Scheme! (SHS).! Since!manpower,! finance,! and! resource!management!
are! crucial! factors! that! affect! the! feasibility! of! the! innovation,! it! further!
emphasizes!the!necessity!of!communication!with!top!administration.!!
!When! proposed! innovation! endorsed! by! the! top! administration,! the!
second! approach! is! to! gain! support! from! APN,! NS! and! MO! as! they! are!
experienced!and!knowledgeable!in!wound!management.!Another!meeting!will!be!
arranged!with!APN,!NS!and!MO!to!invite!them!for!the!participation!of!proposed!
innovation.! With! support! from! APN! and! NS,! they! can! provide! assistance,!
opinions!about!proposed!innovation!and!act!as!nurse!coordinators!of!proposed!
innovation.! Regarding! the! quality! of! emergency! nurses,! to! ensure! emergency!
! 31!
nurses! are! capable! of! providing! wound! management! to! patients,! emergency!
nurses! need! to! have! wound! management! workshops! of! using! tap! water! for!
irrigation.! APN,! NS,! and! MO! are! responsible! for! the! workshop,! outcome!
evaluation! and! provide! wound! assessment! when! patient! followLup.! Then!
information! about! proposed! innovation!will! be! presented! to! registered! nurses!
and!enrolled!nurses!in!the!meeting!as!they!are!users!of!the!protocols!and!most!
importantly,! they! provide! wound! management! to! patients.! Since! HCA! will!
prepare!wound!management!materials,!it!is!necessary!to!provide!information!of!
proposed!innovation!to!them.!!
4.2-Pilot-study-plan!
With!reference!of!selected!studies!(Weiss!et!al.,!2013;!Moscati!et!al.,!2007;!
Valente! et! al.,! 2003),! the! proposed! innovation! takes! 5L18! month! for! subject!
enrollment!and!data!analysis.!Since!there!are!no!local!studies!using!tap!water!for!
wound!management,!it!is!suggested!that!the!pilot!study!will!last!for!5!months!for!
feasibility!test!and!conducted!by!nurse!coordinators.!The!aim!of!the!pilot!study!is!
to! gather! information! regarding! manpower,! resource,! and! finance! so! that! the!
proposed! innovation! can! be! refined! before! full! implementation.! In! addition,!
resources! such!as!wound! care! leaflets!will! be!prepared.!The! content!of!wound!
care! leaflets! will! include! information! about! signs! and! symptoms! of! wound!
infection.!The!details!of!wound!care!leaflets!will!be!attached!in!Appendix!O.!!!
Subject-recruitment-
The! subject! recruitment!will! be! patients!who! are! present! to! AEDs!with!
simple!acute!traumatic!lacerations!by!using!convenient!sampling!since!there!are!
no! local! studies! using! tap! water! for! wound! management.! The! inclusion! and!
! 32!
exclusion!criteria!will!be!the!same!as!the!proposed!innovation!so!as!to!assess!the!
feasibility!and!be!consistent!with!the!proposed!innovation.!!
Nature-and-numbers-of-clients-
The! wound! characteristics! such! as! wound! length,! width,! depth! and!
location! will! be! collected.! Based! on! the! statistics! of! local! AEDs,! there! are!
approximately!8!wounds!requiring!suture!every!day.!With!reference!of!selected!
studies,!the!attrition!rate!is!about!10%!(Moscati!et!al.,!2007;!Valente!et!al).!Using!
online!calculation!(Lenth,!2009),!assume!the!baseline! infection!rate!of!5%,! it! is!
estimated!that!the!sample!size!will!be!139!with!95%!confidence!interval.!!
Calculations!of!sample!size!(n)!for!pilot!study!Max!tolerable!error=5%!Anticipated!proportion!=!10%!Using!online!calculation!(Lenth,!2009)!N=139!!
Ethical-consideration-
-- It! is! crucial! to! obtain! approval! from! Hospital! Authority! to! carry! out!
proposed! innovation.! Informed! consent!will! be! obtained! prior! to! intervention,!
enable! patients! obtain! adequate! information! regarding! intervention.! Patients!
will! receive!wound!management! according! to! the! guideline! as! attached! in! the!
previous!chapter!and!will!be!instructed!to!follow!up!on!day!2!and!extra!follow!up!
will! be! provided! according! to!wound! characteristics! of! patients.! The! details! of!
pilot!study!as!follow:!
-
-
-
-
! 33!
Flow-of-pilot-study--
!
4.3-Evaluation-plan--
Evaluation!is!a!process!of!the!judgment!of!the!worthiness!of!the!proposed!
innovation.! An! evaluation! plan! is! crucial! to! determine! the! success! of! the!
innovation.! It! consists!of!patient!outcomes,!health! care!provider!outcomes!and!
system!outcomes.!
Outcome-evaluation!-
With!reference!of! the!selected!studies!(Weiss!et!al.,!2013;!Moscati!et!al.,!
2007;!Valente!et!al.,!2003;!Bansal!et!al.,!2002;!Dulecki!et!al,!2005;!Fernandez!et!
al.,!2008),!the!infection!rate!will!be!primary!patient!outcome!of!innovation!and!it!
is! significant! to! test! the! effectiveness! of! the! proposed! innovation.! Patients! are!
invited! to! come! back! AEDs! at! day! 2! for! wound! assessment.! The! signs! and!
symptoms! of! infection! include! redness,! increased! pain,! increased! wound! size,!
swelling!and!fever.!Wound!evaluation!will!be!done!by!wound!care!team!with!one!
nurse!and!one!medical!officer!during!followLup!(Weiss!et!al.,!2013;!Moscati!et!al.,!
Follow!up!!
Analysis!
Enrollment!Assess!for!eligibility!!(n!>139)!
Follow!up!at!!day!2!
Infection!rate!!!Patient!satisfaction!score!
Lost!to!follow!up!
Phone!contact!
Intervention!
! 34!
2007;!Valente!et! al.,! 2003;!Bansal! et! al.,! 2002).!They!are! required! to! fill! in!one!
assessment!as!attached!in!Appendix!P!for!a!record.!!
The! wound! culture! will! only! be! taken! if! wound! considered! as! infected!
when!followLup!at!Day!2!(Bansal!et!al.,!2002).! !Wounds!will!be!infected!if!more!
than!105!bacteria!per!gram!were! found! in! tissue! (Moscati! et! al.,! 2007).!Normal!
wound!heal!within!2!to!30!days!for!simple!acute!traumatic!lacerations.!Delayed!
wound! healing! more! than! 30! days! and! early! removal! of! stitches! regarded! as!
infection!(Moscati!et!al.,!2007).!!
Since! interpersonal!wound!management! techniques!will!be!a! factor! that!
affects! infection! rates,! it! is!necessary! to! form!a!wound!management! team!with!
nurses! and! medical! officers! to! monitor! wound! management! technique.! In!
addition,!extraneous!variables!such!as!patient!‘s!education!level!and!selfLhygiene!
might!affect!patient!‘s!health!condition.!So,!it!is!necessary!to!provide!wound!care!
leaflet!and!education!before!discharge.!If!a!patient!does!not!return!for!followLup!
on!day!2,!nurse!coordinators!will!contact!the!patient!by!phone.!Patients!who!fail!
to!contact!will!regard!as!lost!to!followLup!(Weiss!et!al.!2013).!!!
Health! care! provider! outcomes! include! staff! satisfaction! level.! A!
questionnaire! will! be! given! to! staff! after! innovation! in! order! to! assess! the!
acceptability!of!the!proposed!innovation.!Health!care!providers!need!to!fill!in!the!
questionnaire.!The!questionnaire!will!be!attached!in!Appendix!Q.!After!receiving!
the!questionnaire! from!staff,!a!meeting!will!be!arranged!for!staff! to!resolve!the!
concern!of!the!proposed!innovation.!The!meeting!will!focus!on!the!quality!of!tap!
water!in!Hong!Kong.!The!content!include!the!latest!studies!of!using!tap!water!for!
irrigation,!advantages!of!using!tap!water!for!wound!irrigation,!comparison!with!
normal!saline,!thereby!reducing!the!resistance!of!proposed!innovation.!!
! 35!
System!outcomes! include!average!waiting! time! in!AEDs!and!costs!of! the!
innovation.! The!waiting! time! in!AEDs! and! costs! spent! on! proposed! innovation!
will! be! counted!and!monitored.!The!average!waiting! time! can!be! calculated!by!
using! the! Accident! and! Emergency! Information! System! (AEIS)! in! local! AEDs!
(Chan.! 2000).! The!waiting! time!of! using! tap!water! for! irrigation! should!be! the!
same! as! using! normal! saline.! Prolong! waiting! time! will! affect! infection! rate,!
which!is!the!patient!outcome!of!proposed!innovation.!
!AEIS! is! the! computer! system! with! intraLnetwork! that! link! all!
workstations!in!the!hospitals!in!Hong!Kong.!Patient!‘s!clinical!data,!for!instance,!
allergy!history,!diagnoses,!drug!treatment,!medical!history,!immunization!record,!
AED!attendance! record,! triage! category,! laboratory! and! radiology! investigation!
and! result! can! be! viewed! and! retrieved! efficiently.! In! addition,! with! the!
development!of!bar!code!technology,!the!triage,!waiting!and!discharge!time!will!
be!recorded! in!AEIS.!The! introduction!of!AEIS! facilitates!not!only!AEDs!service!
but!also!clinical!research.!Most!importantly,!AEIS!was!used!since!1991!and!now!
available!in!all!HKAEDs.!!The!materials!used!for!wound!management!can!also!be!
anticipated!since!clinical!data!of!patients!will!be!recorded!in!AEIS.!!
Using! tap! water! for! wound! irrigation! will! generate! annual! savings! for!
AEDs!when!compared!with!using!normal!saline!(Weiss!et!al.,!2013;!Moscati!et!al.,!
2007;!Valente!et!al.,!2003;!Bansal!et!al.,!2002).!So! the!cost!and!waiting! time! in!
AEDs! need! to! be! counted! for! system! outcome.! In! addition,! severe! wound!
infection!might! lead!to! the!use!of!antibiotics!or!even!admission.!The!admission!
rate! and! use! of! antibiotics! relate! to! propose! innovation! will! be! monitored! by!
AEIS! as! well.! Space! for! storage! of! normal! saline! cannot! be! quantified! and!
analyzed!after!implementation!of!proposed!innovation.!!!!
! 36!
Data-analysis--
The!difference!in!the!infection!rate!will!be!evaluated!by!using!one!sample!
tLtest!with!95%!confidence!level!to!determine!statistical!significance!before!and!
after!implementing!proposed!innovation.!!
Wound! characteristics! are! quantitative! variables! such! as! length,! width!
and!depth!are!measured!by!mean!and!standard!deviations.!The!cost!and!average!
waiting! time! in! AEDs! will! be! described! and! analyzed! by! means! and! standard!
deviations.!Intention!to!treat!will!be!used!when!the!patient!lost!to!follow!up.!!
Regarding!patient!satisfaction!level,!patients!need!give!a!satisfaction!score!
ranged! from!1! to!5! in!AEDs.!The!questionnaire! is! attached! in!Appendix!R.!The!
score!will!be!analyzed!by!the!mean.!!!
Effectiveness-of-the-guideline-
With!reference!of!selected!studies!(Weiss!et!al.,!2013;!Moscati!et!al.,!2007;!
Valente! et! al.,! 2003;! Bansal! et! al.,! 2002;! Dulecki! et! al,! 2005;! Fernandez! et! al.,!
2008),!the!infection!rate!is!around!5!%!for!normal!saline!and!tap!water!irrigation.!!
The!protocols!will!be!regarded!as!effective!when!the!infection!rate!of!using!tap!
water!for!wound!irrigation!is!lower!than!or!the!same!as!using!normal!saline.!The!
waiting!time!should!be!less!than!8!hours!when!patients!attend!AEDs!with!simple!
acute! traumatic! lacerations.!Apart! from!waiting! time,! the! guidelineL! regards! as!
effective!when! the! cost! of! using! tap!water! outweighs! the! cost! of! using! normal!
saline.! It! is!expected!that!the!annual!savings!will!be!$85400!each!year! in!AEDs.!
There! is! no! existence! of! local! studies! for! reference,! the! target! of! the! proposed!
innovation! is! to! generate! 50%! of! savings,! and! the! pilot! study! is! necessary! for!
further! verification.!With! regard! to!patient! satisfaction! level,!mean! score!more!
! 37!
than! 2! will! be! considered! as! satisfactory! based! on! previous! evidenceLbased!
protocols.!!!
- The! success! of! implementing! proposed! innovation! includes! careful!
planning!and!preparation.!The!key! components! consist!of! communication!with!
top! administration! and! support! from! various! stakeholders.! The! pilot! study!
should!be!done!to!test!the!feasibility!before!full!implementation!of!the!proposed!
innovation.! The! proposed! innovation! can! be! successfully! implemented! with!
communication!plan,!pilot!study,!and!evaluation.!
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
! 38!
References-
1. Chan! JTS.!What!will!be! the!percentage!drop! in!attendance!of!Accident!&!
Emergency! department! after! implementation! of! charges?! Hong! Kong!
Journal!of!emergency!medicine!2001;8:241L246!
2. Lauren!MW,!Hao!Y,!Pamela!LO,!Raynard!W.!Overview!of! children! in! the!
emergency! Department,! 2010.! Available! from:" http://hcup)
us.ahrq.gov/reports/statbriefs/sb157.jsp!!
3. Berwald! N,! Khan! F,! Zehtabchi! S.! Antibiotic! prophylaxis! for! ED! patients!
with! simple! hand!lacerations:! a! feasibility! randomized! controlled! trial.!
Am!J!Emerg!Med.!2014!Jul;32(7):768L71.!!
4. Weiss! EA,! Oldham! G,! Lin! M,! Foster! T,! Quinn! JV.! Water! is! a! safe! and!
effective!alternative! to! sterile!normal!saline!for!wound!irrigation!prior! to!
suturing:!a!prospective,!doubleLblind,!randomised,!controlled!clinical!trial.!
BMJ!Open.!2013!Jan!16;3(1).!
5. Moscati!RM,!Mayrose!J,!Reardon!RF,!et!al.!A!multicenter!comparison!of!tap!
water! versus! sterile! saline! for! wound! irrigation.!Acad! Emerg!
Med!2007:14:404–10!
6. Valente!JH,!Forti!RJ,!Freundlich!LF,!ZandiehSo,!Crain!EF.!Wound!irrigation!
in!children:!saline!solution!or!tap!water.!Ann!Emerg!Med!2003:41:609L16.!
7. Bansal!BC,!Wiebe!RA,!Perkins!SD,!Abramo!TJ.-Tap!water!for!irrigation!of!
lacerations.!Am!J!Emerg!Med.!2002!Sep:20(5):469L72.-
8. Quinn!JV,!Polevoi!SK,!Kohn!MA.!Traumatic!lacerations:!what!are!the!risks!
for! infection!and!has!the! `golden!period'!of! laceration!care!disappeared?-
Emerg!Med!J.!2014!Feb;31(2):96L100.!-
! 39!
9. Zehtabchi!S,!Tan!A,!Yadav!K,!Badawy!A,!Lucchesi!M.!The!impact!of!wound!
age!on!the!infection!rate!of!simple!lacerations!repaired! in! the!emergency!
department.!Injury.!2012!Nov;43(11):1793L8.!Epub!2012!Mar!15.!Review.-
10. -Stetler,! C! (2001).! Updating! the! Stetler! Model! of! research! utilization! to!
facilitate! evidence! practice.! Nursing,! 49(6a0,! 272L278.- Available! from:!
http://www.ktdrr.org/ktlibrary/articles_pubs/ktmodels/figures1L
6.html#figure5ste-
11. -Dulecki!M,!Pieper!B.!Irrigating!simple!acute!traumatic!wounds:!A!review!
of!the!current!Literature.!J!Emerg!Nurs;31:156L60!
12. !Fernandez!R,!Griffiths!R.!Water!for!wound!cleansing.!Cochrane!Database!
Syst! Rev.! 2008! Jan! 23;(1):CD003861.! Review.! Update! in:! Cochrane!
Database!Syst!Rev.!2012;2:CD003861.!
13. SIGN!Available!from: http://www.sign.ac.uk/methodology/checklists.html-
14. Hospital! Authority! Statistical! Report! 2012L2013! Available! from:!
http://www.ha.org.hk/upload/publication_15/491.pdf-
15. Hong! Kong! Water! Supply! department.! Available! from:!
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2760706/pdf/12245_20
09_Article_98.pdf-
16. Scottish! Intercollegiate! Guidelines! Network.! (SIGN)! Available! from:!
http://www.sign.ac.uk/pdf/qrg50.pdf-
17. Special! Honorarium! Scheme! (SHS).! http://www.legco.gov.hk/yr12L
13/english/panels/hs/papers/hs0318cb2L758L9Le.pdf-
18. Lenth,! R.,! V,! (2009).! Sample! size! calculations!
http://www.cs.uiowa.edu/~rlenth/Power/!!
! 40!
19. Chan!JT.!(2000).!Computerisation!of!accidents!and!emergency!systems!in!
Hong!Kong.!HKMJ!2000;6:276L82!
20. Moher! D,! Liberati! A,! Tetzlaff! J,! Altman! DG,! The! PRISMA! Group! (2009).!
Preferred! Reporting! Items! for! Systematic! Reviews! and! MetaLAnalyses:!
The!PRISMA!Statement.!PLoS!Med!6(6):!e1000097.!
!
!
Appendix(A(
The(Stetler(Model(of(Research(Utilization!
Appendix(B(
Search'results'
Keywords) Searched)Databases)PudMed)<199482014>) Medline(OVIDSP)) CINAPHL) Cochrane)
1.)tap)water) 5490) 6719) 101) 7)
2.)laceration) 5949) 1862) 70) 18)
3.)traumatic)wound) 36375) 165) 9) 15)
4.)normal)saline) 18756) 13511) 273) 32)
5.)Irrigation) 30945) 26556) 469) 36)
1and)2) 10) 3) 0) 5)
1)and)4) 82) 44) 2) 1)
1)and)3) 10) 0) 0) 2)
3)and)4) 125) 0) 0) 9)
4)and)5) 672) 489) 29) 3)
1)and)4)and)5) 21) 11) 0) 1)
1)and)2)and)4)and)5) 6) 2) 0) 4)
1)and)3)and)4)and)5) 2) 0) 0) 0)
Appendix(C(
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097
For$more$information,$visit$www.prisma2statement.org.
PRISMA$2009$Flow$Diagram
Records(identified(through(database(searching(
(n(=((6()(
Screen
ing$
Includ
ed$
Eligibility$
Iden
tification$
Additional(records(identified(through(other(sources(
(n(=((2()(
Records(after(duplicates(removed((n(=(6()(
Records(screened((n(=(6((()(
Records(excluded((n(=((0()(
Full?text(articles(assessed(for(eligibility(
(n(=(4(()(
Full?text(articles(excluded,(with(reasons(
(n(=(0(()(
Studies(included(in(qualitative(synthesis(
(n(=((0()(
Studies(included(in(quantitative(synthesis(
(meta?analysis)((n(=((4()(
Table&of&evidence& Appendix(D&Questions:(In(patients(with(acute(traumatic(wounds,(is(tap(water(effective(as(normal(saline(irrigation(in(reducing(infection?(
Citation Study design Patient and
Characteristics
Intervention Comparison Length of
Follow-up
Outcome Measures Effect size
Weiss et
al, 2013
Prospective,
RCT, double
blind, single
center
>1 year old
Present to ED
less than 9 hours
Wounds were anesthetized.
A 35 ml syringe and 18-gauge catheter were used
to generate pressure (>8psi) for normal saline and
tap water irrigation.
Wound closed by physician using standard
technique.
Normal saline: 308 Tap water:
317
Structured
follow up
at 48 hr
and 30
days
Signs of infections
1) Stitch abscess
2) Erythema>1cm
3) Gross exudate
4) Fever>38°C
Infection
Normal saline: 20(6.4%)
Tap water: 11(3.5%)
Difference: 2.9%
Moscati
et al,
2007
Prospective,
multicenter,
Unblinded
convenient
sampling,
>17 year old
Present to ED
less than 8 hour
Wounds were anesthetized.
Wounds were irrigated with tap water from
plastic water tubing connect with water tap for at
least 2 minutes. For normal saline irrigation, a 35
ml syringe with splash shield was used. Wound
then closed by physician.
Normal saline: 334 Tap water:
300
Follow up
between
5-14 days
Signs of infection
1) Need early removal of
stitches
2) Drainage
3) Start antibiotics
Infection
Normal saline: 11(3.3%)
Tap water: 12(4%)
Difference: 0.7%
Valente
et al,
2003
Quasi
Randomized
controlled
trial
Age:>1and <17
year old
Wounds were anesthetized.
Wounds were irrigated with running tap water
from the faucet with standard pressure and flow
with minimum of 10 sec. For normal saline group,
a minimum of 100 ml normal saline with a 30-60
ml syringe with a 18-gauge angiocatheter
Normal saline: 271 Tap water:
259
Wound
check
between
48-72
hours
Signs of infection
1) Tenderness
2) Warmth
3) adenopathy
4) Fever
5) Lymphangitis
Infection Normal saline: 7(2.6%)
Tap water: 7(2.7%)
Difference: 0.1%
Bansal et
a, 2002
Prospective,
Pilot study
Single
blinding
Age:>1and <18
Hand
lacerations were
excluded.
500 ml solution of tap water or normal saline was
prepared in a basin. Wounds were irrigated by
using a 35 ml syringe to generate pressure
between 25-40 psi.
Normal saline:
24
Tap water: 21
Wound
check after
48hours
Signs of infection
1) Cellulitis or erythema
>4mm with tenderness
2) Purulent discharge
3) lymphangitis
4) Dehiscence>2mm
Wound culture positive
Infection
Normal saline:2
Tap water:2
Difference:1.2%
Wound culture result positive
Normal saline: 29%(positive in 7 of
24)
Tap water: 52% (positive in 11 of 21)
Difference: 23%
Appendix(E(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 1 of 3 Review date: None
S I G N
Methodology*Checklist*2:*Controlled*Trials*
Study identification (Include author, title, year of publication, journal title, pages) 1. Weiss( EA,( Oldham( G,( Lin( M,( Foster( T,( Quinn( JV.( Water( is( a( safe( and( effective( alternative( to(
sterile(normal(saline(for( wound(irrigation(prior( to( suturing:( a( prospective,( doubleGblind,(randomised,(controlled(clinical(trial.(BMJ(Open.(2013(Jan(16;3(1).(
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ! 2. Other reason ! (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i
Yes
1.2 The assignment of subjects to treatment groups is randomised.ii
Yes (By computer)
1.3 An adequate concealment method is used.iii
Yes (By coding that assign the solutions on the numbered bowl.The bowl was filled with solution by technician, then the label was removed, physician used the bowl of solutions for irrigation)
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes (Double blind)
1.5 The treatment and control groups are similar at the start of the trial.v
Yes (no difference in the demographic or clinical characteristics)
1.6 The only difference between groups is the treatment under investigation.vi
Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes (signs of infection)
Appendix(E(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 2 of 3 Review date: None
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
0.96%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Can’t say (no mention)
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Does not apply (single center)
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:xi
High quality (++) 8 of 10 criteria
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions. ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study. iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%. iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study. v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded.
Appendix(E(
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vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution. vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study. viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study. ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study. x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres. xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
Appendix(F(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 1 of 3 Review date: None
S I G N
Methodology*Checklist*2:*Controlled*Trials*
Study identification (Include author, title, year of publication, journal title, pages) 1. Moscati RM, Mayrose J, Reardon RF, et al. A multicenter comparison of tap water versus sterile saline for
wound irrigation. Acad Emerg Med 2007;14:404–10
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ! 2. Other reason ! (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i
Yes
1.2 The assignment of subjects to treatment groups is randomised.ii
Yes (By computer)
1.3 An adequate concealment method is used.iii
Yes (in a envelop)
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
No (patients know they are irrigated with tap water as wound were irrigated under the water tap)
1.5 The treatment and control groups are similar at the start of the trial.v
Yes (No difference between two groups)
1.6 The only difference between groups is the treatment under investigation.vi
Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes (Signs of infection)
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
10%
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Can’t say (No mention)
Appendix(F(
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1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Yes (two center)
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:xi
Acceptable (+) 7 of 10 criteria
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions. ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study. iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%. iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study. v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded. vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution. vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome
Appendix(F(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 3 of 3 Review date: None
measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study. viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study. ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study. x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres. xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
Appendix(G(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 1 of 3 Review date: None
S I G N
Methodology*Checklist*2:*Controlled*Trials*
Study identification (Include author, title, year of publication, journal title, pages) 1. Valente JH, Forti RJ, Freundlich LF, ZandiehSo, Crain EF. Wound irrigation in children: saline solution or tap
water. Ann Emerg Med 2003;41:609-16.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ! 2. Other reason ! (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i
Yes
1.2 The assignment of subjects to treatment groups is randomised.ii
Can’t say (patients were allocated to tap water or normal saline group based on the basis of the month)
1.3 An adequate concealment method is used.iii
No
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
No (Wounds were irrigated under the water tap)
1.5 The treatment and control groups are similar at the start of the trial.v
Yes
1.6 The only difference between groups is the treatment under investigation.vi
Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes (Signs of infection)
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
7.5%
Appendix(G(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 2 of 3 Review date: None
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Can’t say ( No mention)
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Does not apply (single center
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:xi
Acceptable (+) 5 of 10 criteria
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions. ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study. iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%. iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study. v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded. vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups
Appendix(G(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 3 of 3 Review date: None
were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution. vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study. viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study. ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study. x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres. xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
Appendix(H(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 1 of 3 Review date: None
S I G N
Methodology*Checklist*2:*Controlled*Trials*
Study identification (Include author, title, year of publication, journal title, pages) 1. Bansal BC, Wiebe RA, Perkins SD, Abramo TJ. Tap water for irrigation of lacerations. Am J Emerg Med. 2002
Sep;20(5):469-72.
Guideline topic: Key Question No: Reviewer:
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question ! 2. Other reason ! (please specify):
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i
Yes
1.2 The assignment of subjects to treatment groups is randomised.ii
Yes (Using a randomization schedule)
1.3 An adequate concealment method is used.iii
Yes (Non investigator prepare the bowl of solutions for irrigation)
1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.iv
Yes (single blindling)
1.5 The treatment and control groups are similar at the start of the trial.v
Yes
1.6 The only difference between groups is the treatment under investigation.vi
Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way.vii
Yes (Signs of infection and wound culture result)
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?viii
0%
Appendix(H(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 2 of 3 Review date: None
1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).ix
Can’t say (No mention)
1.10 Where the study is carried out at more than one site, results are comparable for all sites.x
Does not apply (Single center)
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise bias? Code as follows:xi
Acceptance (+) 7 of 10 criteria
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes
2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.
Comments: Hand lacerations were excluded, small sample size.
i Unless a clear and well defined question is specified, it will be difficult to assess how well the study has met its objectives or how relevant it is to the question you are trying to answer on the basis of its conclusions. ii Random allocation of patients to receive one or other of the treatments under investigation, or to receive either treatment or placebo, is fundamental to this type of study. iii Allocation concealment refers to the process used to ensure that researchers are unaware which group patients are being allocated to at the time they enter the study. Research has shown that where allocation concealment is inadequate, investigators can overestimate the effect of interventions by up to 40%. iv Blinding refers to the process whereby people are kept unaware of which treatment an individual patient has been receiving when they are assessing the outcome for that patient. It can be carried out up to three levels. Single blinding is where patients are unaware of which treatment they are receiving. In double blind studies neither the clinician nor the patient knows which treatment is being given. In very rare cases studies may be triple blinded, where neither patients, clinicians, nor those conducting the analysis are aware of which patients received which treatment. The higher the level of blinding, the lower the risk of bias in the study. v Patients selected for inclusion in a trial must be as similar as possible. The study should report any significant differences in the composition of the study groups in relation to gender mix, age, stage of disease (if appropriate), social background, ethnic origin, or co-morbid conditions. These factors may be covered by inclusion and exclusion criteria, rather than being reported directly. Failure to address this question, or the use of inappropriate groups, should lead to the study being downgraded. vi If some patients received additional treatment, even if of a minor nature or consisting of advice and counselling rather than a physical intervention, this treatment is a potential confounding factor that may invalidate the results. If groups
Appendix(H(
File name : Checklist 2 – Controlled Trials Version 2.0 28/05/2012 Produced by: Carolyn Sleith Page 3 of 3 Review date: None
were not treated equally, the study should be rejected unless no other evidence is available. If the study is used as evidence it should be treated with caution. vii The primary outcome measures used should be clearly stated in the study. If the outcome measures are not stated, or the study bases its main conclusions on secondary outcomes, the study should be rejected. Where outcome measures require any degree of subjectivity, some evidence should be provided that the measures used are reliable and have been validated prior to their use in the study. viii The number of patients that drop out of a study should give concern if the number is very high. Conventionally, a 20% drop out rate is regarded as acceptable, but this may vary. Some regard should be paid to why patients dropped out, as well as how many. It should be noted that the drop out rate may be expected to be higher in studies conducted over a long period of time. A higher drop out rate will normally lead to downgrading, rather than rejection of a study. ix In practice, it is rarely the case that all patients allocated to the intervention group receive the intervention throughout the trial, or that all those in the comparison group do not. Patients may refuse treatment, or contra-indications arise that lead them to be switched to the other group. If the comparability of groups through randomisation is to be maintained, however, patient outcomes must be analysed according to the group to which they were originally allocated irrespective of the treatment they actually received. (This is known as intention to treat analysis.) If it is clear that analysis was not on an intention to treat basis, the study may be rejected. If there is little other evidence available, the study may be included but should be evaluated as if it were a non-randomised cohort study. x In multi-site studies, confidence in the results should be increased if it can be shown that similar results were obtained at the different participating centres. xi Rate the overall methodological quality of the study, using the following as a guide: High quality (++): Majority of criteria met. Little or no risk of bias. Results unlikely to be changed by further research. Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias, Conclusions may change in the light of further studies. Low quality (0): Either most criteria not met, or significant flaws relating to key aspects of study design. Conclusions likely to change in the light of further studies.
I Appendix(I(
! Proposed(innovation(
Weiss(et(al.( Moscati(et(al.( Valente(et(al.( Bansal(et(al.(
Patients( ( Age(>1( Age>1( Age>17( Age(>1(<17( Age>1(<18(AEDs(presentation( (
Wound(<(8(hours( Wound(<(9(hours( Wounds(<8(hours( Wound<(8(hours! Wounds(<(8(hours(
Wound(size( Mean(3(cm( <3cm(3.1F6cm(>6(cm(
Around(0.5F15(cm(Mean(3cm(
No(mention(Claim(similar(in(both(groups(
<=3(cm(4F5cm(>6(cm(
Wound(site/(location(
Head(and(neck(Trunk(!
Head(and(neck(Trunk(Prox(extremity(Distal(extremity(
Head(and(neck(Trunk(Upper(extremity(Lower(extremity(Unknown!
FaceFscalp(Trunk–upper(extremity(Hand(Lower(extremity(Foot(!
Leg( (Hand( (Foot( (Arm!
Sample(size( Convenience(sampling( (
Normal(saline:(308(Tap(water:(317!
Normal(saline:(334(Tap(water:(300(
Normal(saline:(271(Tap(water:(259(
Normal(saline:(24(Tap(water:(21!
AEDs(setting( Local(ED( ED( ED( Paediatric(ED( ED(Estimated(cost(and(materials(of(using(tap(water(and(normal(saline(
Normal(saline(1L($30(per(bottle((Annual(savings( (30X8X356=85440((Dressing(set,(suture(materials(will(be(the(same(in( (
Normal(saline:(500(ml(Normal(saline($0.75((Charge(for(patients($10((Tap(water:(free(of(charge((Annual(savings( ($7.5(million(for(hospital($100(million(for(patients!
Normal(saline:($9.11(500(ml(SS$3.08(35ml(syringe($0.90(Splash(shield:($5.13((Tap(water($0.0015(per(patient(With(extension(tubing($0.22(per(patients((Normal(saline(irrigation:($72,880,000(Tap(water(irrigation:($7,280,000(Annual(savings:($65,600,000!
Normal(saline(1(L:($2.01(per(bottle((60(ml(syringe(Splash(shield((Cost(of(60(ml(syringe(and(splash(shield(did(not(mention(in(the(study(!
500(ml(Normal(Saline( (35ml(syringe( (Sterile(basins(Splash(shield(!Cost(of(the(materials(did(not(mention(in(the(study(
Appendix(J( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( (
Timeline for using tap water for irrigation in AEDs
Month& & 1& 2& 3& 4& 5& 6& 7& 8& 9& 10& 11& 12& 13& 14& 15& 16& 17& 18&
Communication&And&preparation& &
& & & & & & & & & & & & & & & & & &
Pilot&study& & & & & & & & & & & & & & & & & & &
Progress&evaluation&
& & & & & & & & & & & & & & & & & &
Full&implementation&
& & & & & & & & & & & & & & & & & &
Outcome&evaluation&
& & & & & & & & & & & & & & & & & &
Data&analysis& & & & & & & & & & & & & & & & & & &
Appendix(K(Quality(of(selected(studies((
(((((((
Studies( Design( Ratings(Weiss,(E.(A.,(Oldham,(G.,(Lin,(M.,(Foster,(T.,(&(Quinn,(J.(V.((2013).( Water( is( a( safe( and( effective( alternative( to(sterile( normal( saline( for( wound( irrigation( prior( to(suturing:( a( prospective,( doubleRblind,( randomised,(controlled(clinical(trial.(BMJ$Open,$3(1).(((
RCT,(double(blind(
1+(
Moscati,(R.(M.,(Mayrose,(J.,(Reardon,(R.(F.,(Janicke,(D.(M.,(&( Jehle,( D.( V.( (2007).( A(multicenter( comparison( of( tap(water( versus( sterile( saline( for( wound( irrigation.( Acad$Emerg$Med,$14(5),(404R409.((
Prospective,(multicenter,(Controlled(study(
2+(
Valente,(J.(H.,(Forti,(R.(J.,(Freundlich,(L.(F.,(Zandieh,(S.(O.,(&( Crain,( E.( F.( (2003).( Wound( irrigation( in( children:(saline( solution( or( tap( water?( Ann$ Emerg$ Med,$ 41(5),(609R616.(((
Quasi(RCT( 2R(
Bansal,(B.(C.,(Wiebe,(R.(A.,(Perkins,(S.(D.,(&(Abramo,(T.(J.((2002).( Tap( water( for( irrigation( of( lacerations.( Am$ J$Emerg$Med,$20(5),(469R472.(((
Prospective( 2+(
Dulecki( M,( Pieper( B.( Irrigating( simple( acute( traumatic(wounds:( A( review( of( the( current( Literature.( J( Emerg(Nurs;31:156R60((
Review( 3(
Fernandez,( R.,( &( Griffiths,( R.( (2012).(Water( for(wound(cleansing.(Cochrane$Database$Syst$Rev,$2,(Cd003861.(((
Systematic(review(
1++(
Appendix(L(
(
A(clinical(guideline(of(tap(water(irrigation(for(patients(present(to(accident(and(emergency(departments(with(acute(simple(traumatic(lacerations(
Intended(user:(Emergency(nurse(
Target(population:(The(target(populations(are(patients(present(to(AEDs(with(simple(acute(traumatic(lacerations(
Recommendations( ( Grading(
1.#Providing#aesthesis#prior#to#wound#suturing(
1%(Xylocaine(was(given(with(4mg/kg( A(
2.(Using#tap#water#as#irrigation#solution(
Using(tap(water(as(irrigation,(sterile(kidney(dish(or(basin(was(used(to(carry(the(solution(
A(
3.#The#suggested#pressure#of#irrigation#is#between#8#and#45#psi(
Pressure(should(be(more(than(8(psi(and(less(than(40(psi(
B(
4.#Using#a#50ml#syringe#with#18#gauge#angiocatheter#for#irrigation(
A(50(ml(syringe(with(18(gauge(should(be(used(to(generate(the(pressure(of(between(8(and(40(psi(
A(
5.#The#suggested#volume#of#irrigation#solutions#is#more#than#500#ml(
The(volume(should(be(500,(more(than(500(ml(can(used(if(visible(debris(present(
B(
6.(The#suggested#length#of#follow#up#should#be#within#48#hours#to#30#days##(
Follow(up(between(48(hours(and(30(days((because(wound(infection(occur(within(this(period(
B(
7.#Providing#educational#leaflet#of#wound#care#to#patients#upon#discharge(
A(wound(care(leaflet(was(given(to(patient(about(wound(care(
B(
(
Appendix(M((Evidence(based,guideline,
Title,,
A(clinical( guideline(of( tap(water( irrigation( for(patients(present( to( accident( and(
emergency(departments(with(acute(simple(traumatic(lacerations,
The,intended,user,,
This( guideline( is( intended( to( support( emergency( nurse( in( AEDs( who( care(
patients(with(simple(acute(traumatic(lacerations( (
The,target,population,
The(target(populations(are(patients(present(to(AEDs(with(simple(acute(traumatic(
lacerations(
Objectives,
1. To(summarize( the(evidence( from(the( trials( for(patients(present( to(AEDs(
with(simple(acute(traumatic(lacerations(
2. Formulate(clinical(practice(instructions(for(using(tap(water(irrigation(for(
patients(present(to(AEDs(with(simple(acute(traumatic(lacerations(
3. To(promote(costBeffective(wound(management(in(local(AEDs(
(
Recommendations,
Recommendations,1.,Providing,aesthesis,prior,to,wound,suturing,(Grading,
of,recommendation:,A),
In( patients( with( simple( acute( traumatic( lacerations,( it( is( essential( to(
provide( anesthetic( prior( to( suturing( (Weiss( et( al.,( 2013[1+];( Moscati( et( al.,(
2007[2+];(Valente(et(al.,(2003[2B];(Bansal(et(al.,(2002[2+]).( (Providing(aesthesis(
for(minimizing( pain( and( discomfort( during( procedure( is( essential.( All( selected(
trials( also(provide(aesthesis( for(patients( (Weiss( et( al.,( 2013[1+];(Moscati( et( al.,(
2007[2+];(Valente(et(al.,(2003[2B];(Bansal(et(al.,(2002[2+];(Dulecki(et(al,(2005[3];(
Fernandez(et(al.,(2008[1++]).(
Recommendations, 2., Using, tap, water, as, irrigation, solution, (Grading, of,
recommendation:,A),
Irrigation( is( a( wound( cleansing( method( to( remove( bacteria( by( copious(
dilution(of(the(solution.(Tap(water(is(readily(available(in(the(local(AEDs.(Evidence(
suggested( that( tap(water( is( as( effective( as( normal( saline( for( wound( irrigation(
(Weiss(et(al.,(2013[1+];(Moscati(et(al.,(2007[2+];(Valente(et(al.,(2003[2B];(Bansal(
et(al.,(2002[2+];(Dulecki(et(al,(2005[3];(Fernandez(et(al.,(2008[1++]).(
Recommendation,3.,The,suggested,pressure,of,irrigation,is,between,8,and,
45,psi,(Grading,of,recommendation:,B),,
The(suggested(pressure(of( irrigation(should(be(more(than(8(psi(and( less(
than(45(psi.(It(is(achieved(by(using(a(50(ml(syringe(with(18(gauge(angiocatheter.(
High( pressure( irrigation( cause( damage( to( localized( tissue,( hinder( recovery(
process,(result( in(poor(cosmetic(outcome((Weiss(et(al.,(2013[1+];(Moscati(et(al.,(
2007[2+];(Valente(et(al.,(2003[2B];(Bansal(et(al.,(2002[2+];(Dulecki(et(al,(2005[3];(
Fernandez( et( al.,( 2008[1++]).( So( the( optimal( pressure( for( irrigation( should( be(
within(8(and(45(psi(so(as(to(remove(bacteria(without(damage(the(local(tissue(and(
to(promote(the(recovery(process.(
Recommendation,4.,Using,a,50ml,syringe,with,18,gauge,angiocatheter,for,
irrigation,(Grading,of,recommendation:,A),
(( In(order(to(generate(the(optimal(pressure,(a(30B(60(ml(syringe(with(18B19(
gauge(catheter(was(used((Weiss(et(al.,(2013[1+];(Valente(et(al.,(2003[2B];(Bansal(
et(al.,(2002[2+]).(Two(trials(suggested(wounds(irrigated(directly(under(water(tap,(
however,(this(method(may(not(suitable(for(wounds(located(at(special(area(such(
as(trunk((Moscati(et(al.,(2007[2+]).(It(is(suggested(that(using(a(50(ml(syringe(with(
18(gauge(angiocatheter.(
Recommendation,5.,The,suggested,volume,of, irrigation,solutions, is,more,
than,500,ml,(Grading,of,recommendation:,B),
, The( suggested( volume( of( irrigation( is( 500( ml.( (Weiss( et( al.,( 2013[1+];(
Bansal(et(al.,(2002[2+]).(However,( two( trials( suggested(using(more( than(500ml(
irrigation( solution( if( visible( debris( can( be( seen( in( the( wound( (Moscati( et( al.,(
2007[2+];(Valente(et(al.,(2003[2B]).(
Recommendation,6.,The,suggested,length,of,follow(up,should,be,within,48,
hours,to,30,days,,(Grading,of,recommendation:,B),
The(suggested(length(of(followBup(is(at(48(hours(to(30(days((Weiss(et(al.,(
2013[1+];( Moscati( et( al.,( 2007[2+];( Valente( et( al.,( 2003[2B];( Bansal( et( al.,(
2002[2+]).(FollowBup( is(necessary( to(assess(patients’(wound(condition(and( the(
sign( of( infection,( which( include( fever,( erythema,( gross( exudate( or( drainage,(
tenderness.(Dressings(need(to(be(kept(for(intact(for(first(2(days(and(off(stitches(at(
day(5.(The(suggested(length(of(follow(up(should(be(within(48(hours(and(30(days(
since( the(occurrence(of(wound( infection( is(within( this(period.(Early(removal(of(
stitches(regarded(as(infection((Moscati(et(al.,(2007[2+]).((
Recommendation,7.,Providing,educational,leaflet,of,wound,care,to,patients,
upon,discharge,(Grading,of,recommendation:,B),
( Patients( should( receive( wound( care( leaflet( at( discharge.( Continuing(
wound(care(is(essential(to(prevent(wound(infection(until(wound(healed((Moscati(
et( al.,( 2007[2+]).( The( leaflet( should( contain( information( how( to( subsequently(
mange( wound,( provide( knowledge( about( the( complications( of( infection( and(
prevent(further(injury.(
(
!!!!!!!!!!Appendix!N!
Source!from:!Scottish!Intercollegiate!Guidelines!Network!(2008)!SIGN!50.!A!guideline!developer’s!handbook!!
!
Appendix(O(
(
Wound(care(leaflet((Discharge( instruction( for( patients( with( simple( acute( traumatic(lacerations(General(instructions((1. Keep(wound(intact(for(2(days(2. Keep(wound(site(and(surrounding(clean(and(dry(3. Due(to(local(anesthesia,(mild(localized(swelling(after(immediate(closure(regard(as(normal(
4. If(wound(located(at(scalp,(please(do(not(wash(hair(for(2(days.((5. Avoid(strenuous(exercise,(particularly(wound( located(at( joints(such(as(elbow,(knee((
6. If( outer( dressing( become( soil,( please( wash( your( hands( with(soap(
7. Gently( pat( wound( with( clean( gauze( if( outer( dressing( comes(loose(
8. If(you(experience(bleeding(from(wound,(press(the(wound(for(10(minutes((
9. If(bleeding(continue,(apply(ice(bag(over(wound(site(for(10(more(minutes(
((Location:( ( ( ( ( ( ( ( ( ( (Number(of(stitches:( ( ( ( ( ( ( ( (Stitch(will(be(removed(on:(( ( /( /( ( ( ( (((Please(contact(AEDs(immediately(if(you(experience(as(follow:(The(signs(and(symptoms(of(infection(1. Increased( pain( over(wound( site( and( not( controlled( by( use( of(analgesia(such(as(paracetamol(
2. Increased(warmth(on(touch(3. Unpleasant(odor(from(wound(4. Exudate(from(wound(5. Severe(bleeding(from(wound(6. Fever(more(than(38(°C((
(((
Appendix((P(
(
Assessment(form(of(simple(acute(traumatic(lacerations(in(AEDs(
(Patient(characteristics:(Age:(((((((((((((((((((Body(weight:((( ( Date(of(presentation:(( ( ((Medical(history:((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((Injury(mechanism:( ( (((((((( ( ( ((((((((((((((((((((((((((((((((( ((((((( ((((Date(of(follow(up:(( ( ( ((((((((((((((((((((((((((((((((((((((((((( ( ( (((((((((((((((((ATT(injection(given:(1st(dose(,(2(nd((dose,(3(rd(dose,(Immune,(booster(((Wound(characteristics:(( Day(0( Day(2(Wound(location:( ( (Wound(size:(((Length(X(width(X(depth)(Before(suture(After(suture(
(((
cm(X(((((cm(X((((((cm(cm(X(((((cm(X((((((cm(
((
cm(X(((((cm(X((((((cm(cm(X(((((cm(X((((((cm(
Dressing(materials(used:(Solution(
Tap(water/(Normal(saline(irrigation(
Tap(water/(Normal(saline(irrigation(
Name(of(Anesthesia((Dosage:(Route:(
1%(Xylocaine(((((((((ml(
Digital(Block/Field(block/wound(filtration((
1%(Xylocaine(((((((((ml(
Digital(Block/Field(block/(wound(filtration((
Number(of(suture:(Suture(materials:(Stitch(method:(
(Ethlion/(Mersik/(Vicryl(Simple/Buried/Mattress(
(Ethlion/(Mersik/(Vicryl(Simple/Buried/Mattress(
Signs(of(infection:(Redness,(swelling(Pain(score((NRS):(Temperature((>38°C)(Exudate:(
((Y/N)(/10((
(Y/N)(
((Y/N)(/10((
(Y/N)(Antibiotics(given:((Wound(care(leaflet(given:(Wound(culture(taken:(Staff(Signature(((
(Y:((((((((((((((((((((((/N)((
(Y/N)((Y/N)((
(Y:((((((((((((((((((((((/N)((
(Y/N)((Y/N)((
(Extra(date(of(follow(up:((Y:((((((((((((((((((((((/N)(Reason(for(extra(date(of(follow(up:((( ( ( ( ( ((( ( ( ( ( (( ( ( ( ( ( ((((( ( ( ( ( ( (( ( ( ( ( (((
Appendix(Q(
(
Staff(questionnaire(Questionnaire(regarding(using(tap(water(for(wound(irrigation(in(AEDs((You(are(invited(to(fill(the(questionnaire(below(
( ( Strongly(disagree(
Disagree( Neutral( Agree( Strongly(agree(
(1.(
About(workshop(The(workshop(is(well(designed.(
( ( ( ( (
2.( The(workshop(has(provided(up–to(date(knowledge(in(wound(care.(
( ( ( ( (
3.( Taking(this(workshop(has(better(equipped(me(using(tap(water(for(irrigation(is(AEDs.(
( ( ( ( (
4.( The(goals(of(the(workshop(were(made(clear(to(me.( ( ( ( ( (5.( The(use(of(teaching(materials((angiocatheter,(
syringe)(is(appropriate.(( ( ( ( (
6.( The(workshop(has(provided(opportunity(to(integrate(knowledge(into(practice.(
( ( ( ( (
(7.(
About(proposed(innovation(The(proposed(innovation(has(provided(knowledge(that(I(need.(
( ( ( ( (
8.( The(proposed(innovation(has(provided(opportunity(of(evidencePbased(practice(
( ( ( ( (
9( ( ( ( ( ( ((What(do(you(think(about(the(tap(water(quality(in(Hong(Kong?(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ((((((((((((((((((((((((((((((((((((((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ((((((((((((((((((((((((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( (((((((((((((((((((((((((((((Do(you(think(tap(water(is(safe(to(consume?( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( (((((((( (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( ((((((((((((( (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( ((((((((((((( (Did(you(use(tap(water(for(wound(management(before?(If(yes,(in(what(situation?(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( (((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( (((((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( (((((((((((((((((((( (Will(you(consider(using(tap(water(for(irrigation?(If(not,(what(is(your(concern?(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( (( ( (((((((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( (((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ((((((((((( ((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( (((((((((((( ((Other(comments:(((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( (((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((((( ( ( (
~Thanks(for(your(opinions~(
Appendix(R(
(
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