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Available online at www.sciencedirect.com

ScienceDirect

journal homepage: www.JournalofSurgicalResearch.com

Efficacy of triclosan-coated sutures for reducing


risk of surgical site infection in adults:
a meta-analysis of randomized clinical trials

Jiao Guo, MD,a,1 Ling-Hui Pan, MD, PhD,b,1 Yun-Xi Li, MD,c,1
Xiang-Di Yang, MD,a Le-Qun Li, MD, PhD,d Chun-Yan Zhang, MD,a,*
and Jian-Hong Zhong, MDd,**
a
Experimental Department, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, PR China
b
Anesthesia Department, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, PR China
c
Cancer Registry Department, People’s Hospital of Fusui County, Fusui, PR China
d
Hepatobiliary Surgery Department, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, PR China

article info abstract

Article history: Background: Surgical site infection (SSI) is the third most frequent type of nosocomial in-
Received 30 May 2015 fections. Triclosan-coated sutures are often used to reduce the risk of SSI, but studies
Received in revised form examining this have given conflicting results. Therefore, this meta-analysis was performed
19 September 2015 to assess the efficacy of triclosan-coated sutures for reducing risk of SSI in adults.
Accepted 7 October 2015 Methods: PubMed, EMBASE, Google Scholar, and ClinicalTrials.gov were searched to identify
Available online 23 October 2015 randomized clinical trials evaluating triclosan-coated sutures for preventing SSI on pa-
tients 18 y or older.
Keywords: Results: Thirteen randomized clinical trials involving 5256 participants were included.
Surgical site infection Triclosan-coated sutures were associated with lower risk of SSI than uncoated sutures across
Triclosan all surgeries (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.65e0.88, P < 0.001). Similar
Suture proportions of patients experienced wound dehiscence with either type of suture (RR 0.97,
Antimicrobial 95% CI 0.49e1.89, P ¼ 0.92). Subgroup analysis showed lower risk of SSI with triclosan-coated
Antiseptic sutures in abdominal surgeries (RR 0.70, 95% CI 0.50e0.99, P ¼ 0.04) and group with prophy-
lactic antibiotic (RR 0.79, 95% CI 0.63e0.99, P ¼ 0.04). However, such risk reduction was not
observed in cardiac surgeries, breast surgeries, or group without prophylactic antibiotic.
Conclusions: Triclosan-coated sutures can decrease the incidence of SSI in abdominal sur-
geries and might not interfere with wound healing process. Nevertheless, further studies
are needed to examine whether triclosan-coated sutures are effective at preventing SSI in
non-abdominal surgeries and to further study the interaction of antibiotic prophylaxis with
triclosan-coated sutures.
ª 2016 Elsevier Inc. All rights reserved.

* Corresponding author. Experimental Department, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd. #71, Nanning
530021, PR China. Tel.: þ86 771-5330855 (office); fax: þ86 771-5312000.
** Corresponding author. Hepatobiliary Surgery Department, Affiliated Tumor Hospital of Guangxi Medical University, He Di Rd. #71,
Nanning 530021, PR China. Tel.: þ86 771-5330855 (office); fax: þ86 771-5312000.
E-mail addresses: zcy_263@163.com (C.-Y. Zhang), zhongjianhong66@163.com (J.-H. Zhong).
1
These authors contributed equally to this work.
0022-4804/$ e see front matter ª 2016 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.jss.2015.10.015
106 j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7

1. Introduction Items for Systematic Reviews and Meta-Analyses statement


[30].
Surgical site infection (SSI) is a persistent challenge in modern
surgery around the world. According to the US Centers for
Disease Control (CDC) National Nosocomial Infections Sur- 2.1. Search strategy
veillance system, SSI is the third most frequent nosocomial
infection in the United States, accounting for 14%e16% of in- Two authors (J.G. and J.H.Z.) independently searched PubMed,
fections among hospitalized patients and 38% of infections in EMBASE, Google Scholar, and Clinicaltrials.gov using the
surgical patients [1,2]. In European countries, the estimated following keywords: triclosan, antimicrobial, antiseptic, surgical
SSI incidence range varies from 1.5% to 20%, owing to differ- site infection, surgical site infections, and suture. Searches were
ences among studies regarding how surgical procedures are not restricted based on publication type, language, or date.
conducted and how SSI data are collected [3]. The reference lists of identified studies and review articles
SSI leads not only to substantial morbidity and mortality, were manually searched to identify additional potentially
but also to longer hospital stays and greater health-care costs eligible studies.
[4,5]. SSI can also influence patient quality of life and work
productivity because of time spent in hospital.
2.2. Study selection
Although several risk factors have been associated with SSI
[1,2,6], contamination of suture materials appears to be one of
To be included in our meta-analysis, studies had to be RCTs
the most frequent causes [7e9], whereas a less frequent cause
with patients aged 18 y or older comparing the clinical efficacy
is the presence of contaminated foreign material in the
of triclosan-coated sutures with traditional uncoated sutures
wound. Once the suture material is contaminated, the prog-
for one or more types of surgery. For studies involving over-
ress of SSI becomes complicated, and local anti-infection
lapping or identical patient populations, only the most recent
mechanisms are often ineffective [10,11] because microbes
study was included. Studies were included only if they were
in the sutures can reinfect the site even after cleaning or
full-length original research reports, not abstracts, or non-
systemic antibiotic treatment.
peer-reviewed RCTs. Studies were excluded if anti-SSI in-
To reduce the risk of suture contamination and therefore of
terventions were undertaken besides using coated sutures.
SSI, suture materials can be coated with antibacterial agents
Studies were assessed for eligibility and selected indepen-
such as triclosan (polychloro phenoxy phenol), a broad-
dently by two authors (J.G. and J.-H.Z.), with disagreements
spectrum antimicrobial that affects gram-positive and gram-
resolved by discussion.
negative bacteria [8,12,13]. Triclosan has been widely used
for more than 30 y in consumer and health-care products,
including toothpaste, soap, hand hygiene products, and sur- 2.3. Data extraction
gical scrubs [14]. It appears to be safe and effective against
bacteria [13,14]. Since the US Food and Drug Administration Two authors (J.G. and J.H.Z.) independently extracted the
approved in 2002, the first coated surgical suture, which was following data from included RCTs: first author’s name, coun-
coated with antimicrobial polyglactin 910 (VICRYL Plus, Ethi- try, date of publication, total numbers of patients and numbers
con, NJ), a variety of triclosan-coated sutures have been in each suture group, study design and blinding, surgical
licensed and are widely used, including triclosan-coated procedures, operating time, length of follow-up, incidences of
poliglecaprone 25 antimicrobial suture (MONOCRYL Plus; SSI and wound dehiscence, and whether SSI was defined
Ethicon) and triclosan-coated polydioxanone antimicrobial according to US CDC criteria [1]. Outcomes based on intention-
suture (PDS Plus; Ethicon). to-treat analyses were extracted wherever possible; if
Numerous studies in vivo and in vitro have shown that outcomes were not reported on an intention-to-treat basis,
triclosan-coated sutures are associated with significantly then they were extracted on a per-protocol basis. Discrep-
lower risk of SSI than uncoated sutures [15e21]. On the other ancies in data extracted by each author were resolved by
hand, some clinical trials have suggested that coating sutures discussion.
with triclosan does not reduce risk of SSI [22e28], and that
such sutures may fail more often than conventional uncoated
ones, leading to wound dehiscence [29]. 2.4. Risk of bias and quality assessment
To provide a comprehensive assessment of the available ev-
idence, we meta-analyzed randomized clinical trials (RCTs) As described in detail previously [31], assessment of risk of
comparing triclosan-coated with uncoated sutures for prevent- bias and methodological quality was conducted according
ing SSI and wound dehiscence after various surgeries in adults. to Cochrane Handbook for Systematic Reviews of Intervention
[32], which contains several domains concerning bias of
selection, performance, detection, attrition, and reporting.
Studies with low risk of bias for all key domains were
2. Methods considered to be of ow risk of bias, whereas studies with
unclear or high risk of bias for one or more key domains
This meta-analysis was carried out and reported based as were considered to be of unclear or high risk of bias,
closely as possible on the guidelines of the Preferred Reporting respectively.
j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7 107

2.5. Statistical analysis Sensitivity analyses were carried out by repeating meta-
analyses after systematically deleting each of the pooled
The primary outcome was incidence of SSI, and secondary studies and examining whether the results changed signifi-
outcomes were occurrence of wound dehiscence, qualitative cantly. Funnel plots were generated, and Egger’s test [33e35]
analysis of treatment costs, length of hospital stay, operating was performed to assess the potential for publication bias in
time, and causative organism. Pooled data extracted from our meta-analysis.
eligible trials were quantitatively analyzed using RevMan 5.2
software (Cochrane Collaboration). Heterogeneity among
pooled studies was tested using the chi-squareebased Q test 3. Results
and the I2 statistic. P > 0.1 for the Q test indicated no statis-
tically significant heterogeneity among included studies. In 3.1. Description of studies
the event that P  0.1, the extent of heterogeneity was
assessed using the I2 value: an I2 less than 25% was defined as Systematic searches of the literature identified 438 studies
low heterogeneity; I2 between 25% and 50%, moderate het- about triclosan-coated sutures, of which 378 were excluded on
erogeneity; and I2 greater than 50%, high heterogeneity. the basis of the titles and abstracts. Of the remaining 60
Pooled studies were meta-analyzed using a fixed-effect model studies, 38 were excluded because they were not original re-
in the absence of significant heterogeneity among studies; ports of clinical RCTs. Two publications [27,36] published in
otherwise, a random-effect model was used. Risk ratios (RRs) different languages were based on the same population, so
and associated 95% confidence intervals (CIs) were used to they were considered one study. Four RCTs [37e40] that were
estimate dichotomous outcomes. Meta-analyses were dis- apparently published only as abstracts were excluded, as were
played graphically in the form of forest plots, with P < 0.05 two RCTs [41,42] involving pediatric patients. Two RCTs [43,44]
considered to be statistically significant. Subgroup analyses were further excluded owing to low level of RCT. In the end, 13
were performed based on length of follow-up, antibiotic pro- RCTs [23e25,27e29,45e51] were included in the meta-
phylaxis, surgery type, and suture type. analysis. The process of study selection is shown in Figure 1.

Fig. 1 e PRISMA flow diagram of study identification, screening and inclusion. PRISMA, Preferred Reporting Items for
Systematic Reviews and Meta-Analyses. (Color version of figure is available online.)
108
Table 1 e Characteristics of RCTs comparing rates of SSI site infection in adult patients treated with triclosan-coated or uncoated sutures.
Study Country Sample size Study Blinding Suture types Surgical procedure Wound CDC Length of
(Study/control) design (coated/uncoated) description criteria follow-up

Deliaert et al. 2009 [29] Netherlands 52 (26/26) Single-center Double VICRYL Plus/VICRYL Breast reduction Clean NR 4 wk
Baracs et al. 2011 [27] Hungary 385 (188/197) Multicenter NR PDS plus/PDS Ⅱ Colorectal surgery Clean-contaminated NR 30 d
Galal and Egypt 450 (230/220) Multicenter Double VICRYL Plus/VICRYL General surgery (78%), Clean, Y 30 d (1 y if
El-Hindawy 2011 [45] plastic surgery (19%), Clean-contaminated prosthesis)

j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7
other (3%) Contaminated
Rasic et al. 2011 [46] Croatia 184 (91/93) Single-center Double VICRYL Plus/VICRYL Colorectal surgery NR NR NR
Williams et al. UK 150 (75/75) Single-center Double VICRYL Plus/VICRYL; Breast cancer surgery NR Y 6 wk
2011 [47] MONOCRYL Plus/MONOCRYL
Zhang et al. 2011 [48] China 101 (51/50) Multicenter Open-label VICRYL Plus/Chinese Modified radical Clean Y 90 d
silk suture mastectomy
Isik et al. 2012 [24] Turkey 510 (170/340) Single-center Double VICRYL Plus/VICRYL Cardiac surgery NR Y 30 d
Seim et al. 2012 [25] Norway 323 (160/163) Single-center Open-label VICRYL Plus/VICRYL Vein harvesting NR NR 4 wk
for CABG
Turtiainen et al. Finland 276 (139/137) Multicenter Double VICRYL Plus/VICRYL; Lower limb NR Y 30 d
2012 [28] MONOCRYL Plus/MONOCRYL revascularization
Justinger et al. Germany 856 (485/371) Single-center Double PDS Plus/PDS Ⅱ Laparotomy (various Clean Y 2 wk
2013 [49] abdominal procedures) Clean-contaminated
Contaminated
Septic
Nakamura et al. Japan 410 (206/204) Single-center Double VICRYL Plus/VICRYL Colorectal surgery Clean Y 30 d
2013 [50] Clean-contaminated
Contaminated
Dirty
Thimour-Bergstrom Sweden 374 (184/190) Single-center Double VICRYL Plus/VICRYL; Leg incision after vein NR Y 60 d
et al. 2013 [51] MONOCRYL Plus/MONOCRYL harvesting for CABG
Diener et al. 2014 [23] Germany 1185 (587/598) Multicenter Double PDS Plus/PDS Ⅱ Elective midline Clean Y 30 d
abdominal laparotomy Clean-contaminated
Contaminated
Dirty

CABG ¼ coronary artery bypass grafting; CDC criteria ¼ US Centers for Disease Control and Prevention criteria for definition of SSI; MONOCRYL ¼ poliglecaprone 25 suture; MONOCRYL Plus ¼ triclosan-
coated poliglecaprone 25 antimicrobial suture; NR ¼ not reported; PDS ¼ polydioxanone suture; PDS Plus ¼ triclosan-coated polydioxanone antimicrobial suture; VICRYL ¼ polyglactin 910 suture;
VICRYL Plus ¼ triclosan-coated polyglactin 910 antimicrobial suture; Y ¼ reported.
j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7 109

Table 2 e Risk of bias summary.


Study Random Allocation Blinding Blinding of Incomplete Selective Other
sequence concealment of participants outcome outcome data reporting bias
generation (selection and personnel assessment (attrition (reporting
(selection bias) (performance (detection bias) bias)
bias) bias) bias)

Deliaert et al. 2009 [29] ? þ þ þ þ  þ


Baracs et al. 2011 [27] þ ? ? ?  þ þ
Galal and El-Hindawy2011 [45] þ þ þ þ þ þ þ
Rasic et al. 2011 [46] þ þ ? ? þ ? ?
Williams et al. 2011 [47] þ þ þ þ þ  þ
Zhang et al. 2011 [48] þ þ   þ þ 
Isik et al. 2012 [24] ? ? ? ? þ ? þ
Seim et al. 2012 [25] ? þ   þ þ þ
Turtiainen et al. 2012 [28] ? þ þ þ þ þ þ
Justinger et al. 2013 [49] þ þ þ þ  þ þ
Nakamura et al. 2013 [50] þ þ þ þ þ þ þ
Thimour-Bergstrom et al. 2013 [51] þ þ þ þ þ þ þ
Diener et al. 2014 [23] þ þ þ þ þ þ þ

þ ¼ low risk;  ¼ high risk; ? ¼ unclear risk.

Altogether, the included studies in our meta-analysis Table 2 summarizes assessment results of risk of bias and
involved 5256 adult participants, 2592 of whom were ran- methodological quality. Of the 13 studies included, nine trials
domized to be treated with triclosan-coated sutures, and reported random sequence generation and selective report-
2664 to be treated with uncoated sutures. Six trials ing, 11 trials reported allocation concealment and incomplete
[24,25,29,45,46,50] compared VICRYL Plus sutures with VICRYL outcome data, and 10 trials reported blinding of participants,
sutures, three trials [23,27,49] compared PDS Plus sutures with personnel, and outcome assessment. According to Cochrane
PDS Ⅱ sutures, whereas the remaining four trials [28,47,48,51] Handbook for Systematic Reviews of Intervention [32], five RCTs
compared two types of coated sutures with the correspond- [23,45,47,50,51] were assessed to be high quality, four RCTs
ing uncoated sutures. Eight RCTs [24,25,29,46,47,49e51] were [25,27,48,49] were considered to be low quality, whereas the
conducted at a single center, whereas five [23,27,28,45,48] remaining four RCTs [24,28,29,46] were classified to be
were conducted at multiple centers. Follow-up ranged from moderate-quality. Consequently, the qualities of included
2 wk to 1 y, with most studies reporting outcomes at 30 d in RCTs were acceptable.
accordance with CDC criteria. Five RCTs [23,27,46,49,50]
involved abdominal surgeries, three RCTs [24,25,51] regarded 3.2. Risk of SSI with triclosan-coated versus uncoated
cardiac surgeries, three RCTs [29,47,48] concerned breast sutures
surgeries, and two RCTs [28,45] referred to other surgeries.
Detailed characteristics of the included studies are All the included RCTs [23e25,27e29,45e51] reported SSI out-
summarized in Table 1. comes. Triclosan-coated sutures significantly reduced the

Fig. 2 e Forest plot of meta-analysis comparing the incidence of SSI in patient groups treated with triclosan-coated or
uncoated sutures. (Color version of figure is available online.)
110 j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7

Table 3 e Summary of subgroup analyses stratified by length of follow-up, type of surgery or type of suture, and antibiotic
prophylaxis.
Group or subgroup No. of No. of SSI, n/N Relative risk of P* I2 (%)
studies participants SSI (95% CI)
Coated Uncoated
sutures sutures

Overall 13 5256 262/2592 349/2664 0.76 (0.65e0.88) 0.0002 25


Follow-up length
>30 d 3 625 35/310 57/315 0.63 (0.43e0.93) 0.02 0
30 d 9 4447 223/2191 280/2256 0.79 (0.63e0.98) 0.03 34
Not reported 1 184 4/91 12/93 0.34 (0.11e1.02) 0.05 d
Type of surgery
Abdominal 5 3020 154/1557 193/1463 0.70 (0.50e0.99) 0.04 52
Breast 3 303 12/152 19/151 0.64 (0.33e1.26) 0.20 0
Cardiac 3 1207 48/514 74/693 0.77 (0.54e1.08) 0.13 0
Other 2 726 48/369 63/357 0.72 (0.35e1.48) 0.37 75
Antibiotic prophylaxis
Received 8 3769 211/1931 254/1838 0.79 (0.63e0.99) 0.04 29
Not received 2 426 23/210 38/216 0.63 (0.39e1.01) 0.05 d
Not reported 3 1061 28/451 57/610 0.60 (0.38e0.94) 0.03 5
Type of suturey
VICRYL plus versus VICRYL 6 1929 55/883 100/1046 0.62 (0.43e0.90) 0.01 23
PDS plus versus PDS 3 2426 141/1260 162/1166 0.81 (0.59e1.13) 0.22 50
Mixed suture 4 901 66/449 87/452 0.78 (0.58e1.04) 0.09 0

PDS ¼ polydioxanone suture; VICRYL ¼ polyglactin 910 suture; VICRYL Plus ¼ triclosan-coated polyglactin 910 antimicrobial suture.
*
Based on the Z test.
y
Suture types are defined in Table 1.

incidence of SSI (RR 0.76, 95% CI 0.65e0.88, P < 0.001), and this In analysis stratified by antibiotic prophylaxis, the risk of
meta-analysis was not affected by significant heterogeneity SSI was significantly decreased for RCTs with patients who
(P ¼ 0.20, I2 ¼ 25%; Fig. 2). Sensitivity analysis further showed received antibiotic [23,25,27,28,46,47,49,50] (RR 0.79, 95% CI
that deleting any single data set did not significantly affect the 0.63e0.99, P ¼ 0.04). According to data of two RCTs with pa-
degree of heterogeneity or the pooled RR for risk of SSI. tients who did not receive antibiotic [29,51], the risk of SSI did
Subgroup analysis was performed according to participant not decrease with a bordered P value (RR 0.63, 95% CI
characteristics and interventions, including length of follow- 0.39e1.01, P ¼ 0.05). The sensitivity analysis showed that the
up, antibiotic prophylaxis, and type of surgery or sutures risk of SSI became similar between the two groups when the
(Table 3; Fig. 3). In analysis stratified by surgery type, the study of Justinger et al. [49] (RR 0.86, 95% CI 0.72e1.03, P ¼ 0.11),
beneficial effect of triclosan-coated sutures was significant in Rasic et al. [46] (RR 0.83, 95% CI 0.68e1.01, P ¼ 0.06), Williams
abdominal surgeries based on data pooled from five trials et al. [47] (RR 0.79, 95% CI 0.62e1.01, P ¼ 0.06) or Nakamura et al.
[23,27,46,49,50] (RR 0.70, 95% CI 0.50e0.99, P ¼ 0.04). In contrast [50] (RR 0.83, 95% CI 0.67e1.03, P ¼ 0.09) was removed. The
to the case with abdominal surgeries, the risk of SSI was result of sensitivity analysis in group with use of prophylactic
similar with either type of suture in cardiac surgeries antibiotic is summarized in Table 4, and the detailed infor-
[24,25,51] (RR 0.77, 95% CI 0.54e1.08, P ¼ 0.13), breast surgeries mation of antibiotic prophylaxis is summarized in Table 5.
[29,47,48] (RR 0.64, 95% CI 0.33e1.26, P ¼ 0.20), and other sur-
geries [28,45] (RR 0.72, 95% CI 0.35e1.48, P ¼ 0.37). 3.3. Risk of wound dehiscence with triclosan-coated
In analysis stratified by suture type, data pooled from six versus uncoated sutures
RCTs [24,25,29,45,46,50] comparing VICRYL Plus with VICRYL
showed significantly lower SSI risk with coated sutures (RR Four RCTs [23,29,46,51] reported data on wound dehiscence,
0.62, 95% CI 0.43e0.90, P ¼ 0.01). Pooled result of studies which were meta-analyzed using a random-effect model
[28,47,48,51] comparing two types of coated sutures versus the because of moderate heterogeneity (I2 ¼ 70%). Risk of wound
corresponding uncoated sutures suggested that the risk of SSI dehiscence was similar between coated and uncoated sutures
was similar between the two groups (RR 0.78, 95% CI 0.58e1.04, groups (RR 0.97, 95% CI 0.49e1.89, P ¼ 0.92; Fig. 4). Sensitivity
P ¼ 0.09). For RCTs [23,27,49] that studied PDS Plus versus PDS analysis showed that deleting each of the four data sets one by
Ⅱ, risk of SSI also did not decrease with coated sutures (RR 0.81, one did not significantly affect the pooled RR.
95% CI 0.59e1.13, P ¼ 0.22).
In analysis stratified by length of follow-up based on data 3.4. Treatment cost, length of hospital stay, operating
pooled across all types of surgery, the reduction of SSI risk time, and causative organism in patients treated with
with triclosan-coated sutures was significant regardless of triclosan-coated versus uncoated sutures
whether follow-up was longer than 30 d (RR 0.63, 95% CI
0.43e0.93, P ¼ 0.02) or shorter than 30 d (RR 0.79, 95% CI Subsets of the 13 RCTs compared the use of coated and
0.63e0.98, P ¼ 0.03). uncoated sutures in terms of treatment cost [27,45,50],
j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7 111

Fig. 3 e Forest plot of meta-analysis comparing the incidence of SSI in different subgroups of patients treated with triclosan-
coated or uncoated sutures. (Color version of figure is available online.)
112 j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7

Table 4 e Sensitivity analysis in subgroup with use of prophylactic antibiotic from studies included in the meta-analysis.
No. of studies Study removed No. of SSI, n/N Relative risk of P* I2 (%)
removed participants SSI (95% CI)
Coated Uncoated
sutures sutures

0 None 3769 211/1931 254/1838 0.79 (0.63e0.99) 0.04 29


1 Baracs et al. 2011 [27] 3384 188/1743 230/1641 0.76 (0.59e0.97) 0.03 35
1 Rasic et al. 2011 [46] 3585 207/1840 242/1745 0.83 (0.68e1.01) 0.06 18
1 Williams et al. 2011 [47] 3619 201/1856 240/1763 0.79 (0.62e1.01) 0.06 38
1 Seim et al. 2012 [25] 3446 195/1771 237/1675 0.77 (0.60e0.99) 0.04 38
1 Turtiainen et al. 2012 [28] 3493 180/1792 224/1701 0.75 (0.58e0.96) 0.02 31
1 Justinger et al. 2013 [49] 2913 180/1446 212/1467 0.86 (0.70e1.06) 0.16 10
1 Nakamura et al. 2013 [50] 3359 202/1725 235/1634 0.83 (0.67e1.03) 0.09 22
1 Diener et al. 2014 [23] 2584 124/1344 158/1240 0.74 (0.56e0.98) 0.03 30
*
Based on the Z test.

length of hospital stay [23,28,46,49,50], operating time patients with normal wound healing (15 versus 9), concurrent
[23,25,28,46,49e51], and causative organism [24,27,50,51] with different dressings in the two groups (32.7 units versus
(Tables 6 and 7). Three RCTs [27,45,50] concluded that 5.2 units). The study of Galal and El-Hindawy [45] docu-
triclosan-coated sutures might reduce treatment costs, mented that triclosan-coated sutures could save $1,517,727
owing to lower SSI incidence and shorter hospital stay yearly concerning 30,000 surgeries performed annually in
compared with uncoated sutures. More specifically, Baracs their hospital. And furthermore, Nakamura et al. [50] indi-
et al. [27] reported that SSI increased treatment costs, based cated that triclosan-coated sutures could save at least
on their findings that the average number of nursing days $42,444 concerning 410 patients in their study period. The
was significantly longer for SSI patients than that for mean length of hospital stay was similar between coated and

Table 5 e Data on antibiotic prophylaxis from studies included in the meta-analysis.


Study Antibiotic prophylaxis

Antibiotic used Drug usage, Drug usage,


intravenously or not time used

Deliaert et al. 2009 [29] Not received Not received Not received
Baracs et al. 2011 [27] Second-generation cephalosporin Received, unknown 30 min before incision
and metronidazole
Galal and El-Hindawy 2011 [45] Not reported Not reported Not reported
Rasic et al. 2011 [46] Gentamicin 160 mg and Intravenously During induction of anesthesia
metronidazole 500 mg
Williams et al. 2011 [47] Augmentin (amoxicillin Intravenously Received, unknown
clavulanate) 1 g
Zhang et al. 2011 [48] Not reported Not reported Not reported
Isik et al. 2012 [24] Not reported Not reported Not reported
Seim et al. 2012 [25] Cefalotine 2 g Intravenously Before skin incision, and
continued with 3-h intervals to
a total of 8 g
Turtiainen et al. 2012 [28] In three centers: Cefuroxime 3 g; Intravenously In three centers: within 1 h before
In two centers: Cefuroxime 1.5 g; the incision;
In one center: Vancomycin. In two centers: 1 h before incision
and then every 8 h for the first
24 h after the operation;
In one center: unknown.
Justinger et al. 2013 [49] Standard antibiotics: Received, unknown 60 min before the incision
Metronidazole and ceftriaxone;
in case of allergy:
Metronidazole and clindmycin.
Nakamura et al. 2013 [50] Cephalosporin Intravenously 30 min before incision and every
3 h of operative time; and after
operative time for 48 h
Thimour-Bergstrom et al. 2013 [51] Not received Not received Not received
Diener et al. 2014 [23] Received, unknown Received, unknown Before the incision
j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7 113

Fig. 4 e Forest plot of meta-analysis comparing the incidence of wound dehiscence in patient groups treated with triclosan-
coated or uncoated sutures. (Color version of figure is available online.)

uncoated sutures groups in five studies [23,28,46,49,50] SSI [52], and our results suggest that they are indeed effective
involving 2727 patients, although it was significantly longer in this regard.
by about 15 to 25 d in a study of 184 patients [46]. Use of In the current meta-analysis, the procedure-related factor
either type of suture was associated with similar operating of antimicrobial prophylaxis was analyzed for the first time in
time in all the studies [23,25,28,46,49e51] reporting data on the subgroup analysis, and the results favored group with use
that outcome. Four RCTs [24,27,50,51] suggested no much of prophylactic antibiotic in decreasing risk of SSI with coated
difference in causative organism for SSI between the two sutures. However, the results should be interpreted with
groups, and the most common organism differed in different caution because the result of subgroup with use of prophy-
types of surgery. lactic antibiotic was influenced by the study of Justinger et al.
[49], Rasic et al. [46], Williams et al. [47], and Nakamura et al.
[50]. Furthermore, number of studies without use of prophy-
3.5. Publication bias
lactic antibiotic was limited with only two RCTs. Furthermore,
more RCTs with high quality are needed to verify the inter-
The studies showed a symmetrical distribution in the funnel
action between the use of triclosan-coated sutures and pro-
plot, suggesting low risk of publication bias in our meta-
phylactic antibiotic in more detail in future studies.
analysis (Fig. 5).
We focused only on RCTs to ensure high-quality evidence,
and five of the 13 included trials with low risk of bias were
classified as high quality, whereas four trials with high risk of
4. Discussion bias were classified as low quality. The remaining four studies
had unclear risk of bias, suggesting moderate quality. The
This meta-analysis of 13 RCTs involving more than 5000 literature contains many more non-RCTs that examine the
patients shows strong evidence that triclosan-coated su- efficacy and safety of triclosan-coated sutures [26,53e61].
tures are associated with lower risk of SSI than conventional Nearly all such studies of which we are aware have come to
uncoated sutures when used in adult surgery. Subgroup similar conclusions as our meta-analysis about triclosan
analysis suggests that this risk reduction occurs at least in coating and risk of SSI in various types of surgery. On the other
abdominal surgery and may also apply in other types of hand, some studies, non-RCTs and RCTs alike, have found
surgery, but larger high-level RCTs for non-abdominal pro- similar risk of SSI between coated and uncoated sutures
cedures are needed to confirm this. Based on limited data of [22e28]. Nearly half of these studies [22,24e26,28,53,58,61]
four RCTs, which concerned only breast surgeries, abdom- focused on non-abdominal surgeries, where we failed to
inal surgeries, and cardiac surgeries, incidence of wound detect an association between coated sutures and reduced risk
dehiscence was similar for patients treated with either kind of SSI. Other such studies are subject to methodological prob-
of suture, suggesting that triclosan coating might not lems that complicate their analysis. For example, three studies
interfere with wound healing process. Limited evidence by Justinger et al. [56,57,62] involved a coated suture interven-
suggests that triclosan-coated sutures might also be asso- tion arm in which the type of coated suture was changed during
ciated with lower treatment costs in comparison with un- the course of the study, which may have affected the results.
coated sutures. Individual studies provide further insight into the antimi-
In addition to contamination of suture material, numerous crobial efficacy of triclosan-coated sutures. An in vitro study of
factors have been linked to the risk of SSI, including patient- Edmiston et al. [63] showed that coated sutures significantly
related factors such as age, gender, lifestyle, body mass reduced adherence by both gram-positive and gram-negative
index, pre-existing infection, diabetes, comorbidities, and bacteria, and that the low triclosan concentrations in com-
surgical history; and procedure-related factors such as type of mercial coated sutures were sufficient to inhibit bacterial
surgery, pre-surgical preparation (hair removal, skin prepa- colonization of the suture material. Studies in two animal
ration, and hand/forearm antisepsis), management of infec- models of SSI showed that VICRYL Plus sutures also reduced
ted or colonized surgical equipment, and antimicrobial concentrations of inflammatory mediators [20].
prophylaxis [1,2,6]. Triclosan-coated sutures with broad anti- Our meta-analysis found similar wound dehiscence rates
microbial activity were originally developed to reduce risk of among patients treated with triclosan-coated or uncoated
114 j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7

sutures, suggesting that triclosan might not interfere with

91.3  18.6

185.2  90.9
Uncoated

167.2  3.0
wound healing or generate significant complications. This is
sutures

152  80
137  68
230  88
185  54
Operating time*, min

NR
NR
NR

NR
NR
NR
consistent with a study in animals [16] showing that
triclosan-coated sutures had no side effects on surgical per-
formance. The clinical trials of Justinger et al. [62] and Zhuang
et al. [44] also showed that triclosan-coated sutures were
95.5  17.3

179.3  87.1
associated with lower risks of incisional disruption and

170.5  3.0
sutures

158  71
138  65
238  93
181  51
Coated

incisional hernia. Reviews have suggested that the triclosan


NR
NR
NR

NR
NR
NR
coating on sutures elicits minimal toxicity [14,64]. Whereas
larger high-level RCTs are needed to examine and verify this
issue in clinical surgeries, owing to the fact that only four
RCTs reported data on wound dehiscence and these four
Uncoated

15.6  10.4
Length of hospital stay*, d

sutures

21.4  2.8

5.2  4.3

12.5  6.3
studies only concerned breast surgeries, abdominal surgeries
15  13
NR
NR
NR

NR
NR
NR
NR

NR and cardiac surgeries.


Table 6 e Data on incidence of SSI, wound dehiscence and other secondary outcomes from studies included in the meta-analysis.

Few RCTs and non-RCTs [27,42,45,50,53,61,65,66] reporting


data on treatment costs in our meta-analysis and literature
found that the treatment costs for patients with infection
were much higher than that for patients without infection,
15.2  11.6
sutures

1.2  1.3

5.5  6.5

13.0  7.4
Coated

11  18

owing to longer hospital stay, and other factors. And


NR
NR
NR

NR
NR
NR
NR

NR

furthermore, although triclosan-coated sutures cost more


than conventional uncoated ones, the overall treatment costs
were much lower for patients using coated sutures based on
their calculation and comparison between triclosan-coated
and uncoated sutures owing to lower incidence of SSI with
Uncoated
Wound dehiscence, n/N

sutures

13/190
81/598

triclosan-coated sutures. However, the results should be


7/26

7/93
NR
NR

NR
NR
NR
NR
NR
NR
NR

explained with caution, considering that the number of


studies evaluating this issue was limited especially the num-
ber of RCTs, and these studies documented the similar result
that triclosan-coated sutures significantly reduced the inci-
sutures
Coated

dence of SSI. Therefore, further high-level RCTs are needed to


11/184
66/587
16/26

1/91
NR
NR

NR
NR
NR
NR
NR
NR
NR

evaluate the issue of treatment costs.


There also have been several meta-analyses [23,31,67e69]
evaluating the efficacy and safety of triclosan-coated sutures
previously. The study of Chang et al. [67] contained only seven
Uncoated
sutures

RCTs with small sample size and showed no advantage of


24/197
33/220

19/340
17/163
30/137
42/371
19/204
38/190
96/598
12/93
14/75
0/26

5/50

triclosan-coated sutures. The studies of Edmiston et al. [68]


SSI, n/N

and Daoud et al. [69] did not analyze in detailed aspects,


although they draw the same conclusion, which favored
triclosan-coated sutures. Although the study of Wang et al. [31]
sutures
Coated

23/188
17/230

16/160
31/139
31/485

23/184
87/587

involved large number of patients and evaluated the efficacy


10/75

9/170

9/206
0/26

4/91

2/51

of triclosan-coated sutures in more detailed aspects including


type of surgery, age and follow-up, the study contained non-
peer-reviewed RCTs and did not consider the role of antibi-
prophylaxis

otic prophylaxis. The recently published meta-analysis of


Not received

Not received
Antibiotic

Data are expressed as mean  standard deviation.

Diener et al. [23] contained only five RCTs without detailed


Received

Received
Received

Received
Received
Received
Received

Received

subgroup analysis. Our current meta-analysis with 13 RCTs


contained the newly published RCT of Diener et al. [23] which
NR

NR
NR

did not favor triclosan-coated sutures, and further we


analyzed in more detailed aspects, especially evaluated the
Thimour-Bergstrom et al. 2013 [51]

important factor of prophylactic antibiotic for the first time.


Galal and El-Hindawy 2011 [45]

Our meta-analysis provides strong evidence that


triclosan-coated sutures can reduce risk of SSI and might not
Turtiainen et al. 2012 [28]

Nakamura et al. 2013 [50]

interfere with wound healing process. The meta-analysis


Williams et al. 2011 [47]

Justinger et al. 2013 [49]


Deliaert et al. 2009 [29]

Diener et al. 2014 [23]


Baracs et al. 2011 [27]

Zhang et al. 2011 [48]

draws its strength from the large number of patients, the


Rasic et al. 2011 [46]

Seim et al. 2012 [25]

NR ¼ not reported.
Isik et al. 2012 [24]

diversity of medical centers from more than 12 developing


and developed countries, the range of surgery types, the high
quality of the study design and reporting and low heteroge-
neity in the data. Nevertheless further studies are needed to
Study

examine whether triclosan-coated sutures are effective at


*

preventing SSI in non-abdominal surgeries and to further


j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7 115

Table 7 e Data on causative organism for SSI from studies included in the meta-analysis.
Study Causative organism

Coated sutures Uncoated sutures

Baracs et al. 2011 [27] Pseudomonas aeruginosa Pseudomonas aeruginosa


Enterococcus faecium, Enterococcus faecium
E. coli, E. coli,
Enterococcus spp. Enterococcus spp.
S. epidermidis
Isik et al. 2012 [24] S. epidermidis S. epidermidis
Pseudomonas aeruginosa Staphylococcus aureus
Klebsielle pneumonaie Corynebacterium ssp
Candida albicans
Nakamura et al. 2013 [50] Bacteroides sp. Bacteroides sp.
Bacteroides fragilis Bacteroides fragilis
Enterococcus sp. Bacteroides ovatus
Enterobacter cloacae Bacteroides thetaiotaomicron
Enterococcus faecalis Enterococcus sp.
Staphylococcus aureus Enterobacter cloacae
Staphylococcus epidermidis Enterococcus faecalis
Peptostreptococcus magnus Enterococcus faecium
Pseudomonas aeruginosa
Methicillin-resistant Staphylococcus aureus
Thimour-Bergstrom et al. 2013 [51] Klebsiella Klebsiella
Enterococcus faecalis Enterococcus faecalis
Streptococcus mutans Streptococcus mutans
Staphylococcus aureus Staphylococcus aureus
Coagulase neg staphylococci Coagulase neg staphylococci
Pseudomonas aerginosa E. coli
Proteus mirabilis Serratia marcescens
Moraxella catarrhalis Citrobacter freundii

study the interaction of antibiotic prophylaxis with triclosan- Science and Technology Development Projects (14124003-4),
coated sutures. the Medical and Health Care Appropriate Technology
This meta-analysis is guided by the Preferred Reporting Research and Development Projects of Guangxi Province (nos.
Items for Systematic Reviews and Meta-Analyses statement S201417 and S201417-01), and the Innovation Project of
(Supplemental Table 1.doc). Guangxi Graduate Education (no. YCSZ2015113). The funders
had no role in study design, data collection and analysis, de-
cision to publish, or preparation of the article.
Authors’ contributions: J.G. and J.-H.Z. had full access to all
data in the study and take responsibility for their integrity and
Acknowledgment
the accuracy of the data analysis. J.G., J.-H.Z. and C.-Y.Z.
conceived and designed the study. J.G., L.-H.P., Y.-X.L., and J.-
This work was supported by funding from the National Nat-
H.Z. performed experiments. J.G., X.-D.Y., and L.-Q.L. acquired
ural Science Foundation of China (no. 81060173), the Guangxi
data. J.G., J.-H.Z., and C.-Y.Z. analyzed and interpreted data. J.-
H.Z., C.-Y.Z., L.-H.P., Y.-X.L., and L.-Q.L. provided administra-
tive, technical, or material support. J.G., J.-H.Z., L.-H.P., Y.-X.L.,
and X.-D.Y. wrote the article. J.G., J.-H.Z., C.-Y.Z., and L.-Q.L.
critically reviewed the article for important intellectual content.

Supplementary data

Supplementary data related to this article can be found at


http://dx.doi.org/10.1016/j.jss.2015.10.015.

Disclosure
Fig. 5 e Funnel plot for evaluating publication bias. RR,
relative risk; SE, standard error. (“Color version of figure is The authors report no proprietary or commercial interest in
available online.”) any product mentioned or concept discussed in this article.
116 j o u r n a l o f s u r g i c a l r e s e a r c h 2 0 1 ( 2 0 1 6 ) 1 0 5 e1 1 7

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