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Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-
Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs
Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical
Trial

Jaime Ruiz-Tovar, MD, PhD, Carolina Llavero, RN, Montiel Jimenez-Fuertes, MD,
PhD, Manuel Duran, MD, PhD, Mercedes Perez-Lopez, RN, Andres Garcia-Marin,
MD, PhD

PII: S1072-7515(20)30212-X
DOI: https://doi.org/10.1016/j.jamcollsurg.2020.02.031
Reference: ACS 9797

To appear in: Journal of the American College of Surgeons

Received Date: 10 July 2019

Revised Date: 25 November 2019
Accepted Date: 4 February 2020

Please cite this article as: Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M,
Garcia-Marin A, Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-
Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture
in Emergent Abdominal Surgery: A Randomized Clinical Trial, Journal of the American College of
Surgeons (2020), doi: https://doi.org/10.1016/j.jamcollsurg.2020.02.031.

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© 2020 Published by Elsevier Inc. on behalf of the American College of Surgeons.

Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-
Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs
Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical
Trial

Authors:
Jaime Ruiz-Tovar, MD, PhD1, Carolina Llavero, RN2, Montiel Jimenez-Fuertes, MD, PhD1,
Manuel Duran, MD, PhD1, Mercedes Perez-Lopez, RN3, Andres Garcia-Marin, MD, PhD4

1
Department of Surgery. University Hospital Rey Juan Carlos (Madrid - Spain)
2
Department of Surgery. University Hospital Sureste (Madrid - Spain)
3
Department of Surgery. University Hospital San Juan (Alicante - Spain)
4
Department of Surgery. Hospital de Hellin (Albacete - Spain)

Disclosure Information: Nothing to disclose.

Trial Registration: ClinicalTrials.gov, NCT03763279

Correspondence to:
Jaime Ruiz-Tovar, MD, PhD
Corazon de Maria, 64, 7 J
28002 – Madrid (Spain)
e-mail:jruiztovar@gmail.com
Tel: (0034)630534808

Short title: Sutures and Surgical Site Infection

1
Background: Triclosan-coated sutures have demonstrated to reduce surgical-site infections

(SSIs) in emergent surgeries of fecal peritonitis. Barbed sutures provoke a homogeneous

distribution of tension throughout the suture, implying better blood supply to the wound

edges and healing. The aim of this study was to evaluate the effect of using triclosan-coated

and barbed sutures for the fascial closure in patients undergoing emergent surgery, on SSI

and evisceration.

Study design: A prospective randomized clinical trial was performed. Patients were

randomized into 3 groups: those patients undergoing aponeurotic closure with Triclosan-

coated barbed suture (Stratafix SymmetricTM), patients undergoing closure with Triclosan-

coated Polydioxanone loop suture (PDS plusTM) and patients undergoing closure with

Polydioxanone loop suture (PDSTM). Primary investigated outcomes were SSI and

evisceration rates during a follow-up period of 30 days. Primary analysis plan was based on a

per-protocol approach.

Results: Incisional SSI was 6.4% (3 out of 47) in Stratafix SymmetricTM, 8.9%(4/45) in PDS

plusTM and 23.4% (11/47) in PDSTM (p=0.03). Evisceration rate was 0% in Stratafix

SymmetricTM, 8.9%(4/45) in PDS plusTM and 12.8%(6/47) in PDSTM(p=0.05). Median

hospital stay was 4 days(range 2-14) in Stratafix SymmetricTM, 5 days(range 2-21) in PDS

plusTM and 8 days (range 2-60) in PDSTM(p=0.012). The use of Triclosan-coated sutures

(Stratafix SymmetricTM and PDSplusTM) was associated with a lower risk of incisional

SSI(p=0.009), and the use of barbed suture was associated with a lower risk of

evisceration(p=0.019). Comparing Stratafix SymmetricTM with PDS plusTM, there were no

significant differences in SSIs, but evisceration rate was significantly higher in the PDS

plusTM group(p=0.036).

2
Conclusion: The use of triclosan-coated sutures (Stratafix SymmetricTM and PDSplusTM) in

emergent surgery reduces the incidence of incisional SSIs. The use of barbed sutures reduces

the incidence of evisceration.

Key words: Barbed suture; Triclosan-coated sutures; Surgical-site infection; Emergent

surgery

3
Introduction:

Surgical site infections (SSIs) are among the most common complications after dirty

abdominal surgery1,2. SSIs not only lead to a significant increase in morbidity, readmissions,

intensive care unit admissions and long-term surgical-site complications, but also results in a

greater risk of death in patients undergoing surgical procedures. Furthermore, SSIs challenge

healthcare systems by requiring additional hospital bed occupancy, escalated resource costs

and increased loss of working hours1-3.

A factor that may influence the incidence of SSIs is the suture used for closure of the

abdominal wall, since bacteria may adhere to the suture material4. Sutures can be coated with

antibacterial substances that may reduce the bacterial load in the wound. Triclosan (2,4,4-

trichloro-2-hydroxy-diphenylether) is an antiseptic substance that, in preclinical studies, has

been shown to reduce the growth of bacteria by inhibiting fatty acid synthesis5. Triclosan-

coated sutures have been analyzed in different surgical procedures in humans, though most of

them were conducted in clean and clean-contaminated ones. Among them, colorectal surgery

has been the most widely investigated procedure, as the high incisional SSI rates that present,

make these approaches as the most amenable to perform investigations on them6. However,

Triclosan-coated sutures have been shown to be efficacious in fecal peritonitis. Two previous

studies of our group evaluating the efficacy of Triclosan-coated sutures, concluded that the

use of these sutures might reduce the risk of incisional SSI7,8. Based on the scientific

evidence available, diverse organizations and societies have published recommendations,

supporting the use of Triclosan-coated sutures9.

Current evidence supports the use of absorbable monofilament sutures for abdominal fascial

closure, mainly based on the fact that braided sutures provide a better surface for the

adherence of microorganisms10. However, dirty surgery is associated with an increased rate

4
of evisceration, that can reach up to 15%8. A homogeneous distribution of tension throughout

the suture, as demonstrated with barbed sutures, is also important to avoid segmental

ischemia, tissue necrosis and secondary infection11. Up to our knowledge, there are no studies

analyzing the effect of using barbed sutured for the closure of the abdominal fascia after dirty

surgery. Moreover, the synergistic effect of the combination of barbed suture with the

Triclosan coat, should also be elucidated. Actually, manufacturers´ recommendations explain

that safety and efficacy of several barbed sutures (Stratafix Spiral PDOTM (Johnson &

JohnsonTM, USA), Stratafix Spiral PDSTM (Johnson & JohnsonTM, USA) and V-Loc 180TM

(MedtronicTM, USA) for abdominal fascial wall has not been established. However, this

warning has not been applied to Stratafix Symmetric PDS PlusTM (Johnson & JohnsonTM,

USA).

The aim of this study was to compare the use of triclosan-coated barbed suture, with non-

barbed Triclosan-coated suture and with non-barbed Triclosan-free suture in the closure of

abdominal fascia in patients undergoing emergent surgery, on incisional SSI and evisceration

rates (Primary endpoints), postoperative pain and analytical acute phase reactants (Secondary

endpoints).

Patients and methods:

A prospective, randomized multi-center study was performed between November 2018 and

March 2019. Inclusion criteria were patients undergoing emergent surgery by laparotomy and

mid-line approach, for community-acquired infections, peritoneal contamination secondary to

perforation of the digestive tract and ischemia of a segment of digestive tract requiring

resection. Exclusion criteria for enrollment into the study were patients with immune

deficiencies or intake of immunodepressive drugs and nosocomial infections. Patients with

5
post-enrollment events, such as patients undergoing reoperation, deceased or lost to follow-

up during the first 30 days postoperatively, and patients planned for a second-look surgery

were excluded for the final analysis.

Patients assessed for elegibility (meeting the inclusion criteria) signed the informed consent

form and then they were randomly assigned before beginning the surgical act, using a

random-number table, designed by the statistician before beginning the enrollment of

participants, into 3 groups: those patients undergoing fascial closure with triclosan-coated

Polydioxanone barbed suture caliber 1, 48mm cylindric needle (Stratafix SymmetricTM,

Johnson & JohnsonTM, USA), those undergoing fascial closure with triclosan-coated

Polydioxanone loop suture caliber 1, 48mm cylindric needle (PDS plus loopTM, Johnson &

JohnsonTM, USA) and those undergoing fascial closure with standard Polydioxanone loop

suture caliber 1, 48mm cylindric needle (PDS loopTM, Johnson & JohnsonTM, USA). The

surgeon knew the study assignment before beginning with abdominal wall closure. The

surgeon was masked to the assignment prior to consenting and enrolling the patient and

initiating the surgery. (CONSORT flow diagram-Figure 1).

The suturing technique in all the groups followed the 4:1 ratio (length of suture: length of

wound) with small bites of tissue (<1cm distance from the edge of the aponeurosis). After

fascial closure, subcutaneous tissue was irrigated with 100ml of normal saline. Subcutaneous

tissue was not sutured in any of the groups. The skin was closed with staples in all the

patients. During the surgery, the skin was prepared with clorhexidine-alcohol solution.

Perioperative systemic antibiotics (Imipenem 1g/8h iv) were employed in all the groups. In

case of allergies to Beta-lactams, Tygecycline (100 mg iv as start dosage, followed by 50

mg/12 h iv) was used. Both intravenous antibiotics were maintained at least during 5 days as

6
all the cases were considered as severe intra-abdominal infections. The decision of

prolonging the antibiotic treatment depended on the clinical evolution.

Definitions:

Incisional SSI was defined according the Centers for Disease Control (CDC) definitions of

SSI (an incisional SSI must have at least one of the following features: (i) purulent drainage;

(ii) positive culture; (iii) pain, tenderness, redness and swelling)12. In those patients diagnosed

of incisional SSI, incision was deliberately opened by a surgeon and a microbiological culture

was obtained in all the cases. Incisional SSI was evaluated during hospital stay and 30 days

after surgery in the Outpatient Clinic.

Evisceration was defined as the disruption of the fascial suture and presence of a viscera

outside the abdominal cavity. It can be covered by the skin or not. Any gap in the fascia was

considered as evisceration, independently of its size. Evisceration was an indication for

reoperation, but it was not considered an exclusion criterium for the analysis.

Follow-up:

All wounds were inspected by an epidemiology nurse, blinded to group allocation, daily

during the hospital stay and 30 days after surgery, once the patient has been discharged, and

evaluated according to the Centers for Disease Control (CDC) definitions of SSI, as

previously mentioned12. The epidemiology nurses participating in the study belonged to the

Preventive Medicine Department and were the staff responsible for evaluation and control of

community-acquired and nosocomial infections at the institutions.

7
The integrity of the bowel wall or presence of evisceration during the follow-up was

determined by a surgeon of the team, blinded to group allocation.

Variables:

The investigated clinical variables were age, gender, comorbidities, preoperative diagnosis

and surgical procedure, incisional SSI (including deep and superficial), evisceration,

mortality and duration of hospital stay. Microbiological cultures were obtained from the

opened wounds with incisional SSI. Postoperative pain was assessed 48 hours after surgery,

in those patients who were aware. Pain was measured by means of a Visual Analog Scale

(VAS), ranging from 0mm (absence of pain) to 100mm (unbearable pain). Analytical acute

phase reactants (C reactive protein, fibrinogen and lactate) and white blood cell count (WBC)

were also assessed 48 after surgery. Pain assessment and blood extraction was also performed

by the epidemiology nurse blinded to group allocation. 48 hours post-operatively was

selected as the time point for evaluation of pain and blood sample extraction, based on the

centers´ organization and availability of the epidemiology nurses.

Primary outcomes were incisional SSI and evisceration, during a follow-up period of 30 days.

Secondary outcomes included postoperative pain and analytical acute phase reactants,

determined 48 hours after surgery, and identification of microorganisms involved in the

incisional SSIs, when present.

Statistics:

8
Calculated sample size was assumed on an expected incisional SSI rate of 35% in the control

group (Polydioxanone monofilament non Triclosan-coated loop suture (PDS loopTM), based

on our previous publication8. With 80% beta and two-tailed alpha of 0.05, it was necessary to

include 43 patients in each experimental group (Triclosan-coated Polydioxanone loop suture

(PDS plus loopTM) and Triclosan-coated barbed Polydioxanone suture (Stratafix

SymmetricTM) to demonstrate a reduction if the true rate was 10% in incisional SSIs. The

number was increased by 7 patients in each study arm, in anticipation of lost at follow-up,

postoperative reoperations or mortality.

Statistical analysis was performed with the statistical software SPSS 22.0 for Windows.

Quantitative variables that followed an approximately normal distribution were summarized

by the mean and standard deviation. For non-Gaussian variables, the median and range were

used. Qualitative variables were summarized by number and percentage.

Comparison of variables between the 3 groups was performed with ANOVA test for

quantitative variables following a Gaussian distribution and Kruskal-Wallis was used for

non-Gaussian variables. Pairwise comparisons were performed with two-sample Student´s t-

test test and Mann-Whitney, when a non-Gaussian variable was included in the analysis.

Comparison of qualitative variables was performed with the Chi-square test. Two-sided P

values < 0.05 were regarded as significant.

Primary analysis plan was based on a per-protocol approach.

The study was approved by the Local Ethics Committee (HRJC-HUSJ 18-10). All the

patients signed a written informed consent for the surgical act and for the participation in the

randomized clinical trial before undergoing the emergent surgery.

Results:

9
A total of 150 patients were randomized, 50 in each group (Table 1). There were no

significant differences in mean age, sex, comorbidities or surgical procedure between groups

(Tables 1 and 2).

Reoperation rate was 4% (2 patients) in Stratafix SymmetricTM group, 6% (3 patients) in PDS

plusTM group and 4% (2 patients) in PDSTM group (p=0.30). The reason of relaparotomy was

the control of the septic focus in 5 cases and intra-abdominal bleeding in 2 cases. Mortality

rate was 2% in Stratafix SymmetricTM, 4% in PDS and 2% in PDS plusTM (p=0.51). The

cause of mortality was septic shock in all the patients.

After excluding the patients who deceased or required reoperation (postenrollment events),

finally 47 patients were included in Stratafix SymmetricTM group, 45 in PDS plusTM group

and 47 in PDSTM group for the analysis of investigated variables. There were no significant

differences in organ/space SSI among the 3 groups. The distribution of SSI rate, evisceration

rate and hospital stay stratified by groups is reported in Table 3. There were no significant

differences in SSI rates depending on the duration of the antibiotic treatment.

As secondary analyses, two study arms were grouped for pairwise analysis. The use of

Triclosan-coated sutures (grouping Stratafix SymmetricTM and PDS plus loopTM arms) was

associated with a lower risk of incisional SSI (p=0.009) (Table 4), and the use of barbed

suture (Stratafix SymmetricTM) was associated with a lower risk of evisceration when

compared with loop sutures (grouping PDS plusTM and PDSTM arms) (p=0.019) (Table 5).

A pairwise analysis, comparing Stratafix SymmetricTM group and PDS plus loopTM group,

detected no significant differences in the SSI rate between groups (p=0.650), but significantly

greater risk of evisceration in the PDS plus loop group TM (p=0.036)

Microbiological cultures of wound exudates in patients with incisional SSI:

10
The distribution of microorganisms in patients with incisional SSI among groups is described

in Table 6. It is remarkable that there is a low involvement of E. coli and there are no

isolations of Enterococcus faecalis among the patients undergoing fascial closure with

Triclosan-coated sutures.

Analytical acute phase reactants and postoperative pain:

Laboratory data (WBC count and acute-phase reactants) 48 hours after surgery and

postoperative pain, as measured by VAS 48 hours after surgery are presented in Table 7.

Significantly higher levels of postoperative pain and acute phase reactants, excepting lactate,

were observed among the patients of PDS loopTM group. When the patients presenting

postoperative complications were excluded from the analysis, neither significant differences

nor trends between groups were found (data not shown).

Discussion:

The results of the present study indicated that Triclosan-coated sutures reduce the risk of

incisional SSIs, whereas barbed sutures reduced the risk of postoperative evisceration, so the

use of Triclosan-coated barbed sutures is supported as the recommended method for fascial

closure in emergent open mid-line abdominal surgery.

Suture materials play an important role in the development of SSIs by providing a local

surface for the adherence of microorganisms. Once pathogens have colonized suture

materials, a biofilm may subsequently be formed to promote the attachment and reinforce the

resistance against the attack from the host´s immune system and antibiotic treatment, thus

predisposing to wound infection. Accordingly, the strategy of coating sutures with

11
antimicrobial agents to reduce the risk of suture-related SSIs has been considered. Triclosan

passively dissipates from implanted sutures to the surrounding tissues, creating a barrier

against bacterial colonization4,13.

In abdominal surgery, bacterial contamination comes from the digestive tract

(Enterobacteriacea and anaerobic microrganisms) and from the saprophytic flora of the skin

(grampositive). Sutures coated with antiseptic agents were designed to form a barrier against

the bacterial transit from the intraperitoneal cavity to the subcutaneous tissue, that might lead

to the development of incisional SSI. Moreover, their bactericide effect would prevent from

bacterial adhesion to the suture filaments. The most employed antiseptic agent used to coat

the sutures is Triclosan (2,4,4-trichloro-2-hydroxi-diphenileter). In preclinical studies,

Triclosan has demonstrated to reduce the bacterial load in the wound and to slow bacterial

growth, inhibiting the synthesis of bacterial fatty acids14,15.

Several meta-analyses have already been published, evaluating the efficacy of Triclosan-

coated sutures, demonstrating all of them a reduction in SSI rates, ranging from 24% to

84%6,16-24. Most of them report better results when applied to abdominal procedures, and

clean, clean-contaminated and contaminated procedures, whereas in dirty procedures the

beneficial obtained is more controversial. However, Leaper et al analyzed the clinical and

economic impact of the use of these sutures; despite the incisional SSI rate was lower with

the use of Triclosan-coated sutures in all procedures, the economical reduction was more

pronounced in contaminated and dirty procedures. A 39% SSI reduction was estimated

implying a mean sanitary cost reduction of 105€ per procedures among all types of surgeries,

with 65€ reduction in clean surgeries and 285€ in contaminated or dirty ones23. The reduction

in sanitary costs might be related with a reduction in hospital stay, as occurs in the present

study. In our series, all the patients developing SSIs presented longer hospital stay than the

12
median of their corresponding group, determining a longer median hospital stay in the PDS

loopTM group, as they present the highest SSI rate.

Referring to the type of suture used, diverse studies have shown that the beneficial effect of

Triclosan-coated sutures can be applied to all types. However, Henriksen et al revealed in the

TRISTAN review, meta-analysis and trial sequential analysis, a clear benefit of Triclosan-

coated Polyglactin sutures for abdominal wall closure, whereas, this benefit remains

uncertain when applied to Triclosan-coated Polydioxanone sutures25.

The actual evidence supports the use of Triclosan-coated sutures in abdominal surgeries.

Thus, several organizations and scientific societies, such as the World Health Organization

(WHO), the Centers for Disease Control and Prevention (CDC), the American College of

Surgeons (ACS) and the Surgical Infection Society (SIS), have included these sutures among

their recommendations to prevent SSIs9,22,26.

Antiseptic agents carry little risk of resistance as their rapid, direct and disruptive action is on

multiple, non-specific sites of microbial cell biology; unlike antibiotics which have slower

acting, more specific actions that risk mutation and spread of resistance through plasmid

transfer and other mechanisms. Moreover, it has been described that the Fabl gene encodes

the enoyl-acyl carrier protein reductase enzyme, which is essential in bacterial fatty acid

biosynthesis; triclosan is a Fabl inhibitor and therefore inhibits fatty acid biosynthesis27.

Altogether, these justify that Triclosan can reduce 90% to 99.9% the inoculates of

Escherichia coli and Staphylococcus aureus28. These data are confirmed in our patients,

presenting reduction in the involvement of E. coli in the incisional SSI in the Triclosan-

coated sutures groups. It is remarkable that in the Triclosan-coated Groups there were no

infection caused or with participation of Enterococcus faecalis, while in the PDS loopTM

group this microorganism was involved in 40% of the SSIs. In our previous study, evaluating

13
the effect of Triclosan on Polyglactin sutures in fecal peritonitis surgeries, similar results

were obtained, with a significant reduction in E.coli and absence of Enterococcus faecalis

involvement, in the Triclosan-coated group7. Triclosan has been shown to be very effective

against Gram-positive bacteria; though most studies have evaluated only S. aureus, the

bacterostatic efficacy of triclosan can be extrapolated to Enterococcus faecalis and even to

Streptococcus spp, which also present higher rates of involvement in those patients with

incisional SSIs from the PDS loopTM group15.

The results of the present study also describe greater postoperative pain and higher levels of

acute phase reactants and WBC in the PDS loopTM group. However, when removing those

patients presenting postoperative complications from the analysis, significant differences in

postoperative pain or acute-phase reactants could not be observed. This reflects that the

higher levels of pain and laboratory data mostly reflect the septic status. The patients from the

Stratafix SymmetricTM group showed slightly lower pain and analytical levels, but without

reaching statistical significance. The present study has an insufficient sample size to

determine significant differences on these variables, but further studies should be conducted

to evaluate if the barbed suture might have a certain effect on reducing postoperative pain or

acute phase reactants. Moreover, it should be also evaluated if Triclosan-coated sutures have

also a certain immunomodulating effect on inflammatory response, independently of the

effect on reduction of SSIs.

There is growing evidence regarding the safety and efficacy of barbed sutures or Knotless

Tissue Control Devices in general and minimally invasive gynecological procedures. Barbed

sutures allow consistent tension control over the suture line and avoid the need for knots.

These devices are effective for reducing procedural time, achieving superior hemostasis and

comparable wound approximation to traditional sutures11. The barbed suture works as an

internal stitching element which is positioned by insertion into opposite walls of the incision

14
below the external surface of the tissue involved. The barbs on the ends of the suture are

designed and adapted to snag or penetrate into the surrounding tissue and thereby prevent

slippage off the suture29. Despite the fact that at first sight the pressure distribution in

conventional sutures is similar throughout the suture line, there is a tension increasement in

the knot and its closest suture area. This tension gradient may interfere with a homogeneous

healing of the wound edges. Moreover, the suture area close to the knot, presents up to 95 %

reduction in strength30,31. This could be explained by the slipping effects of the suture

material itself through the knot and the inevitable elongation suffered in the knotting process.

A too tight knot is sometimes performed in order to counteract this slipping effect, impairing

a correct blood supply to this region, which could cause necrosis and/or insufficient wound

healing32. This fact is even more important in dirty surgeries and with a systemic infection,

when the wound healing process is impaired.

Experimentally, it was found that the strength applied for dehiscence was higher in the

barbed suture compared to the non-barbed suture. This is probably caused by the

homogenoeus distribution of the strength along all the suture, allowing a better perfusion of

the edges of the wound and favouring a correct healing33,34.

Moreover, from a technical point of view, the self-locking system of the barbed suture,

allows that if there is a tearing of the tissue at one point of the wound, the rest of the wound

remains unaltered with both edges closed, making more difficult a complete dehiscence.

Altogether, these are posible reasons that might justify that the evisceration rate was

signifincatly lower in the group with barbed suture closure. In fact, there were no cases of

eviseration among these patients.

Limitations:

15
The powering of this study has been calculated on an expected SSI rate of 35% in the control

group. This date was obtained from a previous muti-center retrospective study. However, the

SSI rate of the control group in the present study was only 23%. We must assume that in a

randomized clinical trial most confusing factors are controlled, whereas in retrospective

studies diverse confusing factors cannot be considered, leading to increased SSI rates. This

suboptimal estimation of the SSIs rate in the control group for the sample size calculation,

might have led to a a certain underpower of the study.

In this study we performed a “per protocol” analysis. It is widely accepted that “intention-to-

treat” analyses are more adequate for randomized clinical trials. However, in the original

design of the present study we considered that deceased patients or those ones who will

undergo reoperations might mask the results obtained. Future studies must be designed for an

“intention-to-treat” analysis to confirm our results.

In the present study, PDSTM and PDS PlusTM groups had looped sutures, whereas Stratafix

SymmetricTM suture was single stranded suture. Thus, the amount of foreign material was

theoretically half in the Stratafix group. Notwithstanding, the increased amount of foreign

material did not affect the SSI rate in the PDS plusTM group when compared with Stratafix

SymmetricTM one.

The Stratafix SymmetricTM suture included in the study has a Triclosan coat. It would have

been ideal to include a fourth arm of study with a Triclosan-free barbed suture. However,

there is no Triclosan-free Stratafix SymmetricTM polydioxanone suture commercially

available. Moreover, manufacturers´ warning about lack of evidence of safety and efficacy of

barbed sutures for abdominal fascial wall closure has not been applied only to Stratafix

SymmetricTM polydioxanone and Triclosan-coated (Johnson & JohnsonTM, USA). There are

16
other commercially available barbed sutures (V-LocTM, MedtronicTM, USA), though they

may not be appropriate for fascial closure.

Finally, we constructed aggregation variables, such as Triclosan-coated sutures (including

Stratafix SymmetricTM and PDS plus loopTM) and Polydioxanone loop sutures (including

PDS loopTM and PDS plus loopTM) and performed pairwise analysis for SSI and evisceration

rates evaluation. The design of this study was not powered for the development of these

aggregation variables. Thus, future studies must be conducted to confirm our results.

Conclusion:

The use of triclosan-coated sutures in emergent surgery reduced the incidence of incisional

SSIs, postoperative pain and analytical acute phase reactants. The use of barbed sutures

reduced the incidence of evisceration. Triclosan-coated barbed sutures can be considered as

recommended sutures for aponeurotic closure in emergent mid-line approaches.

17
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 Table 1: Distribution of Patient Demographic and Clinical Characteristics at Baseline,
Stratified by Study Arm, as Randomized

Baseline characteristic Stratafix PDS plus PDS loop p Value Two

Symmetric loop -
side
Sex, m/f 28/22 26/24 25/25 0.83 d p
valu
Age, y, mean ± SD 65.8 ± 16.9 64.7 ± 15.9 63.2 ± 17.8 0.78 es
Hypertension, n (%) 22 (44) 24 (48) 25 (50) 0.83 are
for
Diabetes mellitus, n (%) 11 (22) 12 (24) 9 (18) 0.76 the
over
Dyslipidemia, n (%) 20 (40) 17 (34) 15 (30) 0.57 all
Cardiopathy, n (%) 7 (14) 9 (18) 7 (14) 0.81 3-
grou
COPD, n (%) 3 (6) 2 (4) 2 (4) 0.88 p
com
parison. N=50 patients in each group.

23
Table 2: Distribution of Surgical Techniques among Randomized Patients, Stratified by
Study Arm

Surgical technique Stratafix PDS plus PDS loop p Value

Symmetric loop
n % n % n %
Bowel obstruction requiring 15 30 15 30 15 30 >0.99
bowel resection, n (%)
Fecal peritonitis secondary to 15 30 15 30 15 30 >0.99
perforated diverticulitis (%)
Fecal peritonitis secondary to 10 20 10 20 10 20 >0.99
perforated neoplasm (%)
Acute bowel ischemia (%) 10 20 10 20 10 20 >0.99
Two-sided p values are for the overall 3-group comparison. N=50 patients in each group.

24
Table 3: Distribution of Surgical Site Infection, Evisceration and Duration of Hospital Stay,
Stratified by Study Arm.
Variable Stratafix PDS plus loop PDS loop p Value
Symmetric (n = 45) (n = 47)
(n = 47)
Organ/space SSI, n (%) 2 (4.3) 1 (2.2) 2 (4.3) 0.83
Incisional SSI, n (%) 3 (6.4) 4 (8.9) 11 (23.4) 0.03
Day of SSI diagnosis*, 5 (5-6) 5 (4-6) 4.5 (3-8) 0.86
median (range)
Evisceration, n (%) 0 (0) 4 (8.9) 6 (12.8) 0.05
Evisceration gap size, - 6 (4-12) 6.5 (5-12) 0.796
cm, median (range)
Duration of hospital 4 (2-14) 5 (2-21) 8 (2-60) 0.012
stay, d, median (range)
Patients with post-enrollment events were excluded from the analysis. P values are for the
overall 3-group comparison.
*Number of days from completion of surgery until SSI diagnosis, calculated only for patients
who developed SSI.
SSI, surgical site infection.

25
Table 4: Distribution of Surgical Site Infection, Evisceration, and Hospital Stay Depending
on the Use of Triclosan-Coated Sutures or PDS Loop
Variable Triclosan-coated PDS loop p Value
sutures* (n = 47)
(n = 92)
Organ/space SSI, n (%) 3 (3.3) 2 (4.3) 0.77
Incisional SSI, n (%) 7 (7.6) 11 (23.4) 0.009
Evisceration, n (%) 4 (4.3) 6 (12.8) 0.07
Hospital stay, d, median 4 (2-21) 8 (2-60) 0.006
(range)
P values are not adjusted for multiple comparisons
*Including Stratafix Symmetric and PDS plus loop arms
SSI, surgical site infection

26
Table 5: Distribution of Surgical Site Infection, Evisceration and Hospital Stay Depending
on the Use of Barbed Sutures or Loop Sutures
Variable Stratafix Polydioxanone p Value
Symmetric loop sutures*
(n = 47) (n = 92)
Organ/space SSI, n (%) 2 (4.3) 3 (3.3) 0.77
Incisional SSI, n (%) 3 (6.4) 15 (16.3) 0.10
Evisceration, n (%) 0 (0) 10 (10.9) 0.019
Hospital stay, d, median 4 (2-14) 6 (2-60) 0.32
(range)
P values are not adjusted for multiple comparisons.
*Including PDS plus loopTM and PDS loopTM arms.
SSI, surgical site infection.

27
Table 6: Microbiological Cultures of Wound Exudates in Patients with Incisional Surgical
Site Infection

Microorganism Stratafix PDS plus PDS loop

Symmetric loop (n = 11)
(n = 3) (n = 4)
E coli 1 (33.3) 1 (25) 9 (81.8)
Klebsiella spp 1 (33.3) 2 (50) 4 (36.4)
Streptococcus spp 1 (33.3) 1 (25) 5 (45.5)
E faecalis 0 (0) 0 (0) 4 (36.4)

28
Table 7: Secondary Outcomes: Distribution of Perioperative Factors (White Blood Cell
Count, Analytical Acute Phase Reactants, and Postoperative Pain), Stratified by Study Arm,
Quantified 48 Hours after Operation.

Perioperative Stratafix PDS plus loop PDS loop p Value

factor Symmetric (n = 45) (n = 47)
(n = 47)
White blood 11548 ± 5432 11859.1 ± 5987.3 13626.7 ± 6845.8 0.016
cell count,
WBC/mm3
C-reactive 17.2 ± 9.8 19.6 ± 10.1 27.4 ± 12.6 0.009
protein, mg/dL
Fibrinogen, 466.5 ± 121.9 498.2 ± 117.8 587.5 ± 126.3 0.032
mg/dL
Lactate, mg/dL 1.6 ± 1.6 1.6 ± 1.4 1.7 ± 1.6 0.37
Pain, mm 29.2 ± 9.5 33.6 ± 10.2 48.7 ± 11.1 0.044
Data presented as mean ± SD. Pain was assessed by Visual Analog Scale (range 0 = no pain –
100 = unbearable pain). Patients with post-enrollment events were excluded from the
analysis.

29
Figure 1. CONSORT flow diagram.

30
Precis:

The use of triclosan-coated sutures in emergency surgery reduces the incidence of incisional

surgical site infection. The use of barbed sutures reduces the incidence of evisceration.

31