systematic review and meta-analysis of triclosan-coated sutures for the prevention of surgical-site...

Meta-analysis

Systematic review and meta-analysis of triclosan-coatedsutures for the prevention of surgical-site infection

Z. X. Wang1,2, C. P. Jiang1,2, Y. Cao1,2 and Y. T. Ding1,2

1Department of Hepatobiliary Surgery, Afliated Drum Tower Hospital, School of Medicine, Nanjing University, and 2Jiangsu Provinces Key MedicalCentre for Liver Surgery, Nanjing, Jiangsu Province, ChinaCorrespondence to: Professor Y. T. Ding, 321 Zhong Shan Road, Nanjing, Jiangsu Province, China 210008 (e-mail: [email protected])

Background: Surgical-site infections (SSIs) increase morbidity and mortality in surgical patients andrepresent an economic burden to healthcare systems. Experiments have shown that triclosan-coatedsutures (TCS) are beneficial in the prevention of SSI, although the results from individual randomizedcontrolled trials (RCTs) are inconclusive. A meta-analysis of available RCTs was performed to evaluatethe efficacy of TCS in the prevention of SSI.Methods: A systematic search of PubMed, Embase, MEDLINE, Web of Science, the Cochrane CentralRegister of Controlled Trials and internet-based trial registries for RCTs comparing the effect ofTCS and conventional uncoated sutures on SSIs was conducted until June 2012. The primary outcomeinvestigated was the incidence of SSI. Pooled relative risks with 95 per cent confidence interval (c.i.)were estimated with RevMan 5.1.6.Results: Seventeen RCTs involving 3720 participants were included. No heterogeneity of statisticalsignificance across studies was observed. TCS showed a significant advantage in reducing the rateof SSI by 30 per cent (relative risk 070, 95 per cent c.i. 057 to 085; P < 0001). Subgroup analysesrevealed consistent results in favour of TCS in adult patients, abdominal procedures, and clean orclean-contaminated surgical wounds.Conclusion: TCS demonstrated a significant beneficial effect in the prevention of SSI after surgery.

Paper accepted 10 December 2012Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9062

Introduction

Surgical-site infections (SSIs) remain a pervasive problemin modern surgery. According to the US Centers forDisease Control and Prevention (CDC), the overallincidence of SSI is estimated as 28 per cent in the USA1,equivalent to 756 000 patients per year. European countriesreport SSI rates from 15 to 20 per cent, owing to theinherent inconsistencies between studies; however, the truerate of SSI is believed to be underestimated, indicatingthat SSIs represent a signicant problem in Europe aswell2. With its high incidence, SSI places a severe burdenon both patients and healthcare systems. SSIs not onlylead to a signicant increase in morbidity, readmissions,intensive care unit admissions and long-term surgical-sitecomplications, but also result in a greater risk of deathin patients having surgical procedures3. Furthermore,SSIs challenge healthcare systems by requiring additionalhospital bed occupancy, escalated resource costs andincreased loss of working hours2,4,5.

An estimated 4060 per cent of SSIs are preventable6.In spite of the fact that the causes of SSIs are compli-cated, it is well known that bacterial colonization of suturematerials is an important risk factor for the developmentof SSI7,8. Prevention of SSI using sutures impregnatedwith antimicrobial activity has been attempted. Triclosan,a broad-spectrum antiseptic agent, has been employedto provide sutures with antimicrobial activity. Severalproducts have been introduced into the market, includ-ing triclosan-coated polyglactin 910 antimicrobial suture(Vicryl Plus; Ethicon, Johnson & Johnson, Somerville,New Jersey, USA), triclosan-coated poliglecaprone 25antimicrobial suture (Monocryl Plus; Ethicon, John-son & Johnson) and triclosan-coated polydioxanone anti-microbial suture (PDS Plus; Ethicon, Johnson &Johnson).

Both in vitro and in vivo animal experiments have shownthat triclosan-coated sutures (TCS) attenuate bacterialcolonization9,10 and exhibit inhibitory activity to a wide

2013 British Journal of Surgery Society Ltd British Journal of Surgery 2013; 100: 465473Published by John Wiley & Sons Ltd

466 Z. X. Wang, C. P. Jiang, Y. Cao and Y. T. Ding

spectrum of pathogens related to SSIs916 without alteringthe physical properties of sutures, and with no interferencewith the wound-healing process17,18. Several recent clin-ical trials have also reported results showing a benecialeffect of TCS in the prevention of SSIs1924. Nevertheless,the efcacy of TCS remains unproven and controversial,because several studies2529, including a meta-analysis30,have reported no signicant difference in the incidenceof SSI between triclosan-coated and uncoated suturegroups. However, several recent randomized controlledtrials (RCTs)2224,2729,3136 have been reported sincethat meta-analysis. The objective of this systematic reviewwas to analyse currently available RCTs comparing theeffect of TCS with conventional uncoated sutures on theincidence of SSI following surgical procedures.

Methods

Search strategy

The methodology of this study adhered to the guidelinesoutlined in the Preferred Reporting Items for Systematicreviews and Meta-Analyses (PRISMA) statement37 (Fig. 1).A literature search in PubMed, Embase, MEDLINE, Webof Science, Cochrane Central Register of ControlledTrials (CENTRAL) databases was carried out with thecombination of the following search terms: triclosan,antimicrobial, antiseptic, Vicryl Plus, Monocryl Plus,PDS Plus and suture. The search was performed bytwo independent investigators and last updated on 20 June2012; publication date and publication language were not

restricted. Reference lists were examined manually, andinternet-based trial registries38,39 were searched to identifyfurther potentially relevant studies.

Study selection

Studies included in the meta-analysis had to meet all ofthe following criteria: RCT evaluating the efcacy of TCSin humans; if serial studies of the same population fromthe same group were retrieved, only the latest report wasincluded. Two investigators identied trials for inclusionindependently. If there was any disagreement, a seniorinvestigator was invited for discussion until a consensuswas reached.

Risk of bias

Risk of bias and methodological quality of included stud-ies were assessed using the Cochrane Collaboration toolfor assessing risk of bias following the principles of theCochrane Handbook for Systematic Reviews of Interventions40.Overall risk of bias was determined by the followingdomains: random sequence generation; allocation conceal-ment; blinding of participants and personnel; blinding ofoutcome assessment; and incomplete outcome data. Stud-ies with all ve domains rated as low risk were classied ashaving a low risk of bias. Studies with any domain assessedas unclear risk or high risk were classied as unclear or highrisk of bias respectively. A risk-of-bias table was generatedto summarize the results of the assessment.

Potentially relevant RCTs identified and screened for retrievaln = 1673

RCTs excluded n = 1625Irrelevant title or abstract n = 1625

RCTs excluded n = 31Animal experiment n = 9In vitro experiment n = 5Not on triclosan n = 3Protocol of ongoing trial n = 1Review or comment n = 6Not RCT n = 7

RCTs excluded from meta-analysis n = 0

RCTs withdrawn, by outcome n = 0

RCTs retrieved for more detailed evaluationn = 48

Potentially appropriate RCTs to be included in meta-analysisn = 17

RCTs included in meta-analysisn = 17

RCTs with usable information, by outcomen = 17

Fig. 1 PRISMA ow diagram for the study. RCT, randomized controlled trial

2013 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2013; 100: 465473Published by John Wiley & Sons Ltd

Triclosan-coated sutures for prevention of surgical-site infection 467

Table 1 Characteristics of randomized controlled trials involving triclosan-coated sutures

Sample size

Reference Year TCSs Control Study design Blinding Interventions Length of follow-up

Baracs et al.24 2011 188 197 Multicentre RCT Double-blinded PP versus P 30 daysDeFazio et al.25 2005 43 50 Single-centre RCT Double-blinded VP versus V 6 weeksDeliaert et al.47 2009 26 26 Single-centre RCT Double-blinded VP versus V 4 weeksFord et al.48 2005 98 49 Single-centre RCT Open-label VP versus V 80 5 daysGalal and El-Hindawy22 2011 230 220 Multicentre RCT Double-blinded VP versus V 30 days*Isik et al.36 2012 170 340 Single-centre RCT Double-blinded VP versus V 1 monthKhachatryan et al.33 2011 65 68 Single-centre RCT Open-label VP versus uncoated NRMattavelli et al.34 2011 108 109 Multicentre RCT Single-blinded VP versus V 30 daysMingmalairak et al.26 2009 50 50 Single-centre RCT Double-blinded VP versus V 1 yearRasic et al.23 2011 91 93 Single-centre RCT Double-blinded VP versus V NRRozzelle et al.21 2008 46 38 Single-centre RCT Double-blinded VP versus V 6 monthsSeim et al.28 2012 160 163 Single-centre RCT Single-blinded VP versus V 4 weeksSingh et al.32 2010 50 50 RCT Unknown VP versus uncoated 30 daysTurtiainen et al.29 2012 139 137 Multicentre RCT Double-blinded VP/MP versus V/M 30 daysWilliams et al.35 2011 66 61 Single-centre RCT Double-blinded VP/MP versus V/M 6 weeksZhang et al.27 2011 46 43 Multicentre RCT Open-label MP versus silk 30 daysZhuang et al.31 2009 150 300 Single-centre RCT Unknown VP versus P/silk 1224 months

*One year for prosthetic surgery. TCS, triclosan-coated suture; RCT, randomized controlled trial; NR, not reported. PP, PDS Plus; P, PDS; VP,Vicryl Plus; V, Vicryl; MP, Monocryl Plus; M, Monocryl (all from Ethicon, Johnson & Johnson, Somerville, New Jersey, USA).

Data abstraction

Two investigators independently extracted data from theincluded trials. Characteristics of eligible studies wereextracted, including publication date, publication status,demographic characteristics of participants, interventionsof trials, sample size of intervention groups, study design,surgery type, traditional classication of incision andfollow-up period. Outcome data were extracted as eventsper total number at risk in both the experimental andcontrol arms. The two investigators cross-checked the dataabstraction results and reached a consensus on all extracteddata. If different results were generated, they would checkthe data and have a discussion to arrive at a consensus. Asenior investigator would be invited to the discussion ifdisagreement still existed. Missing data were obtained bycontacting the corresponding author or by adopting thedata as reported in the previous systematic review30.

Primary outcome endpoint of the meta-analysisand subgroup analyses

The primary outcome investigated was the incidence ofSSI. All studies with eligible data were pooled to achievean overall estimation of the effect of TCS on the incidenceof SSIs compared with uncoated sutures.

To verify further the result of overall estimation in morespecied populations with relatively uniform background,the following subgroup analyses stratied by characteristicsof participants and interventions were performed: age ofparticipants, wound contamination classied by traditional

incision classication, and surgery type. Comparisonsexclusively between Vicryl Plus and Vicryl were alsoanalysed to determine whether triclosan enhanced theantimicrobial property of Vicryl, which represents one ofthe most frequently used suture materials worldwide.

According to the CDC, SSIs are dened as infectionsoccurring within 30 days after surgical procedures (orwithin 1 year if an implant is left in place after theprocedure)41. Therefore, studies were further stratiedby follow-up period within 1 month or longer than1 month to investigate whether the length of follow-upof individual trials inuenced the assessment of SSI. Inaddition, subgroup analyses by risk of bias and publicationstatus were conducted to evaluate further the credibilityand stability of this meta-analysis.

Publication bias

Publication bias of the literature was assessed using funnelplots. An asymmetrical plot suggested possible publicationbias.

Statistical analysis

Quantitative data synthesis was performed using RevMan5.1.642. The existence of statistical heterogeneity amongthe studies was checked with the 2-based Q test.P > 0100 for Q test indicated that no signicant het-erogeneity existed among studies43. If no signicantheterogeneity was detected, the pooled relative risks



(RRs) with corresponding 95 per cent condence interval(c.i.) were estimated by the xed-effects model (Man-telHaenszel method)44. Otherwise, the random-effectsmodel (DerSimonianLaird method) was employed togenerate pooled RRs45. The amount of heterogeneity wasmeasured by the I2 statistic46. An I2 value of less than25 per centwas dened as lowheterogeneity; I2 between 25and 50 per cent was considered representative of moderateheterogeneity; and I2 greater than 50 per cent representedhigh heterogeneity. The signicance of pooled RRs wasdetermined by the Z test, and P < 0050 was consid-ered statistically signicant. Forest plots were generated tosummarize the results of individual meta-analyses.

Sensitivity analysis was carried out by deleting one studyeach time to examine the inuence of individual data setson the pooled RRs.

Results

Of 1673 citations identied from the database search andother sources, 17 eligible RCTs involving a total of 3720participants were included in the meta-analysis. The owdiagram of study identication is shown in Fig. 1.

The sample size of included RCTs ranged from 52 to510 participants; 1726 participants were randomized to theTCS group and 1994 to the uncoated sutures group, withfollow-up periods varying from 4 weeks to 24 months. TheTCS examined included Vicryl Plus, Monocryl Plus andPDS Plus. Detailed characteristics of the included studiesare shown in Table 1.

The qualities and risks of bias of the included RCTsare summarized in Table 2. Three trials were considered ashigh quality and low risk of bias, and six were classiedas low quality and high risk of bias. Owing to insufcientinformation regarding detailed study design and lack ofevidence to prove the existence of risk of bias, the remainingeight RCTswere classied as moderate quality and unclearrisk of bias. Overall, the qualities of the included studieswere acceptable with moderate risk of bias.

Effect of triclosan-coated versus uncoated sutureson surgical-site infections

Seventeen trials reported the incidence of SSIs inTCS and control groups2129,3136,47,48. Meta-analysis ofthese RCTs favoured TCS with a pooled RR of 070(95 per cent c.i. 057 to 085; P < 0001) without statisticalheterogeneity (P for Q test = 0129, I2 = 29 per cent),indicating that the use of TCS resulted in a signicantreduction in the incidence of SSI (Fig. 2). Sensitivityanalysis reected that no individual data set signicantlyaltered heterogeneity and the pooled RR of SSI, suggestingthat the results from this meta-analysis were stable.

Subgroup analyses

In subgroup analyses stratied by characteristics ofparticipants and interventions, the benecial effect ofTCS on the prevention of SSI was consistently signi-cant in adult patients, abdominal surgery, and clean or

Table 2 Risk of bias summary

Reference

Random sequencegeneration

(selection bias)

Allocationconcealment(selection bias)

Blinding of participantsand personnel

(performance bias)

Blinding ofoutcome assessment

(detection bias)

Incompleteoutcome data(attrition bias)

Selectivereporting

(reporting bias)Otherbias

Baracs et al.24 + ? ? ? + +DeFazio et al.25 ? + + + ? + Deliaert et al.47 ? + + + + +Ford et al.48 ? ? + +Galal and El-Hindawy22 + + + + + + +Isik et al.36 ? ? ? ? + ? +Khachatryan et al.33 ? ? ? ? ?Mattavelli et al.34 ? ? ? ? ?Mingmalairak et al.26 + + + + + ? +Rasic et al.23 + + ? ? + ? ?Rozzelle et al.21 ? + + + + + +Seim et al.28 ? + + + +Singh et al.32 ? ? ? ? ? ? ?Turtiainen et al.29 ? + + + + + +Williams et al.35 + + + + + +Zhang et al.27 + + + + Zhuang et al.31 ? ? ? + + ? ?

+, Low risk; ?, unclear risk; , high risk.



002Favours triclosan Favours control

01 1 10 50

Reference

Baracs et al.24

DeFazio et al.25Deliaert et al.47

Ford et al.48

Galal and El-Hindawy et al.22

Isik et al.36

Khachatryan et al.33

Mattavelli et al.34

Mingmalairak et al.26

Rozzelle et al.21

Seim et al.28

Singh et al.32

Turtiainen et al.29

Williams et al.35

Zhang et al.27

Zhuang et al.31

Triclosan

SSIControl Weight (%) Relative risk Relative risk

23 of 1884 of 430 of 263 of 98

17 of 2309 of 1706 of 65

11 of 1085 of 504 of 912 of 46

16 of 1606 of 50

31 of 13910 of 662 of 460 of 150

24 of 1974 of 500 of 260 of 49

33 of 22019 of 34014 of 6812 of 1094 of 50

12 of 938 of 38

17 of 16316 of 5030 of 13714 of 615 of 43

15 of 300

108 100 (059, 172)116 (031, 437)

354 (019, 6712)049 (028, 086)095 (044, 205)045 (018, 110)093 (043, 201)125 (036, 438)034 (011, 102)021 (005, 092)096 (050, 183)038 (016, 088)102 (065, 159)066 (032, 137)037 (008, 183)006 (000, 107)

070 (057, 085)

Not estimable17

031555863551855407774

139672448

149 of 1726Total

Heterogeneity: 2 = 2126, 15 d.f., P = 0129; I2 = 29%Test for overall effect: Z = 361, P < 0001

227 of 1994 100

Rasic et al.23

Fig. 2 Forest plot for meta-analysis comparing the incidence of surgical-site infection (SSI) in triclosan-coated and uncoated (control)suture groups. A MantelHaenszel xed-effects model was used for meta-analysis. Relative risk values are shown with 95 per centcondence intervals

Table 3 Summary of subgroup analysis

Surgical-site infectionNo. of No. of Relative P for Q

studies participants TCSs Control risk P* test I2 (%)

Overall 17 3720 149 of 1726 227 of 1994 070 (057, 085)


00220

15

10

05

0

Stan

dard

erro

r of l

og(R

R)

1 10Log(RR)

5001

Fig. 3 Funnel plot for the evaluation of publication bias. RR,relative risk. A symmetrical funnel plot suggests no obviouspublication bias

clean-contaminated incisions (Table 3). This advantageouseffect was not observed for paediatric patients, contami-nated/dirty incisions, breast surgery or cardiac surgery.

For RCTs that exclusively studied the efcacy of VicrylPlus versus Vicryl, pooled estimation favoured VicrylPlus (RR 070, 95 per cent c.i. 053 to 094; P = 0016).Moreover, the advantage of TCS over conventional sutureswas consistent regardless of length of follow-up.

In analysis stratied by risk of bias, signicant statisticalheterogeneity was detected in the subgroup of trials with anunclear risk of bias. The superiority of TCS was signicantin low-risk studies (RR 060, 039 to 090; P = 0015),whereas studies with unclear risk showed a trend towards areduced incidence of SSI in the TCS group with a marginalP value of 0051 (RR 057, 032 to 100). The estimation ofstudies with a high risk of bias failed to nd an advantagefor TCS over uncoated sutures (RR 085, 062 to 118;P = 0332). Furthermore, subgroup analysis carried outin studies published as full-length articles or conferenceabstracts was consistent with the overall estimation.

Publication bias

The distribution of studies in funnel plot was symmetrical.No evidence for a signicant publication bias in this meta-analysis was found (Fig. 3).

Discussion

This systematic review and meta-analysis found that useof TCS resulted in a 30 per cent reduction in the risk ofSSI, especially in adult patients, abdominal procedures,and clean or clean-contaminated incisions. TCS may be

favourable in clinical application to reduce the incidence ofSSI and the additional medical costs associated with SSIs.

Suture materials play an important role in thedevelopment of SSI by providing a local surface for theadherence of microorganisms49. Once pathogens havecolonized suture materials, a biolm may subsequentlybe formed to promote the attachment and reinforcethe resistance against attack from the hosts immunesystem and antimicrobial treatment, thus predisposingthe wound to infection5052. Accordingly, the strategyof coating sutures with antimicrobial agents, such as silveror antibiotics, to reduce the risk of suture-related SSI hasbeen considered since the 1950s5355. Triclosan, a broad-spectrum antiseptic with an established safety prole, hasbeen used widely in pharmaceutical and hygiene productsfor human use for over 30 years56,57. Recently, TCSmaterials with antimicrobial activity have been developedto counter the challenge from SSIs.

Following the promising results from in vitro and in vivoexperiments, various clinical trials have demonstrated theadvantage of TCS over conventional uncoated sutures inthe prevention of SSI. However, results from individualRCTs have been inconclusive and controversial, indicatingthat the limited sample size of individual RCTs may beunderpowered to detect the true effect of TCS. Accordingto calculations, demonstration of a statistically signicantdifference between TCS and control groups in SSI ratesat 2 and 6 weeks after breast surgery would requireapproximately 13 and three times respectively the numberof participants actually randomized in the same trial35.Meta-analysis may indeed be helpful in such circumstancesas it involves the quantitative synthesis of data frommultiple RCTs, thereby providing a more comprehensiveestimation with greater statistical power58. With data from3720 surgical patients, this systematic review conrmedthe benecial effect of TCS in SSI prevention.

Application of TCS may have a signicant impact oncurrent clinical practice by reducing not only morbidityand risk of death in surgical patients, but also overallindirect costs59,60. Previous reports have demonstratedconsiderable economic loss incurred by SSIs60,61. Withonly a small additional expense, TCS could signicantlydecrease both the risk of readmission and the length ofhospital stay, and subsequently reduce excess costs onmedical systems19,61. The results of this systematic reviewjustify the routine use of TCS, especially in adult patients,abdominal procedures, and clean or clean-contaminatedincisions.

The conclusion of the present meta-analysis is differentfrom that of a previous meta-analysis on the subject30. Theother study included seven RCTs and found no benet for



the use of TCS. However, most of the studies analysedwere of low quality and high heterogeneity. The limitednumber of trials also prevented the authors from exploringfurther the potential effect of TCS in specic populations.In contrast, the present systematic review andmeta-analysisprovided updated comprehensive estimation of the efcacyofTCSwith latest evidence from currently available RCTs.Ten newly published studies22,23,28,29,3136 and updateddata from two other trials24,27 have expanded the totalsample size from 836 to 3720, signicantly improving thepower of this meta-analysis. The quality of trials alsoimproved from one with low risk, three with unclearrisk and three with high risk, to three studies with lowrisk, eight with unclear risk and six with high risk. Inthe present meta-analysis, subgroup analysis revealed aprogressive trend of statistical signicance in accordancewith the improvement of study quality, which may atleast partly explain the competing conclusion with theprevious study30 and again emphasizes the importanceof methodological quality of RCTs. Moreover, the 17studies included in this meta-analysis could be categorizedby similar clinical settings, thus enabling the authorsto improve the problem of heterogeneity by subgroupanalyses. Results conrmed by subgroup analyses should bemore reliable and more informative, because they describethe efcacy of TCS in a similar clinical situation withmore uniform background and less clinical heterogeneity.Importantly, multiple subgroup analyses on quality ofstudy design and potential risk of bias were conductedin this systematic review, and the consistent results furtherconrm the stability and reliability of the results of thepresent meta-analysis.

Of note, caution should be exercised when interpretingthe results owing to some limitations of this systematicreview and meta-analysis. First, the quality of includedtrials is still not fully satisfactory. As the reliability ofa meta-analysis is determined largely by the quality ofincluded trials, the results of this meta-analysis should beinterpreted cautiously. Further well designedRCTs of highmethodological quality are needed. Second, postoperativeSSI is a clinical diagnosis that is highly dependenton assessors. Only ve of the trials22,27,29,35,36 clearlydened the diagnostic criteria for SSI developed by theCDC62, whereas the remaining studies did not adhere tothese criteria. This may introduce clinical heterogeneity,so that potential bias cannot be ruled out. Moreover,although all of the included studies reported the incidenceof SSI following surgical procedures as an endpoint,three did not use SSI as the primary outcome27,47,48.Heterogeneity of outcome reporting could bring potentialbias and may distort the data from these trials. Third,

the trials included in this meta-analysis were conducted indifferent settings of participants and for varying surgicalprocedures. The results should be interpreted with cautionand specied clinical scenarios should be considered.Finally, insufcient individual patient data prevented theauthors from conducting a meta-analysis based on detailedindividual information. Stratication by risk factors forSSI such as diabetes, steroids and smoking was also notpossible owing to lack of available data. These factors couldinuence the estimation by interacting with the effect ofTCS.

Acknowledgements

Z.X.W. and C.P.J. contributed equally to this work. Thisstudy was supported by the Grants for Key Clinical Centresof Institutes (no. ZX201105) and Science Fund of Ministryof Health of China (no. LW201008).Disclosure: The authors declare no conict of interest.

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