Triclosan in Single Use Medical Devices for Preventing Infections: A Review of Clinical Effectiveness, Safety and Guidelines

Kendra Brett; Charlene Argáez

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Triclosan in Single Use Medical Devices for Preventing Infections: A Review of Clinical Effectiveness, Safety and Guidelines

CADTH Rapid Response Report: Summary with Critical Appraisal

Kendra Brett and Charlene Argáez.

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jul 11.

Abbreviations

AGREE II: Appraisal of Guidelines for Research & Evaluation 2
AMSTAR 2: A Measurement Tool to Assess systematic Reviews
CDC: Centers for Disease Control and Prevention
GRADE: Grading of Recommendations, Assessment, Development, and Evaluation
HTA: health technology assessment
NICE: National Institute for Health and Care Excellence
NRS: non-randomized study
PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
RCT: randomized controlled trial
SR: systematic review
SSI: surgical site infection
WHO: World Health Organization

Context and Policy Issues

Health care associated infections are preventable infections that pose a substantial risk to patient safety and burden to the health care system.¹ In Canada, more than 200,000 patients a year acquire health care associated infections while receiving care in Canada, and more than 8,000 of these patients die as a result.² According to the World Health Organization (WHO), surgical site infections (SSIs) are one of the most common health care associated infections.³ There are many factors that contribute to the development of health care associated infections, and preventing infections in health care setting is multi-factorial. For SSIs, preventative steps must be taken before, during, and after surgery.³

Triclosan is a synthetic antimicrobial compound. At low concentrations, triclosan suppresses the growth of numerous bacteria, and at higher concentrations, it can rapidly kill bacteria⁴. Due to its antiseptic and disinfectant properties, triclosan is used in numerous products, including personal care products (e.g., hand soap), household items (e.g., cutting boards), and medical devices (e.g. sutures, catheters).⁴ Wider use of antiseptics and antimicrobials has been suggested for surgical practice,⁵ however, it is unclear whether using triclosan on single use medical devices or consumables (e.g., sutures) is likely to provide a significant benefit in reducing infections in hospitalized patients.

The purpose of this report is to synthesize and critically appraise the available evidence on the clinical effectiveness and safety of using triclosan on single use medical devices or consumables for infection prevention in hospitalized patients. Additionally, evidence-based guidelines regarding the use of triclosan on medical devices or consumables for infection prevention will be reviewed. This information may be used to inform decision making relating to health policy of the use of triclosan on single use medical devices or consumables.

Research Questions

What is the clinical effectiveness and safety of using triclosan on single use medical devices and/or consumables for infection prevention in hospitalized patients?
What are the evidence-based guidelines regarding the use of triclosan in medical devices and/or consumables?

Key Findings

One health technology assessment, one systematic review, six randomized controlled trials, and one non-randomized study were identified regarding the clinical effectiveness of triclosan on single use medical devices or consumables. All the relevant evidence examined triclosan-coated sutures compared to uncoated sutures. The evidence mostly consisted of low to moderate quality studies in adult patients, with one high quality study conducted in pediatric patients. There was evidence from one low-quality systematic review, as well as low-, moderate-, and high-quality randomized controlled trials that triclosan-coated sutures were associated with a lower risk of surgical site infections in hospitalized patients compared with patients treated with uncoated sutures.

There was limited evidence of variable quality to suggest that triclosan-coated sutures were associated with reduced risk of wound dehiscence, a lower use of antimicrobials post-operatively, fewer instances of wound revision, fewer outpatient visits, lower readmission rate, lower surface temperature, and fewer instances of evisceration.

Limited evidence of variable quality also suggested that triclosan-coated sutures made no difference compared to uncoated sutures with regards to quality of life, the incidence of incisional hernia. post-operative mortality, critical care admission, clostridium difficile infections, pain, functional score, and complications.

Three evidence-based guidelines were identified. All three guidelines suggest considering the use of triclosan-coated sutures for the prevention of surgical site infections.

Overall, patients treated with triclosan-coated sutures had outcomes that were better or not different than patients treated with uncoated sutures.

Methods

Literature Search Methods

A limited literature search was conducted by an information specialist on key resources including PubMed, the Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were triclosan and medical devices or surgical supplies. Search filters were applied to limit retrieval to health technology assessments (HTAs), systematic reviews (SRs), meta-analyses, randomized controlled trials, non-randomized studies, and guidelines. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2014 and June 12, 2019.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Table 1

Selection Criteria.

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published prior to 2014. Primary studies that were captured in an included SR, meta-analysis, or HTA were excluded. SRs with full overlap (i.e., the included studies that meet the selection criteria for this report are fully captured in another more recent or more comprehensive SR) were excluded. Guidelines with unclear methodology were also excluded.

Critical Appraisal of Individual Studies

One reviewer critically appraised the included studies. The HTA and SR were appraised using AMSTAR 2,⁶ the randomized and non-randomized studies were critically appraised using the Downs and Black checklist,⁷ and the guidelines were assessed with the AGREE II instrument.⁸ Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included study were described narratively.

Summary of Evidence

Quantity of Research Available

A total of 289 citations were identified in the literature search. Following screening of titles and abstracts, 258 citations were excluded and 31 potentially relevant reports from the electronic search were retrieved for full-text review. Four potentially relevant publications were retrieved from the grey literature search for full text review. Of these potentially relevant articles, 23 publications were excluded for various reasons, and 12 publications met the inclusion criteria and were included in this report. These comprised one HTA, one SR, six RCTs, one non-randomized study, and three evidence-based guidelines. Appendix 1 presents the PRISMA⁹ flowchart of the study selection. Of the 22 reports excluded, there were nine SRs¹⁰^–¹⁸ that met the inclusion criteria for this report but were excluded for having overlapping primary studies with the more comprehensive publications included in this report. Appendix 5 outlines the degree of overlap between the included and excluded SRs, and Appendix 6 provides the list of excluded SRs.

Summary of Study Characteristics

One HTA,¹⁹ one SR and meta-analysis,²⁰ six RCTs,²¹^–²⁶ one non-randomized study (NRS),²⁷ and three evidence-based guidelines were identified and included in this review. Detailed characteristics are available in, Table 2, Table 3, and Table 4.

Study Design

One HTA¹⁹ and one SR and meta-analysis²⁰ were identified, both of which were published in 2017. The HTA aimed to evaluate the safety and effectiveness of antibacterial-coated sutures (including triclosan-coated sutures) for the prevention of SSIs in abdominal surgery in adults.¹⁹ The SR and meta-analysis aimed to study the effectiveness of triclosan-coated sutures in the prevention of SSIs in any surgical procedure (excluding dental surgeries).²⁰ The reviews included literature published prior to October 2016 for the HTA,¹⁹ and July 2016 for the SR (search start dates were not reported in either publication).²⁰ Both publications included RCTs and NRSs. The HTA¹⁹ used findings from RCTs to examine the effectiveness of triclosan-coated sutures, and findings from RCTs and NRS to examine safety, whereas the SR²⁰ used both RCTs and NRS to examine effectiveness. Of the nine studies included in the HTA, seven of the studies overlap with the primary studies included in the SR; the degree of overlap is summarized in Appendix 5.

This report includes six RCTs²¹^–²⁶ published in 2017 or 2018, which included between 102 and 2,546 patients. Five RCTs²¹^–²⁵ were single-centre studies which randomized individual patients to the intervention or control sutures, and one RCT²⁶ was a multi-centre study that randomized each centre on a monthly basis to either the intervention or control sutures. One multi-center NRS was identified;²⁷ it was published in 2018, was a retrospective cohort, and included 104 patients.

Three relevant evidence-based guidelines were identified.²⁸^–³⁰ These guidelines were published in 2019 by the National Institute for Health and Care Excellence (NICE),²⁹ in 2017 by the Centers for Disease Control and Prevention (CDC)²⁸, and in 2016 by the WHO.³⁰ All three guidelines used systematic searches of various electronic databases to identify evidence; the guidelines developed by NICE²⁹ and the CDC²⁸ included SRs and RCTs, while the guideline developed by the WHO³⁰ included RCTs and NRSs. All three guidelines used a variation of GRADE to evaluate the certainty of the evidence and the strength of the recommendations.

Country of Origin

The HTA was led by authors in Croatia,¹⁹ and the SR was led by authors in Greece.²⁰ The RCTs were conducted in Turkey,²¹^,²⁴ Japan,²² Taiwan,²³ United Kingdom,²⁶ and Finland.²⁵ The NRS was conducted in Spain.²⁷ The guidelines are meant to apply to the United Kingdom,²⁹ the United States,²⁸ and globally.³⁰

Patient Population

The HTA included adult patients with elective or emergency open or minimally invasive abdominal surgery.¹⁹ The SR included patients with non-dental surgery requiring sutures, and did not restrict eligibility by patient age.²⁰

Five RCTs²¹^–²⁴^,²⁶ and the NRS²⁷ included adult patients, and one RCT included children (<18 years).²⁵ The type of surgeries used in the primary studies included primary closure for pilonidal disease,²¹ gastroenterological,²² total hip or knee arthroplasty,²³^,²⁶ general or orthopedic,²⁵ and fecal peritonitis.²⁷ All patients in the primary studies were from hospitals.

The target population of the three guidelines are patients who require surgical wound closure.²⁸^–³⁰ The intended users of the NICE guideline are healthcare professionals, patients and their families;²⁹ the intended users of the WHO guidelines are healthcare professionals, policy makers, and infection control professionals;³⁰ the CDC guideline did not report their intended users.²⁸

Interventions and Comparators

All the included publications examined triclosan-coated sutures. No other triclosan-coated devices and/or consumables were examined in the eligible publications. The HTA examined the following triclosan-coated surgical sutures (i.e., polyglactin 910 - Vicryl Plus, polyglecaprone - Monocryl Plus, and polydioxanone - PDS Plus), compared to an uncoated equivalent standard suture (i.e. Vicryl, Monocryl, PDS II).¹⁹ The SR included any type of triclosan-coated or uncoated sutures.²⁰

One RCT examined triclosan-coated versus uncoated monofilament polydioxanone 1/0 sutures (i.e., PDS).²⁴ Two RCTs examined triclosan-coated versus uncoated polyglactin sutures (i.e., Vicryl).²³^,²⁶ Two RCTs²¹ included coated and uncoated Vicryl and PDS sutures, as different tissue layers were closed with the different suture materials. One RCT included three types of triclosan-coated and uncoated sutures (i.e., polyglactin 910, poliglecaprone 25, or polydioxanone), as different suture materials were necessary for the various pull-out strengths and resorption times of the different types of surgery included in the study.²⁵ The NRS included triclosan-coated and uncoated Vicryl and PDS sutures.²⁷

Outcomes

All included studies examined SSIs.¹⁹^–²⁷ In seven of the studies, the follow-up duration for SSIs was 30 days post-operatively.¹⁹^,²¹^,²²^,²⁴^–²⁷ In the other RCT, the follow-up duration for SSIs was three months post-operatively, and the SR included primary studies with follow-up ranging from two weeks to 12 months.²⁰ Five of the studies¹⁹^,²²^,²⁵^–²⁷ used the CDC definition of SSIs,³¹ and four of these studies examined superficial and deep SSIs.¹⁹^,²²^,²⁵^,²⁶ The other four studies did not provide a specific definition of SSI.²⁰^,²¹^,²³^,²⁴

Additional outcomes that were reported by more than one publication include mortality,¹⁹^,²⁰^,²⁶^,²⁷ length of hospital stay,¹⁹^,²⁴^,²⁶^,²⁷ and wound dehiscence.¹⁹^–²¹^,²⁵ The following outcomes were reported in one of the studies included in this review: number of extra visits to a nurse or physician,²⁵ wound revision,²⁵ antimicrobial use,²⁵ readmission,²⁵ evisceration (disruption of the fascial suture and presence of viscera outside of the abdominal cavity),²⁷ Clostridium difficile infections,²⁶ critical care admission,²⁶ pain level,²³ functional scores,²³ wound condition,²³ quality of life,¹⁹ revision surgery for wound complications,¹⁹ and adverse events (any or serious adverse events).¹⁹^,²⁶

The outcome of interest to the guidelines was the prevention of SSIs.²⁸^–³⁰

Summary of Critical Appraisal

Additional details regarding the strengths and limitations of included publications are provided in Appendix 3, Table 5, Table 6, and Table 7.

Systematic Reviews and Meta-Analyses

The AMSTAR 2 assessment of the HTA¹⁹ and the SR²⁰ found that both reviews had well described research questions and eligibility criteria. Neither review made specific reference to a written protocol, though the HTA referenced methodological guidance documents from their HTA agency suggesting more rigorous methods were used.¹⁹ Both reviews included RCTs and NRSs, however, the SR²⁰ may have inappropriately combined both study types in some of their meta-analyses (resulting in moderately to high statistical heterogeneity), while the HTA¹⁹ used the findings from the NRS to inform the harms questions and not the effectiveness questions, which is the recommended approach for SRs and meta-analyses.⁶ Nonetheless, the SR²⁰ did conduct sensitivity analyses of their findings in which RCTs and NRS were analyzed separately to reduce the heterogeneity from the different study designs (resulting in reduced statistical heterogeneity). There is also some concern about the clinical heterogeneity in the SR,²⁰ as the results were pooled from multiple different types of surgical procedures, rather than studying similar populations and procedures.

The HTA¹⁹ used a comprehensive literature search strategy. The search strategy used in the SR²⁰ did not meet the AMSTAR 2 criteria for a comprehensive search strategy. Nevertheless, compared to the other SRs that this report examined for overlapping primary studies (Appendix 5), this included SR²⁰ contained the most comprehensive list of RCTs and NRS examining triclosan-coated sutures for the prevention of SSIs, suggesting that the search strategy was comprehensive. Both reviews performed their study selection in duplicate. The HTA¹⁹ performed data extraction in duplicate, but the SR²⁰ did not report how many people conducted the data extraction. Both reviews reported sufficient detail about the included primary studies, including the funding sources.

Both reviews assessed the risk of bias of the included RCTs using tools that assessed blinding and allocation; the HTA¹⁹ used the Cochrane Risk of Bias Tool, and the SR²⁰ used the Jadad criteria. Risk of bias of the NRSs was assessed using the Newcastle-Ottawa Scale in the SR,²⁰ whereas the HTA¹⁹ assumed that the NRSs were low quality by design (and did not assess risk of bias in the NRSs). Both reviews considered the impact of the risk of bias of the RCTs by conducting separate meta-analyses based on whether the studies were of high or low risk of bias. The SR²⁰ focused their conclusions on the evidence from higher quality studies.

Randomized Controlled Trials

The quality of the reporting was generally well done for all of the RCTs. The six RCTs²¹^–²⁶l had clear descriptions of their objectives, patient eligibility criteria, interventions and controls. The outcomes were well described and well reported in five RCTs.²¹^,²²^,²⁴^–²⁶ The outcome reporting was not well done in one RCT²³ (i.e., insufficient descriptions of the outcomes, selectively reported outcomes, failing to report simple outcome data), which may affect the interpretation of the results. Adverse events were not reported in four RCTs,²¹^–²⁴ while two RCTs²⁵^,²⁶ reported adverse events. All the RCTs had minimal or no loss to follow-up and reported actual probability values (and confidence intervals, where appropriate).

Patients were described as blinded to the intervention in four RCTs,²²^,²³^,²⁵^,²⁶ and this was not described in the other two RCTs,²¹^,²⁴ however, it is unlikely that patients could have identified whether they received triclosan-coated or uncoated sutures, nor it is likely that this would have influenced the incidence of SSIs. All six RCTs reported that the investigator assessing the outcomes (e.g., SSIs) was blinded to the intervention. The randomization and allocation process was thoroughly described in one RCT,²⁵ and well described in another RCT.²³ Two RCTs²¹^,²⁴ provided insufficient details of their randomization and allocation process. One RCT²² randomized their patients in blocks of two, which may have introduced bias into the randomization process. The other RCT²⁶ used a quasi-randomized approach whereby treatment centres were randomized to the intervention monthly, which has the potential to bias patient selection. The authors of this RCT suggest that this pragmatic approach to randomization would not have biased the study, as patients are placed on the waiting list three months prior to surgery, and therefore the study intervention would not be known prior to scheduling the surgery.²⁶ However, there is the potential that this quasi-randomization approach could have influenced selection bias, as it is possible that surgery dates may be moved for numerous reasons, such as cancellations or available resources.

Statistical tests to compare the main outcome were appropriate in the RCTs. One RCT²⁴ failed to adjust for confounding factors in their analysis, despite numerous significant differences in baseline characteristics of the treatment groups that could have influenced the outcome (e.g., smoking status, target organ, emergency surgery). Four RCTs²²^,²⁴^–²⁶ had a sufficient sample size, and it could not be determined if the other two RCTs²¹^,²³ were sufficiently powered.

Study participants, care providers, and health care settings in all six RCTs appear to be representative of the people and facilities that would be expected in a clinical context, increasing the external validity of the body of evidence. Finally, the authors of three RCTs²¹^,²²^,²⁶ failed to disclose conflicts of interest or the sources of funding for the study.

Non-Randomized Study

The reporting of the NRS was moderately well done.²⁷ The study had clear descriptions of its objective, intervention, control, and outcomes, but did not report the distribution of potential confounders between the groups, nor did it report simple outcome data thus reducing the ability to double check the major analyses. Adverse events were not reported, and actual probability values were only reported if the finding was significant (otherwise it was reported as ‘not significant’). Given the retrospective design of this study, the patients, care providers, and health care settings are representative of how patients would be treated in the “real-world”. Also, by design, the patients and outcome assessors were not blinded to the treatment, however, due to the retrospective nature of the study it is unlikely that this could have influenced the findings. Due to the non-randomized design, it is unknown what criteria were used to determine which patients were treated with triclosan-coated sutures versus uncoated sutures, and whether this could influence the outcomes. It is unclear whether the risk ratio for the main finding was calculated correctly, as it was not possible to re-calculate the same risk ratio based on the outcome data that was reported, and it is uncertain whether the authors have accurately interpreted these results, resulting in substantial uncertainty in the findings.

Guidelines

All three guidelines were high quality and had few weaknesses. The scope and purpose of each set of guidelines were clear. The authors described their objectives, health questions, and populations to whom the guidelines were relevant. Each guideline development group took steps to ensure that stakeholders participated in the process: the groups consisted of representatives of relevant professional groups, the views and preferences of the target population appear to have been sought, and the target users were clearly described. The authors conducted systematic literature searches, clearly outlined their selection criteria, described the quality of the body of evidence, and clearly described their processes for formulating the recommendations. The competing interests of members involved in developing the guidelines were recorded and addressed. The authors of the CDC guidelines provided a detailed process for selecting articles following preliminary screening.²⁸ All guidelines had their recommendations statements clearly linked to published evidence and followed an external expert review process. The guidelines were clearly presented, with the CDC providing the most comprehensive description of the guideline development process. The authors of the WHO guidelines suggested that the implementation of their guidelines could be facilitated through collaboration with international technical partners and stakeholders and indicated that the guideline would be updated with new evidence at least every five years.³⁰

Minor limitations were identified. One set of authors relied on generic descriptions of stakeholder involvement and some aspects of the rigour of development and editorial independence.²⁹ As such certain aspects specific to the guidelines on SSI could not be assessed. While the requirement to record and address competing interests was outlined in the generic descriptions of the guidelines, a statement with information specific to the guideline development group was not included.²⁹ For the CDC guidelines, the majority of the titles and abstracts were screened by one reviewer; whereas, about 10 percent of titles and abstracts were screened in duplicate.²⁸. The authors of the WHO guidelines suggested collaborating with others but did not provide details on tools that would facilitate the implementation of their guidelines. Potential resource implications of applying the recommendations were not addressed other than by the authors of the NICE guidelines who indicated that the incremental cost of replacing standard sutures with triclosan-coated sutures was minor relative to the estimated clinical benefit. The importance of establishing a supply chain for triclosan-coated sutures if the recommendations were adopted was not discussed in any of the guidelines, nor were the potential barriers to implementation addressed.

Assessing editorial independence was complex. None of the guidelines provided an explicit statement to indicate how the views of the funding body may or may not have influenced the content of the guideline. However, given that the WHO involved multiple panels of unaffiliated members, it implies that the WHO did not influence the guideline development process. There was insufficient information in the NICE and CDC guidelines to come to a similar conclusion.

Summary of Findings

A detailed summary of findings and recommendations are provided in Appendix 4, Table 8, Table 9 and Table 10.

Clinical Effectiveness and Safety of Triclosan on Single use Medical Devices and/or Consumables

A number of outcomes (i.e., SSIs, wound dehiscence, mortality,) were reported in the HTA¹⁹ and the SR,²⁰ however, the primary studies included in the HTA¹⁹ were fully captured by the SR,²⁰ thus the results of the more comprehensive SR are reported. The SR was more comprehensive as it included patients undergoing any non-dental surgery and included 30 studies, while the HTA was restricted to patients with abdominal surgery and included nine studies.

SSIs

The comparative clinical effectiveness of triclosan-coated sutures versus uncoated sutures for the prevention of SSIs was examined in all included studies. The SR found that the use of triclosan-coated sutures was associated with a statistically significant lower risk of SSIs compared to uncoated sutures.²⁰ The lower risk of SSIs in patients treated with triclosan-coated sutures was observed when the analyses included evidence from RCTs and NRS combined, RCTs alone, high-quality RCTs, and NRSs alone, but not in an analysis that only included evidence from low-quality RCTs.

Evidence from one high-quality RCT conducted in pediatric patients demonstrated a statistically significant lower risk of SSIs (deep or superficial), and a statistically significant lower risk of deep SSIs in patients treated with triclosan-coated sutures compared to uncoated sutures.²⁵

In adult patients, one RCT with a sample size of 177 patients reported statistically significantly fewer SSIs in the patients treated with triclosan-coated sutures (10.4%) compared to those treated with uncoated sutures (20.8%),²¹ however, it is unclear whether the study was adequately powered. Another RCT with 1,013 patients did not find any differences in SSI rate between the groups treated with triclosan-coated versus uncoated sutures (6.9% and 5.9%, respectively),²² although the use randomization block sizes of two may have introduced bias into the study. Three additional RCTs reported on SSIs, but these studies had high risk of bias due to poor reporting of outcomes,²³ quasi-randomization,²⁶ or not-accounting for confounders,²⁴. One reported statistically significantly fewer SSIs in the patients treated with triclosan-coated sutures,²⁴ while the other two did not observe any difference in SSIs between the two groups.²³^,²⁶

The NRS reported a statistically significant lower risk of SSI in patients treated with triclosan-coated sutures, but it is unclear whether the risk ratio was properly calculated.²⁷

Wound Dehiscence

Evidence regarding the comparative clinical effectiveness of triclosan-coated sutures versus uncoated sutures with respect to wound dehiscence was available from the HTA,¹⁹ the SR,²⁰ and two RCTs.²¹^,²⁵ Using evidence from RCTs and NRSs (examined together and separately), the SR found that triclosan-coated sutures did not reduce the risk of wound dehiscence compared to patients treated with uncoated sutures.²⁰ Evidence from two RCTs, one in adults²¹ and one in pediatric patients,²⁵ also demonstrated no difference in wound dehiscence when comparing patients treated with triclosan-coated versus uncoated sutures, although it is unclear whether the one RCT was adequately powered.²¹

Mortality

Evidence comparing mortality between patients treated with triclosan-coated sutures versus uncoated sutures was available in the the HTA,¹⁹ the SR,²⁰ one RCT²⁶, and the NRS.²⁷ The SR found that use of triclosan-coated sutures did not result in a difference in post-operative mortality when compared to patients treated with uncoated sutures.²⁰ Evidence from one RCT²⁶ and the NRS²⁷ also found no difference in mortality between the patients treated with triclosan-coated sutures compared to uncoated sutures, although the RCT used monthly randomization of the treatment centers.²⁶

Length of Stay

Length of stay in patients treated with triclosan-coated sutures compared to uncoated sutures was reported in the HTA,¹⁹ two RCTs,²⁴^,²⁶ and the NRS.²⁷ The HTA included evidence from seven RCTs, which they evaluated to have high or unclear risk of bias, of which one study reported a statistically significant shorter length of stay for patients treated with triclosan-coated sutures, and the other six studies reported no significant difference between groups.¹⁹ One RCT that used monthly treatment center randomization, reported no difference in length of stay between groups,²⁶ while the other RCT, which did not adjust for confounders or report details of the randomization procedure, reported a statistically significant higher length of stay in hospital and in the ICU in the patients treated with triclosan-coated sutures (7.46 and 2.98 days, respectively) compared to the control group (6.70 and 2.69 days, respectively).²⁴ The NRS reported a statistically significant short length of stay in the patients treated with triclosan-coated sutures, however, no outcome data was provided.²⁷

Antimicrobial use

Evidence from one high-quality RCT conducted in pediatric patients found a statistically significant lower use of antimicrobials due to SSIs in the patients treated with triclosan-coated sutures (2%) compared to the patients treated with control sutures (7%).²⁵

Wound Revision

One high-quality RCT conducted in pediatric patients reported statistically significantly fewer instances of wound revision in patients treated with triclosan-coated sutures (<1%) compared to those treated with uncoated sutures (2%).²⁵

Wound Condition

One RCT reported a significantly lower surface temperatures at the wound location in patients treated with triclosan-coated sutures compared to the control group at 3 months post-operatively.²³ However, this outcome was poorly described, the figure did not include simple outcome data, and a P value was only reported for the one significant time point.

Evisceration

Evisceration was reported in the NRS.²⁷ No patients treated with triclosan-coated or uncoated polyglactin 910 sutures (Vicryl) experienced evisceration. Statistically significantly fewer patients treated with the triclosan-coated polydioxanone (PDS) presented with evisceration compared to those treated with uncoated sutures.²⁷

Additional Outpatient Visits

One high-quality RCT conducted in pediatric patients reported that the number of additional outpatient visits with a physician or a nurse, was statistically significantly lower in patients treated with triclosan-coated sutures (4%) compared to patients treated with uncoated sutures (8%).²⁵

Readmission

Readmission rate was reported to be statistically significantly lower in patients treated with triclosan-coated sutures (1%) compared to patients treated with uncoated sutures (2%), in one high-quality RCT conducted in 1,557 pediatric patients.²⁵

Critical Care Admission

One RCT, that randomized the treatment centers on a monthly basis, reported no difference in critical care admission between patients treated with triclosan-coated or uncoated sutures.²⁶

Clostridium Difficile Infections

One RCT reported no difference in Clostridium difficile infections between patients treated with triclosan-coated or uncoated sutures, although the study used monthly block randomization of the treatment centers, rather than individual patient randomization.²⁶

Pain

Pain level was measured in one RCT using a visual analog scale, however, there were concerns with the outcome reporting in this study.²³ The pain was statistically significantly higher on the first post-operative day in the group treated with triclosan-coated sutures (8.6) compared to patients treated with uncoated sutures (8.1), but not at any of the other follow-up times.²³

Secondary surgery for wound complications

The proportion of patients requiring a secondary surgery for wound-related complications was reported in the HTA.¹⁹ Evidence from two RCTs, which the HTA authors assessed as having high or unclear risk of bias, indicated that patients treated with triclosan-coated sutures had a statistically significant lower rate of secondary surgery for would-related complications, compared to those treated with uncoated surgery. Evidence from a third RCT, that the HTA authors evaluated as having high risk of bias, had the opposite result, but no statistical test was reported to evaluate this finding.

Functional Scores

One RCT reported functional scores, assessed using knee range of motion and the SF-12, however, the tools used to assess this outcome were poorly described.²³ There was no difference in functional scores between the groups.

Quality of Life

Evidence for quality of life was reported in the HTA.¹⁹ This included evidence from one RCT that they evaluated to have unclear risk of bias, and found no difference in quality of life between the patients treated with triclosan-coated sutures or uncoated sutures.¹⁹

Adverse Events

Evidence for adverse events and serious adverse events was reported in the HTA.¹⁹ For adverse events, evidence from one RCT, that they evaluated to be of high risk of bias, found statistically significantly fewer inflammatory reactions to the sutures in patients treated with triclosan-coated sutures (7.5%) compared to those treated with uncoated sutures (17.5%).¹⁹ They also reported evidence from one RCT that they assessed to have unclear risk of bias, which found a statistically significant higher proportion of incision hematomas in the patients treated with triclosan-coated sutures (9.3%), compared to those treated with uncoated sutures (2.1%), but no differences in overall incision complications, incision swelling, incision redness, or incision seroma.¹⁹ The HTA also reported no difference in the incidence of incisional hernia from evidence from one RCT that they assessed to have high risk of bias.¹⁹For serious adverse events, evidence from one RCT, that they assessed to have unclear risk of bias, reported no difference in the frequency of serious adverse events.¹⁹ In addition, the HTA included evidence from two NRS, one of which did not include a comparator group, and the other did not see any difference in the proportion of patients with pancreatic fistulas or delayed gastric emptying.¹⁹

One RCT reported no difference in the proportion of patients who experience one or more post-operative complications between patients treated with triclosan-coated (12.37%) or uncoated sutures (12.42%),²⁶ however, this study randomized the treatment centers to the intervention or control sutures on a monthly basis.

Guidelines

Three evidence-based guidelines were identified that made recommendations for the use of triclosan in medical devices and/or consumables.²⁸^–³⁰ All three guidelines recommend considering the use of triclosan-coated sutures to prevent SSIs, however, the recommendations are based on low to moderate quality evidence in each guideline.

The NICE guideline recommends considering using antimicrobial triclosan-coated sutures, especially for pediatric surgery, to reduce the risk of SSI.²⁹ The recommendation was based on low- to high-quality evidence overall, and high-quality evidence in children. The uncertainty of the evidence is reflected in the wording of the recommendation.²⁹

The CDC guideline recommends considering the use of triclosan-coated sutures for the prevention of SSIs, but this is graded as a weak recommendation, based on moderate quality evidence.²⁸

The WHO guideline suggests the use of triclosan-coated sutures for reducing the risk of SSI, independent of surgery type. This recommendation is of ‘conditional’ strength (i.e., the benefits of the intervention probably outweigh the risks), as it is based on low to moderate quality evidence.³⁰

Limitations

There are various limitations associated with the evidence in this report on the use of triclosan on single use medical devices or consumables for infection prevention in hospitalized patients.

A key limitation was the availability of evidence on different medical devices. This report contains evidence on the use of triclosan-coated sutures versus uncoated sutures, but no evidence was identified on the use of triclosan on other single use medical devices or consumables. Therefore, it is unclear whether the findings from the triclosan-coated sutures are generalizable to other medical devices and consumables.

The body of evidence was heterogenous with regards to type of surgery; some studies focused on specific types of surgery (e.g., pilonidal disease), while other studies were broader (e.g., any non-dental surgery requiring sutures). This may limit the ability to combine data in a meta-analysis, and findings from one type of surgery may not be generalizable to another type of surgery. However, this heterogeneity may also be considered an advantage, as the broad population criteria ensured that all relevant populations were captured.

Most of the evidence in this report was from studies on adult patients. One RCT²⁵ specifically focused on pediatric patients, and the SR²⁰ did not restrict primary studies based on patient age, while the HTA¹⁹ and other primary studies²¹^–²⁴^,²⁶^,²⁷ were focused on adult patients. As such, some of the evidence from adult patients may not be generalizable to pediatric patients. However, the RCT²⁵ which examined children undergoing general or orthopedic surgery was a high-quality RCT. This is in line with the NICE guideline,²⁹ which found high-quality evidence demonstrating a benefit of triclosan-coated sutures in children.

None of the included publications were conducted in Canada or by Canadian authors, although the WHO guideline³⁰ is intended for global use. It is unknown if the results from the studies conducted outside of Canada are generalizable to Canadian clinical practice as there may be geographic differences between countries in the provision of care for the prevention of infections in hospitalized patients.

Numerous outcomes were captured in the body of evidence for this report, however, except for SSIs, most outcomes were reported in one to four studies, making it challenging to form definitive conclusions.

Conclusions and Implications for Decision or Policy Making

This report was comprised of one HTA,¹⁹ one SR,²⁰ six RCTs,²¹^–²⁶ and one NRS²⁷ regarding the comparative clinical effectiveness of triclosan-coated sutures versus uncoated sutures for the prevention of SSIs. Three evidence-based guidelines were summarized regarding the use of triclosan-coated sutures for the prevention of SSIs.²⁸^–³⁰

For the prevention of SSIs, one low-quality SR²⁰ found evidence that the use of triclosan-coated sutures was associated with a lower risk of SSIs compared to uncoated sutures. The reduction in risk of SSIs was observed in randomized and non-randomized studies, and high-quality studies, but not in low-quality trials. While this SR had low methodological quality according to the AMSTAR 2 criteria, it was the most comprehensive SR identified in this report, encompassing all types surgery, all ages of patients, RCTs, and NRS. The lower risk of SSIs with the use of triclosan-coated sutures observed in this SR²⁰ was similar to the findings of the HTA,¹⁹ which focused on RCTs for abdominal surgery, but was not presented in this report due to overlap. Similarly, some of the SRs¹⁴^,¹⁷ that were excluded from this report due to complete overlap of primary studies had concordant findings with regards to SSIs with the SR²⁰ included in this report.

Further evidence from primary studies on triclosan-coated sutures for the prevention of SSIs had mixed findings. Three RCTs of good,²⁵ moderate,²¹, and low,²⁴ quality, and one low-quality NRS²⁷ demonstrated a lower risk of SSIs with triclosan-coated sutures, while three RCTs of moderate,²² and low quality²³^,²⁶ did not observe any difference in SSI.

Overall, these findings for the prevention of SSIs are in line with the findings from a previous CADTH report from November 2014, which found clinical evidence of varying quality to indicate that the use of triclosan-coated sutures reduced the risk of SSI compared to uncoated sutures.³²

This report also found evidence that the use of triclosan-coated sutures was associated with additional benefits compared to uncoated sutures. For triclosan-coated sutures there was low- to high-quality evidence of reduced risk of wound dehiscence;²⁰^,²¹^,²⁵ high-quality evidence in pediatric patients of lower use of antimicrobials due to SSIs, fewer instances of wound revision, fewer outpatient visits, and lower readmission rate;²⁵ and low-quality evidence of lower surface temperature,²³ and fewer instances of evisceration.²⁷

Several outcomes included in this report had no difference between triclosan-coated and uncoated sutures. A moderate-quality HTA found evidence from one study with unclear risk of bias that there was no difference in quality of life,¹⁹ as well as evidence from one study with high risk of bias that there was no difference in incisional hernia.¹⁹ In addition, there was low-quality evidence that there was no difference between triclosan-coated and uncoated sutures for post-operative mortality,²⁰^,²⁶^,²⁷ critical care admission,²⁶ clostridium difficile infections,²⁶ pain,²³ functional score,²³ and complications.²⁶

For some of the outcomes included in this report, the findings were mixed. Evidence from low- to moderate-quality studies found mixed findings on whether triclosan-coated sutures affected length of stay.¹⁹^,²⁴^,²⁶^,²⁷ The moderate-quality HTA also reported mixed findings, from evidence from studies with high and unclear risk of bias, on the influence of triclosan-coated sutures on adverse events and the proportion of patients requiring a second surgery for wound-related complications.¹⁹

Overall, patients treated with triclosan-coated sutures had outcomes that were better or not different than patients treated with uncoated sutures. No evidence was identified to suggest that triclosan-coated sutures contributed to negative outcomes when compared to uncoated sutures.

Three evidence-based guidelines were identified, all of which recommend considering the use of triclosan-coated sutures for the prevention of SSIs, based on low- to high-quality evidence.²⁸^–³⁰

The limitations of the included studies and of this report should be considered when interpreting the findings. The findings highlighted in this review come with a moderate degree of uncertainty. Further well conducted RCTs addressing triclosan-coated versus uncoated sutures in the adult population may help to reduce uncertainty.

References

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22.: Ichida K, Noda H, Kikugawa R, et al. Effect of triclosan-coated sutures on the incidence of surgical site infection after abdominal wall closure in gastroenterological surgery: a double-blind, randomized controlled trial in a single center. Surgery. 2018 Mar 10;pii:S0039-6060(17)30893-0. [PubMed: 29402448]
23.: Lin SJ, Chang FC, Huang TW, Peng KT, Shih HN, Lee MS. Temporal change of Interleukin-6, C-reactive protein, and skin temperature after total knee arthroplasty using triclosan-coated sutures. BioMed Res Int. 2018;9136208. [PMC free article: PMC5820568] [PubMed: 29568771]
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25.: Renko M, Paalanne N, Tapiainen T, et al. Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: a double-blind, randomised controlled trial. Lancet Infect Dis. 2017;17(1):50–57. [PubMed: 27658562]
26.: Sprowson AP, Jensen C, Parsons N, et al. The effect of triclosan-coated sutures on the rate of surgical site infection after hip and knee arthroplasty: a double-blind randomized controlled trial of 2546 patients. Bone Joint J. 2018;100-b(3):296–302. [PMC free article: PMC6427932] [PubMed: 29589500]
27.: Ruiz-Tovar J, Alonso N, Ochagavia A, Arroyo A, Llavero C. Effect of the abdominal fascial closure with triclosan-coated sutures in fecal peritonitis, on surgical site infection, and evisceration: a retrospective multi-center study. Surg Infect (Larchmt). 2018;19(1):61–64. [PubMed: 29303687]
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Appendix 1. Selection of Included Studies

Appendix 2. Characteristics of Included Publications

Table 2Characteristics of Included Health Technology Assessments and Systematic Reviews and Meta-Analyses

First Author, Publication Year, Country	Literature Searched, and Numbers of Primary Studies Included	Eligibility criteria	Intervention and Comparator	Clinical Outcomes, Length of Follow-Up, Type of Surgery (number of studies)
HTA
European Network for Health Technology Assessment (EUnetHTA), 2017¹⁹ Croatia	Search: The following databases were searched until October 2016: The Cochrane Central Register of Controlled Trials, The Database of Abstracts of Reviews of Effects, The Health Technology Assessment Database, NHS Economic Evaluation Database, MEDLINE, EMBASE, and CINAHL Additionally, hand searching of reference lists of relevant studies was conducted, and the following clinical trials registries were searched in November 2016 for ongoing clinical trials and observational studies in November 2016: ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and the EU Clinical Trials Register. Included studies: 9 studies contributed data for this report Effectiveness: 7 RCTs Safety: 5 studies contributed data (3 RCTs and 2 NRS)	Inclusion criteria: Adult patients having elective or emergency open (laparotomy) or minimally invasive abdominal (i.e. laparoscopic) surgery. Sufficient methodological details were reported to allow critical appraisal of study quality; published in English; humans only Exclusion criteria: Studies using other methods of wound closure in the comparator arm (e.g. staples, or skin glue); primary or secondary studies which reported preliminary study results; no data provided for the outcomes of interest in an extractable format; papers with RCTs without sufficient methodological details to allow critical appraisal of study quality; published in a language other than English; duplicate of original publication.	Intervention: Absorbable antibacterial surgical sutures coated with triclosan (i.e., triclosan-coated Polyglactin 910 - Vicryl Plus, Monocryl Plus triclosan-coated Polyglecaprone, and triclosan-coated Polydioxanone - PDS Plus) Comparator: Non-antibacterial coated absorbable surgical suture (equivalent standard): (i.e. Vicryl, Monocryl, PDS II)	Primary outcomes: - Incidence of superficial and deep incisional SSIs, according to the CDC criteria^a - Mortality Secondary outcomes: - Quality of life - Length of hospital stay - Proportion of patients requiring secondary surgery for wound-related complications - Incidence of complete abdominal wound dehiscence within 30 days of surgery - Incidence of incisional hernia during the period of study follow-up - Adverse events Follow-up: up to 30 days post-operatively Type of surgery: - Colorectal (4 RCTs, 1 NRS) - Abdominal (2 RCTs, 1 NRS) - Fecal peritonitis (1 RCT) - hepatobiliary (1 NRS) - digestive tract (1 NRS) - gastric cancer (1 NRS) - colon cancer (1 NRS) - Pancreaticoduidenectomy (1 NRS)
SR and MA
Konstantelias, 2017²⁰ Greece	Search: Pubmed and Scopus databases until July 2016 Included studies: 19 RCTs 11 NRS	Inclusion criteria: controlled studies that compared the effectiveness of triclosan-coated sutures with uncoated sutures in humans, and the number of SSIs was reported Exclusion criteria: studies with fewer than 10 procedures; in vitro or animal studies; dentistry procedures; the number of SSIs was zero or not reported	Intervention: Triclosan-coated sutures Comparator: Uncoated sutures	Primary outcome: Development of SSI (any definition, superficial or deep) Secondary outcomes: - all-cause mortality - wound dehiscence Follow-up: two weeks to 12 months Type of surgery: - Colorectal (7 studies) - Cardiac or vascular (4 studies) - Lower limb (3 studies) - Breast (3 studies) - Abdominal (3 studies) - General surgery (3 studies) - Pilonial sinus (1 studies) - Cerebrospinal fluid (1 study) - Appendectomy (1 study) - Head and neck (1 study) - Digestive tract (1 study) - Pancreaticoduidenectomy (1 study) - Spinal (1 study)

: HTA = Health technology assessment; MA = meta-analysis; NRS = non-randomized study; RCT = randomized controlled trial; SR = systematic review; SSI = surgical site infection;
a: CDC criteria for superficial SSI: date of the event occurs within 30 days of operation AND involves only skin and subcutaneous tissue of incision, AND has at least one of the following, a) purulent drainage, b) organism(s) identified from an aseptically-obtained specimen, c) superficial incision is deliberately opened, testing of tissue is not performed AND patient has at least one sign or symptom (e.g., localized pain or tenderness, localized swelling, heat), c) diagnosis of superficial SSI by the surgeon, attending, physician, or other designee.³¹
: CDC criteria for deep SSI: date of event occurs within 30 or 90 days of operation, AND involves deep soft tissues of the incision, AND the patient has at least one of the following, a) purulent drainage, b) deep incision that spontaneously dehisces, or is deliberately opened AND organisms identified AND patient has at least one sign or symptoms (i.e., fever, localized pain or tenderness), c) an abscess or other evidence of infection.³¹

Table 3Characteristics of Included Primary Clinical Studies

First Author, Publication Year, Country

Study Design

Population Characteristics

Intervention and Comparator(s)

Clinical Outcomes, Length of Follow-Up

Randomized Controlled Trials

Olmez, 2019²⁴

Turkey

Study design: Randomized controlled trial; follow-up tests were done by a blinded researcher.

Setting: Single-centre; consecutive patients were enrolled in hospital between June 1, 2013 and June 1, 2014.

Objective: To compare triclosan-coated PDS with uncoated PDS sutures for abdominal facial closure after GI tract surgery.

Inclusion criteria: All patients (18 years or older) who underwent elective or urgent GI surgery for any reason

Excluded: Patients who had triclosan allergy, needed re-laparotomy in the first week after the initial operation, were left with an open abdomen, American Society of Anesthesiologists score IV, or who refused randomization.

Number of patients: 890 (445 in the triclosan group, and 445 in the control group).

Mean age (SD): 55.1 (16.3) in the triclosan group; 54.6 (16.9) in the control group.

Sex: 43.1% male in the triclosan group; 50.1% male in the control group (P = 0.037)

Intervention: Triclosan-coated monofilament polydioxanone 1/0 (PDS Plus)

Comparator: Standard monofilament polydioxanone 1/0 (PDS II)

Primary outcome: SSIs

Secondary outcomes: Length of ICU stay, and length of hospitalization.

Follow-up: Up to 30 days post-operative

Arslan, 2018²¹

Turkey

Study design: Randomized controlled trial; follow-up assessments were done by a blinded researcher.

Setting: Single-centre; patients recruited in hospital between January 2011 and January 2013.

Objective: To investigate the effect of triclosan-coated sutures on pilonidal disease surgery.

Inclusion criteria: Patients (> 18 years) who underwent wide excision and primary closure for pilonidal disease.

Excluded: The use of immunosuppression, anti-biotherapy, and/or infection history within 1 week before surgery, acute abscess, recurrent pilonidal disease, different procedures other than wide excision and primary closure, use of drain, and post-operative administration of antibiotics.

Number of patients: 177 (86 in the triclosan group, and 91 in the control group)

Mean age (SD): 25.6 (5.9)

Sex: 87.6% male

Intervention: Triclosan group

Retention: 1/0 triclosan-coated monofilament polydioxanone (PDS Plus)

Subcutaneous

tissue: 3/0 triclosan-coated polyglactin (Vicryl Plus)

Skin closure: 3/0 triclosan-coated monofilament polydioxanone (PDS Plus)

Comparator: Control group

Retention: 1/0 monofilament polypropylene (Prolene)

Subcutaneous

tissue: 3/0 polyglactin (Vicryl)

Skin closure: 3/0 polypropylene (Prolene)

Primary outcome: SSI rate

Secondary outcome:

Wound dehiscence without infection.

Follow-up: Up to 30 days post-operative

Ichida, 2018²²

Japan

Study design: Double-blind, randomized, controlled, parallel adaptive group-sequential superiority trial

Setting: Single-centre; Patients recruited from Saitama Medical Center between March 2014 and February 2017.

Objective: To yield reliable data regarding whether or not triclosan-coated sutures are effective for decreasing SSIs in abdominal wall closure after gastroenterologic surgery.

Inclusion criteria: Patients undergoing gastroenterological surgery

Excluded: Bacterial infection or use of antibiotic therapy prior to operation, presence of a contaminated abdominal cavity due to intestinal fistula or drainage tube, known allergy to triclosan, and pregnancy.

Number of patients: 1013 (508 in the triclosan group, 505 in the control group)

Mean age (SD): 67.0 (11.5) in the triclosan group; 67.5 (11.6) in the control group

Sex: 59.8% male in the triclosan group; 63.8% male in the control group

Intervention:

Abdominal fascia and peritoneum: polyglactin 910 antimicrobial sutures coated with triclosan (Vicryl Plus)

Skin closure: polydioxanone antimicrobial sutures coated with triclosan (PDS Plus)

Comparator:

Abdominal fascia and peritoneum: uncoated polyglactin 910 sutures (Vicryl)

Skin closure: uncoated polydioxanone sutures (PDS II)

Primary outcome: incidence of superficial or deep SSIs according to the CDC criteria^a

Secondary outcomes: none

Follow-up: up to 30 days post-operatively

Lin, 2018²³

Taiwan

Study design: Double-blind, randomized controlled trial.

Setting: Single-centre; patients were recruited from Chang Gung Memorial Hospital between June 2011 and May 2012.

Objective: To investigate whether triclosan-coated sutures prevent SSIs after total knee arthroplasty surgery by lowering the risk of local bacterial infection.

Inclusion criteria: Patients aged 55 to 85, diagnosed with degenerative osteoarthritis of the knee, and not having previously undergone surgery to the index knee.

Excluded: Patients with inflammatory arthritis, a history of cancer within 5 years, osteogenesis imperfecta, Paget’s disease, neurovascular disease of the lower extremities, liver cirrhosis, aspartate aminotransferase or alanine aminotransferase level more than twice the maximum normal, coagulopathy, low serum creatinine, renal failure, peripheral arterial occlusive disease, preoperative international normalized ratio over 1.5 at screening, American Society of Anesthesiologists physical classification system score over 3, or immunocompromised.

Number of patients: 102(51 in the triclosan group; 51 in the control group)

Mean age (SD): 70.7 (7.4)

Sex: 25.5% male

Intervention: triclosan-coated polyglactin sutures (Vicryl Plus)

Comparator: plain polyglactin sutures

Primary outcome: Incidence of SSI within 3 months of surgery

Secondary outcomes: Length of hospital stay, pain level, functional scores, wound condition.

Follow-up: Within 3 months postoperatively.

Sprowson, 2018²⁶

United Kingdom

Study design: Two-arm, parallel-group, quasi-randomized controlled trial with block treatment allocation.

Setting: Three centres; patients recruited from all elective admissions at teaching acute hospital and elective centres between May 2008 and November 2013.

Objective: To determine if using a triclosan-coated suture can significantly reduce the rate of SSI after primary total hip arthroplasty or total knee arthroplasty.

Inclusion criteria: Patients (> 18 years), medically fit for an operation and suitable for primary total hip or knee arthroplasty.

Excluded: Revision arthroplasty, patients who are unable to consent.

Number of patients: 2546 (1223 in the triclosan group, 1323 in the control group).

Mean age (SD): 67.5 (10) in the triclosan group, 67.2 (9.7) in the control group.

Sex: 46% male in the triclosan group, 45.6% male in the control group.

Intervention: Triclosan-coated Vicryl plus sutures.

Comparator: standard Vicryl sutures.

For both groups, the layer closed with the Vicryl was dependent on the preference of the surgeon (from deep fascia to the subcutaneous layer).

Primary outcome: superficial SSI within 30 days, based definitions published by the Health Protection Agency (which originate from the CDC).^a

Secondary outcomes:

-: deep SSI within 30 days of surgery if no implant, or within a year if an implant is in place
-: mortality at 30 and 90 days
-: length of stay (days
-: Clostridium difficile infections
-: complications
-: critical care admission

Follow-up: Up to 30 days for the primary outcome.

Up to 30 days, 90 days, and 1 year for secondary outcomes.

Renko, 2017²⁵

Finland

Study design:

Randomized, double-blind, controlled, parallel-group study

Setting: Single-centre; patients were recruited to Oulu University Hospital between September 2010 and December 2014.

Objective: To investigate whether the use of triclosan-containing sutures in pediatric patients unselected by surgery could lead to a clinically relevant reduction in the occurrence of SSIs.

Inclusion criteria: Children (< 18 years) staying in the pediatric surgery and orthopedic ward for any elective or emergency surgery scheduled during the daytime and with anticipated use of absorbing sutures.

Excluded: Children having procedures for foreskin, cleft lip, or cleft palate. Children in the neonatal ICU or oncological ward.

Number of patients: 1557 (778 in the triclosan group; 779 in the control group)

Mean age (SD): 7.2 (5.4) in the triclosan group; 7.1 (5.5) in the control group

Sex: 62% male in the triclosan group; 64% male in the control group

Intervention: Polyglactin 910, poliglecaprone 25, or polydioxanone biodegradable sutures with coating or impregnated with triclosan (triclosan group)

Comparator: Polyglactin 910, poliglecaprone 25, or polydioxanone biodegradable sutures without triclosan (control group)

In both groups, all three suture materials were available to ensure various pull-out strengths and resorption times for different types of surgery.

Primary outcome: the occurrence of superficial or deep SSI (according to the CDC prevention criteria)^a

Secondary outcomes: Wound dehiscence, number of extra visits to a nurse or physician, readmission, wound revision, antimicrobial use

Follow-up: within 30 days

Non-Randomized Studies

Ruiz-Tovar, 2018²⁷

Spain

Study design:

Retrospective cohort study

Setting: Three hospitals, between January 2014 and December 2015.

Objective: To evaluate retrospectively the effect on incisional SSI and evisceration of using different types of triclosan-coated sutures (polyglactin and polydioxanone) in the abdominal fascial closure in patients with fecal peritonitis.

Inclusion criteria: Intra-operative diagnosis of fecal peritonitis secondary to acute diverticulitis perforation, neoplastic tumor perforation, or colorectal anastomotic leak of previous elective colorectal resection.

Excluded: Laparoscopic approach, technique other than Hartmann procedure, re-operations for reasons other than anastomotic leak, and 30-day post-operative mortality.

Number of patients: 104 (26 Vicryl, 25 Vicryl Plus, 33 PDS, 20 PDS Plus).

Mean age (SD): 64.7 (15.5)

Sex: 41.3% male

Four groups based on fascial closure with the following running loop sutures:

Vicryl: polyglactin 910, size 1

Vicryl Plus: triclosan-coated polyglactin 910, size 1

PDS: polydioxanone, size 1

PDS Plus: triclosan-coated Polydioxanone, size 1

Outcome: Incisional SSI, as defined by the CDC, and evisceration (disruption of the fascial suture and presence of viscera outside of the abdominal cavity), mortality, and hospital stay.^a

Follow-up: Up to 30 days for SSI, not reported for other outcomes.

: CDC = Centers for Disease Control and Prevention; GI = gastrointestinal; PDS = polydioxanone; SSI = surgical site infection;
a: CDC criteria for superficial SSI: date of the event occurs within 30 days of operation AND involves only skin and subcutaneous tissue of incision, AND has at least one of the following, a) purulent drainage, b) organism(s) identified from an aseptically-obtained specimen, c) superficial incision is deliberately opened, testing of tissue is not performed AND patient has at least one sign or symptom (e.g., localized pain or tenderness, localized swelling, heat), c) diagnosis of superficial SSI by the surgeon, attending, physician, or other designee.³¹
CDC criteria for deep SSI: date of event occurs within 30 or 90 days of operation, AND involves deep soft tissues of the incision, AND the patient has at least one of the following, a) purulent drainage, b) deep incision that spontaneously dehisces, or is deliberately opened AND organisms identified AND patient has at least one sign or symptoms (i.e., fever, localized pain or tenderness), c) an abscess or other evidence of infection.³¹

Table 4Characteristics of Included Guidelines

First Author, Publication Year

Scope, Interventions, Intended Users, Target Population

Evidence Collection, Selection, Critical Appraisal and Synthesis

Recommendations Formulation, Evaluation, and Validation

Recommendation and Grading System

NICE, 2019²⁹

Scope:

Methods used before, during and after surgery to prevent and treat SSIs

Interventions:

Triclosan-coated sutures

Intended Users:

Healthcare professionals, commissioners and providers, people having surgery, their families and carers

Target population:

Adults, young people and children who require wound closure following a surgical procedure involving a cut through the skin

A systematic search of the literature review for of RCTs and SRs of RCTs, until May 2018.

Titles and abstracts are screened (a predetermined percentage are double-screened)

The evidence review process involves critical appraisal (with Cochrane Risk of Bias Tool), extracting and synthesizing the results, assessing quality/certainty in the evidence, and interpreting the results

A generic guideline development process was cited:

A guideline developer and committee compile clinical and research recommendations including the context in which the guidelines are being developed, a summary of the evidence, comparison with existing guidelines, summaries of the committee’s discussions, a rationale for the recommendations and their likely impact.

For each outcome, the committee reviews GRADE tables containing the number, type and quality of the studies for each question, and an overall rating of confidence (high, moderate, low or very low) in estimates of effect

Stakeholders review draft guidelines and provide comments online

Feasibility testing and additional consultation may be conducted at the discretion of the guideline developer

External expert review is not routine

The certainty or the confidence in the findings is assessed at the outcome level using GRADE.

The strength of the recommendation statement is reflected in its wording, namely (in decreasing order of certainty in the evidence): interventions that 1) must or must not be used, 2) should or should not be offered, or 3) could be offered or considered

CDC, 2017²⁸

Scope:

Prevention of SSIs

Interventions:

Triclosan-coated sutures

Intended Users:

Not reported

Target population:

Patients undergoing surgery

A targeted systematic search of the literature for SRs and RCTs was conducted from 1998 through April 2014; titles and abstracts were screened by one reviewer (10% were reviewed by a second appraiser); two reviewers evaluated full texts

A modified GRADE approach was used to assess the quality of the evidence

Recommendations were formulated based on current evidence. Explicit associations between the evidence and recommendations were made

The guidelines were validated by cross-referencing recommendations with those found in other guidelines

Members of an expert panel, the Healthcare Infection Control Practices Advisory Committee and members of the public reviewed draft guidelines

A modified GRADE approach was used to determine the strength of the recommendation.

Levels of evidence were categorized as follows:

IA - Strong recommendation supported by highto-moderate quality evidence suggesting net clinical benefits or harms.

IB - Strong recommendation supported by low-quality evidence suggesting net clinical benefits or harms, or an accepted practice supported by low-to-very low-quality evidence.

IC - A strong recommendation required by state or federal regulation.

II - A weak recommendation supported by any quality evidence suggesting a trade off between clinical benefits and harms.

No recommendation/unresolved - An unresolved issue for which there is either low-to-very low-quality evidence with uncertain tradeoffs between benefits and harms or no published evidence on outcomes deemed critical to weighing the risks and benefits of a given intervention.

Category I recommendations are all considered strong and should be equally implemented; only the quality of the evidence underlying the recommendation(s) distinguishes the levels. Category II recommendations are considered weak recommendations to be implemented at the discretion of individual institutions as supplementary procedures - never in place of Category I recommendations - and are not intended to be systematically and routinely enforced.

WHO, 2016³⁰

Scope:

Prevention of SSIs

Interventions:

Triclosan-coated sutures

Intended Users:

surgeons, nurses, technical support staff, anesthetists and other professionals directly providing surgical care; pharmacists, sterilization unit staff, policy-makers, senior managers and infection prevention and control professionals

Target population:

Global population

The WHO Guideline Steering Group, the Guidelines Development Group, and a methodologist identified primary critical outcomes and priority topics and formulated research questions

The Systematic Reviews Expert Group conducted 27 systematic reviews using standardized methods between December 2013 and October 2015. RCTs and NRS published after January 1 1990, were eligible for inclusion.

The evidence was synthesized using the GRADE approach

Followed the 2014 WHO Handbook for Guideline development

Four technical consultations between June 2014 and November 2015 to formulated recommendations. Modifications were based either on comments by the external peer reviewers or on emerging new evidence.

The direction and strength of each recommendation was driven by the quality of evidence, the balance between benefits and harms, the values and preferences of stakeholders, the resource implications of the intervention, and other factors.

The quality of the evidence was assessed according to the following GRADE categories: High: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect.

The strength of recommendations was rated as either “strong” (the panel was confident that the benefits of the intervention outweighed the risks) or “conditional” (the panel considered that the benefits of the intervention probably outweighed the risks).

: CDC = Centers for Disease Control and Prevention; GRADE = Grading of Recommendations, Assessment, Development, and Evaluation; NICE = National Institute for Health and Care Excellence; SSI = surgical site intervention; WHO = World Health Organization

Appendix 3. Critical Appraisal of Included Publications

Table 5Strengths and Limitations of Health Technology Assessments and Systematic Reviews and Meta-Analyses using AMSTAR 2⁶

Strengths	Limitations
Health Technology Assessments
EUnetHTA, 2017¹⁹
- Well described research question and inclusion criteria - Includes RCTs for effectiveness, and both RCTs and NRS for safety - Comprehensive body of literature was searched - Study selection and data extraction performed in duplicate - Thorough reporting of the characteristics of the primary studies - Risk of bias of RCTs assessed with Cochrane Risk of Bias tool - Reported funding source of primary studies - Random effects meta-analyses of primary outcome, with reporting of heterogeneity - Heterogeneity of the studies was considered in the analysis - All authors declared no conflicts of interest	- No written protocol - Does not provide list of excluded studies - Quality of individual NRSs not assessed (rather all NRS assumed to be of low quality) - Studies with high risk of bias included in the discussion of the results - No investigation of publication bias
Systematic Reviews and Meta-Analyses
Konstantelias, 2017²⁰
- Well described research question and inclusion criteria - Comprehensive body of literature - Includes both RCTs and NRSs - Study selection performed in duplicate - Primary study details provided - Newcastle-Ottawa Scale used to assess quality of NRSs - Reported whether the primary studies were funded by the suture manufacturer - Random effects meta-analyses, with reporting of heterogeneity - Sensitivity analyses for meta-analyses [e.g., study design (RCT, NRS), quality of study (low vs. high risk of bias)] - Heterogeneity of the studies was considered in the analysis - Scientific quality of individual studies considered when synthesizing evidence - Publication bias assessed with a funnel plot - The authors report no conflicts of interest	- No written protocol - Data extraction not performed in duplicate - Does not provide list of excluded studies - Jadad criteria used to assess quality of RCTs - Some meta-analyses inappropriately combined RCTs and NRSs - Not all details reported for all meta-analyses (e.g., heterogeneity, number of procedures, study design)

: NRS = non-randomized study; RCT = randomized controlled trial;

Table 6Strengths and Limitations of Clinical Studies using the Downs and Black Checklist⁷

Strengths	Limitations
Randomized Controlled Trials
Olmez, 2019²⁴
The objectives, interventions, and controls were clearly described Source of patient population and eligibility criteria were well described Actual probability (P values) were reported All patients received the assigned intervention Minimal loss to follow up in both groups The authors reported no conflicts of interest	Randomization procedure was not well described There were a number of significant differences between the baseline patient characteristics of the two groups which were not accounted for in the analysis. Some of these differences (e.g., smoking status, whether the surgery was an emergency, and the target organ for the surgery), may have influenced the results. Adverse events were poorly reported Findings overstated in the discussion
Arslan, 2018²¹
The objectives, interventions, controls, and main outcomes were clearly described Outcome assessments performed by surgeon blinded to the intervention All patients received the assigned intervention Actual probability (P values) were reported Appropriate statistical analysis	Methods for sampling patients from the source population were not described Randomization and allocation procedures were not well described Sample size not calculated Sutures type differed for two of the surgical steps (Prolene vs. PDS), which may have outcomes (particularly wound dehiscence) Did not report adverse events Did not mention conflicts of interest or source of funding
Ichida, 2018²²
The objectives, interventions, controls, and main outcomes were clearly described Treatment groups were well matched for baseline characteristics and potential confounders No loss to follow-up Randomization was well concealed, and surgeons assessing the outcomes and patients were blinded to the treatment group Actual probability (P values) were reported Calculated sample size was met	Randomization methods were weak (i.e., block randomization with an allocation ratio of 1:1 and block size of 2) Used a modified intention-to-treat analysis, but did not report how many patients received the intervention to which they were assigned, and how many patients received the opposite intervention Did not report adverse events Did not mention conflicts of interest or source of funding
Lin, 2018²³
The objectives, interventions, and controls were clearly described Actual probability (P values) were reported The surgeons, study nurse who assessed the outcomes, and the patients were all blinded to the treatment group All patients received the assigned intervention No loss to follow-up The authors reported no conflicts of interest	A lack of detail describing the main outcomes (e.g., definitions, assessment methods) Reliability and validity of tools used to measure functional scores is unclear due to insufficient information Data is selectively reported (e.g., no data reported for length of stay) Simple outcome data was not reported for all outcomes Did not report adverse events
Sprowson, 2018²⁶
The objectives, interventions, controls, confounders, and main outcomes were clearly described All patients received the assigned intervention Treatment groups were well matched for baseline characteristics and potential confounders Patients and research team who assessed outcomes were blinded to the intervention Actual probability (P values) were reported Reports that no benefits in any form have been received or will be received from a commercial party related directly or indirectly to the research	Quasi-randomized by monthly block allocation of treatment centres to control or intervention groups Surgeons not blinded to randomization Did not report whether authors had any conflicts of interest
Renko, 2017²⁵
Strong RCT methodology The objectives, interventions, controls, and main outcomes were clearly described Source of patient population, recruitment process, and eligibility criteria were well described Thoroughly described randomization process, and the blinding of patients and investigators Main outcome measure used was valid Appropriate statistical analysis Results clearly presented and appropriately interpreted Actual probability (P values) were reported Calculated sample size was met Authors report no role of the funding source in the study	Does not report percentage of different suture types used (e.g., polyglactin 910, poliglecaprone 25, or polydioxanone) Initial detection of possible infection relied on parent response to an online questionnaire Single-centre study (conducted in Finland), may not be generalizable to other centres
Non-Randomized Studies
Ruiz-Tovar, 2018²⁷
The objectives, interventions, controls, and main outcomes were clearly described All patients within a group had received that intervention (retrospective study) No patients were lost to follow-up The authors reported no conflicts of interest	Retrospective cohort, therefore, no randomization and no blinding Confounders, specifically comorbidities, were not reported by group of patients, and were not taken into account in the analysis Uncertain whether risk ratio was calculated correctly Uncertain whether main findings (e.g., risk ratio) were interpreted correctly Actual probability (P values) were reported for significant findings, but otherwise reported as ‘not significant’ Sample size not calculated

: RCT = randomized controlled trial

Table 7Strengths and Limitations of Guidelines using AGREE II⁸

Item	Guideline
Item	NICE, 2019²⁹	CDC, 2017²⁸	WHO, 2016³⁰
Domain 1: Scope and Purpose
1. The overall objective(s) of the guideline is (are) specifically described.	Yes	Yes	Yes
2. The health question(s) covered by the guideline is (are) specifically described.	Yes	Yes	Yes
3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.	Yes	Yes	Yes
Domain 2: Stakeholder Involvement
4. The guideline development group includes individuals from all relevant professional groups.	Yes^a	Yes	Yes
5. The views and preferences of the target population (patients, public, etc.) have been sought.	Yes^a	Yes	Yes
6. The target users of the guideline are clearly defined.	Yes	Yes	Yes
Domain 3: Rigour of Development
7. Systematic methods were used to search for evidence.	Yes	Yes	Yes
8. The criteria for selecting the evidence are clearly described.	Yes^a	Yes	Yes
9. The strengths and limitations of the body of evidence are clearly described.	Yes	Yes	Yes
10. The methods for formulating the recommendations are clearly described.	Yes	Yes	Yes
11. The health benefits, side effects, and risks have been considered in formulating the recommendations.	Yes	Yes	Yes
12. There is an explicit link between the recommendations and the supporting evidence.	Yes	Yes	Yes
13. The guideline has been externally reviewed by experts prior to its publication.	Yes^a	Yes	Yes
14. A procedure for updating the guideline is provided.	Yes	No	Yes
Domain 4: Clarity of Presentation
15. The recommendations are specific and unambiguous.	Yes	Yes	Yes
16. The different options for management of the condition or health issue are clearly presented.	Yes	Yes	Yes
17. Key recommendations are easily identifiable.	Yes	Yes	Yes
Domain 5: Applicability
18. The guideline describes facilitators and barriers to its application.	No	No	Partially
19. The guideline provides advice and/or tools on how the recommendations can be put into practice.	No	No	Partially
20. The potential resource implications of applying the recommendations have been considered.	Partially	No	No
21. The guideline presents monitoring and/or auditing criteria.	No	No	Partially
Domain 6: Editorial Independence
22. The views of the funding body have not influenced the content of the guideline.	No	No	Yes
23. Competing interests of guideline development group members have been recorded and addressed.	Yes^a	Yes	Yes

: CDC = Centers for Disease Control and Prevention; NICE = National Institute for Health and Care Excellence; WHO = World Health Organization
a: Assessment made from the generic description of the NICE guideline methodology

Appendix 4. Main Study Findings and Authors’ Conclusions

Table 8Summary of Findings of the Health Technology Assessment and Systematic Review and Meta-Analysis

Main Study Findings	Authors’ Conclusion
Health Technology Assessment
EUnetHTA, 2017¹⁹
Length of stay, days, mean (SD): 1 RCT (high RoB, author’s appraisal): 1.2 (1.3) triclosan vs. 21.4 (2.8) control, (P < 0.05) 6 RCTs (4 high RoB, 2 unclear RoB, author’s appraisal): not significant between groups Proportion of patients requiring secondary surgery for wound-related complications: 3 RCTs (2 high RoB, 1 unclear RoB, author’s appraisal) 1 RCT (high RoB): 1% triclosan vs. 8.8% control (P < 0.05) 1 RCT (high RoB): 25.8% triclosan vs. 11.9% control (P = NR) 1 RCT (unclear RoB): 1.9% triclosan vs. 4.5% control; OR = 0.40 (95% CI, 0.18 to 0.88), P = 0.01 The incidence of incisional hernia during the period of study follow-up: 1 RCT (high RoB, author’s appraisal): 2.2% triclosan vs. 5.5% control (P = 0.235) Quality of life: 1 RCT (unclear RoB, author’s appraisal) EQ-5D visual analogue scale, mean (SD) = 69.2 (20.1) triclosan vs. 68.2 (19.6) control, P = 0.34 EQ-5D index, mean (SD): 0.9 (0.2) vs. 0.8 (0.2), P = 0.18 Adverse events: 2 RCTs 1 RCT (high RoB, author’s appraisal): inflammatory reaction to the sutures = 7.5% triclosan vs. 17.5% control (P < 0.05) 1 RCT (unclear RoB, author’s appraisal): Overall incision complications = 45.7% triclosan vs. 38.3% control; OR = 4.71, 95% CI, 1.31 to 16.91, P = 0.21 Incision hematoma: 9.3% triclosan vs. 2.1% control; OR = 4.71, 95% CI, 1.31 to 16.91, P = 0.02 Incision swelling: 18.6% triclosan vs. 14.2% control; OR = 1.38, 95% CI, 0.73 to 2.61, P = 0.322 Incision redness: 30.7% triclosan vs. 26.9% control; OR = 1.20, 95% CI, 0.71 to 2.02, P = 0.486 Incision seroma: 22.9% triclosan vs. 22.1% control; OR = 1.05, 95% CI, 0.60 to 1.84, P = 0.861 Serious adverse events: 1 RCT, 2 NRS Frequency: 1 RCT (unclear RoB): 25% triclosan vs. 23% control (P = 0.39) 1 NRS (n = 916): reported 6 patients with respiratory problems, and 2 patients with fluid collection in the intra-abdominal cavity in patients with triclosan sutures (no comparator group). 1 NRS (n = 198): pancreatic fistula = 25% triclosan vs. 23.7% control (P = 0.371); delayed gastric emptying = 9% triclosan vs. 14.6% control (P = 0.32)	“The length of hospital stay was an outcome in all 7 RCTs included in this SR; only in one RCT the length was statistically different in favour of the triclosan-coated surgical sutures group” (p91) “Regarding the other secondary outcomes assessed in our SR, no conclusion could be made due to the lack of or different results of reported data.” (p91) “The relative safety of triclosan-coated sutures could not be confirmed due to a lack of reporting of AEs in RCTs and nonRCTs included in our assessment” (p99)
Systematic Review
Konstantelias, 2017²⁰
The following meta-analyses were presented for the prevention of SSIs when triclosan-coated sutures were compared to uncoated sutures: SSIs reported in all studies (RCT and NRS): RR = 0.68, 95% CI, 0.57 to 0.81 P < 0.0001 I² = 56% Tau² = 0.12 Chi² = 68.71; df = 30 (P < 0.0001) Number of studies: 30 Number of procedures: 15, 385 SSIs reported in RCTs only: RR = 0.75, 95% CI, 0.63 to 0.91 P = 0.003 I² = 34% Tau² = 0.05 Chi² = 28.80 df = 19 (P = 0.07) Number of studies: 19 Number of procedures: 6747 SSIs reported in high Quality RCTs (Jadad score of 4 or 5): RR = 0.77, 95% CI, 0.62 to 0.97 P = 0.03 I² = 40% Tau² = 0.05 Chi² = 15.03 df = 9 (P = 0.09) Number of studies: 10 Number of procedures: 3915 SSIs reported in low quality RCTs (Jadad score of ≤3): RR = 0.71, 95% CI, 0.50 to 1.01 P = 0.05 I² = 34% Tau² = 1.10 Chi² = 13.64 df = 9 (P = 0.14) Number of studies: 9 Number of procedures: 2832 SSIs reported in NRSs only: RR = 0.57, 95% CI, 0.40 to 0.81 P = 0.002 I² = 70% Tau² = 0.20 Chi² = 33.41 df = 10 (P = 0.0002) Number of studies: 11 Number of procedures: 8638 The following meta-analyses was presented for the secondary outcomes when triclosan-coated sutures were compared to uncoated sutures: Wound dehiscence (RCT and NRS): RR = 0.82, 95% CI, 0.63 to 1.06 I² = 0% Number of studies: 6 Number of procedures: 2187 Wound dehiscence (RCT only): RR = 0.83, 95% CI, 0.59 to 1.17; I² = 14% Number of studies: 4 Wound dehiscence (NRS only): RR = 0.35, 95% CI, 0.05 to 2.27; I² = 0% Number of studies: 2 Mortality (RCT and NRS): RR = 0.87, 95% CI, 0.46 to 1.64 I² = 52% Number of studies: 3 (2 RCT, 1 NRS) Number of procedures: 3549	“This meta-analysis supports the use of triclosan-coated sutures for reducing the risk of SSIs. A significant benefit of fewer SSIs was found in comparisons of randomized, double-blind, and high-quality studies” (p143) “We sought to investigate the role of triclosan-coated sutures, as part of the secondary outcomes, in wound dehiscence and all-cause mortality. No statistically significant associations were observed.” (p144)

: CI = confidence interval; NR = not reported; NRS = non-randomized study; OR = odds ratio; RCT = randomized controlled trial; RoB = risk of bias; RR = risk ratio; SD = standard deviation; SSI = surgical site infection;

Table 9Summary of Findings of Included Primary Clinical Studies

Main Study Findings						Authors’ Conclusion
Randomized controlled trials
Olmez, 2019²⁴
SSI: 85/445 (19.1%) triclosan group vs. 115/445 (25.8%) control group (P = 0.016) ICU stay, days (mean (SD)): 2.98 (1.0) triclosan group vs. 2.69 (0.8) control group (P = 0.001) Hospital stay, days (mean (SD)): 7.46 (1.7) triclosan group vs. 6.70 (2.2) control group (P < 0.0001) Adverse events One patient in the triclosan group, and three patients in the control group died (excluded from sample size or analysis). No other adverse events were reported.						“This study found that using triclosan-coated sutures to close the fascia after laparotomy reduced the SSI rate by as much as 24%.” (p6) “The use of triclosan coated suture for closing laparotomy incisions may reduce the rate of SSIs in all subgroups of incision classifications in a single-center experience” (p6)
Arslan, 2018²¹
SSI: 9/86 (10.4%) triclosan group vs. 19/91 (20.8%) control group (P = 0.044) Wound dehiscence: 10/86 (11.6%) triclosan group vs. 5/91 (5.5%) control group (P = 0.116) Time to healing, days [mean (SD)]: 17.6 (7.1) triclosan group vs. 17.9 (6.4) control group						“We observed a significant decrease—more than 2-fold—on SSI rate with triclosan coated sutures.” (p1450) “Moreover, higher wound dehiscence rate in the triclosan group was remarkable, and even this difference was not statistically significant.” (p1450)
Ichida, 2018²²
Primary analysis was a modified intention-to-treat which excluded from the analysis the patients who did not receive any of the allocated interventions, but otherwise patients were analyzed based on the suture type they were randomized to receive. SSI: 35/508 (6.9%) triclosan group vs. 30/505 (5.9%) control group (95% CI, 0.686 to 2.010, P = 0.609) Superficial SSI: 23/508 (4.5%) triclosan group vs. 19/505 (3.7%) control group (P = 0.637) Deep SSI: 12/508 (2.4%) triclosan group vs. 11/505 (2.2%) control group (P >0.999)						“In conclusion, this large RCT at a single center showed that triclosan-coated sutures did not decrease the incidence of SSI after abdominal wall closure of gastroenterologic surgery.” (p95)
Lin, 2018²³
Superficial SSI: 0/51 (0%) triclosan group vs. 2/51 (3.9%) control group (P = 0.495) Deep SSI: no deep SSI were found in either group Wound condition: Surface temperature: significantly lower surface temperatures in the triclosan group than in the control group at 3 months post-operatively (P = 0.022) (reported as a figure) Length of hospital stay: not reported Functional Scores: Knee range of motion (Knee Society Score): Baseline: 40.8 (9.8) triclosan vs. 42.4 (10.6) control (P = 0.280) Post-op 2 weeks: 45.6 (10.1) triclosan vs. 48.7 (9.7) control (P = 0.126) Post-op 4 weeks: 55.5 (8.8) triclosan vs. 55.1 (9.3) control (P = 0.834) Post-op 3 months: 61.7 (7.4) triclosan vs. 63.2 (6.2) control (P = 0.279) SF-12: Baseline: 39.7 (18.1) triclosan vs. 40.9 (17.4) control (P = 0.739) Post-op 2 weeks: 12.2 (29.4) triclosan vs. 10.2 (22.5) control (P = 0.705) Post-op 4 weeks: 46.6 (33.9) triclosan vs. 49.5 (33.0) control (P = 0.666) Post-op 3 months: 76.7 (30.9) triclosan vs. 80.3 (24.3) control (P = 0.525) Pain, visual analog scale score [mean (SD)]: Baseline: 6.6 (1.7) triclosan vs. 7.0 (1.8) control (P = 0.280) Post-op day 1: 8.6 (1.0) triclosan vs. 8.1 (0.9) control (P = 0.017) Post-op day 3: 6.7 (1.0) triclosan vs. 6.4 (0.8) control (P = 0.131) Post-op 2 weeks: 5.1 (1.6) triclosan vs. 4.6 (1.5) control (P = 0.104) Post-op 4 weeks: 3.4 (1.5) triclosan vs. 3.4 (1.9) control (P = 0.974) Post-op 3 months: 1.7 (1.5) triclosan vs. 1.5 (1.5) control (P = 0.447)						“We analyzed the efficacy of triclosan-coated sutures for reducing SSIs and preventing deep PJIs after TKA by rigorously evaluating wounds, measuring inflammatory markers, monitoring skin temperature, and assessing functional outcomes. However, because there were only two superficial SSIs in the control group and none in the triclosan group, we were unable to arrive at any conclusions about their protective efficacy against SSIs” (p3) “The functional outcomes of the patients in the present study improved in both groups; however, there were no important significant differences between the groups throughout the 3-month postoperative follow-up.” (p6) “Thus, using triclosan-coated sutures to close the wounds of primary TKAs had no significant effect on postoperative clinical outcomes or knee inflammation.” (p6)
Sprowson, 2018²⁶
Superficial SSI: 8/1164 (0.7%) triclosan vs. 11/1273 (0.8%), (P = 0.651) Unadjusted odds ratio = 0.78, 95% CI, 0.27 to 2.15 Adjusted odds ratio = 0.78, 95% CI, 0.30 to 1.93 (adjusted for age and gender) Deep SSI: 13/1164 (1.1%) triclosan vs. 21/1273 (1.6%), (P = 0.300) Deep and superficial SSI: 21/1164 (1.8%) triclosan vs. 32/1273 (2.5%), (P = 0.266) Mortality: 2/1150 (0.2%) triclosan vs. 4/1269 (0.3%), (P = 1.000) Critical care admission: 19/1164 (1.6%) triclosan vs. 23/1273 (1.8%), (P = 0.758) Length of stay: 3.9 days triclosan vs. 4.1 days control, (P = 0.389) Clostridium difficile infections: 0.09% triclosan vs. 0% control, P = NA One or more post-operative complications: 12.37% triclosan vs. 12.42% control, (P = 1.000) Possible complications included: deep vein thrombosis, pulmonary embolism, stroke, transient ischemic attack, gastrointestinal bleed, renal failure, urinary tract infection, myocardial infarction, pneumonia, thrombocytopenia, readmission. No difference in the rate of complications between groups.						“We found that using a triclosan-coated suture material did not reduce the rate of superficial or overall SSI in primary total hip arthroplasty and total knee arthroplasty, in this randomized clinical trial.” (p299)
Renko, 2017²⁵
Primary analysis was a modified intention-to-treat analysis (i.e., patients were analyzed based on the suture type they were randomized to receive). Any SSI: 20/778 (3%) patients allocated to triclosan group vs. 42/779 (5%) of patients allocated to control group RR = 0.48, 95% CI, 0.28 to 0.80 P = 0.004 Superficial SSI: 17/778 (2%) patients allocated to triclosan group vs. 28/779 (4%) of patients allocated to control group RR = 0.61, 95% CI, 0.34 to 1.09 P = 0.100 Deep SSI: 3/778 (<1%) patients allocated to triclosan group vs. 14/779 (2%) of patients allocated to control group RR = 0.21, 95% CI, 0.07 to 0.66 P = 0.004 To prevent on SSI, triclosan-containing sutures need to be used in 36 children (95% CI, 21 to 111). Wound dehiscence: 4% triclosan group vs. 6% control group (P = 0.14) Wound revision: <1% triclosan group vs. 2% control group (P = 0.016) Additional outpatient physician visits: 4% triclosan group vs. 8% control group (P = 0.004) Readmissions due to SSIs: 1% triclosan group vs. 2% control group (P = 0.01) Antimicrobials because of SSIs: 2% triclosan group vs. 7% control group (P < 0.0001) A per-protocol analysis was conducted based on patients who received the suture type they were randomized to receive (n = 636 in triclosan group; n = 651 in control group) Any SSI: 18/636 (3%) of patients in triclosan group vs. 39/651 (6%) of patients in control group RR = 0.47, 95% CI, 0.27 to 0.801 P = 0.005 Adverse events Suture materials did not reabsorb as expected: 6% triclosan group vs. 6% control group (P = 1.0) One patient (triclosan group) died from suspected mitochondrial disease. No other adverse events were reported.						“Triclosan-containing sutures proved effective in reducing SSIs in this randomized controlled trial in unselected types of surgery in children. The effect seemed to be most prominent in deep SSIs.” (p54) “The overall occurrence of SSIs in our pediatric population was low (around 5%), yet the use of triclosan-containing sutures still reduced their occurrence by 52%. The strengths of this work include the randomized, controlled, and double-blind design, the large sample size, and various types of surgery, which provides more reliable evidence than combining several small studies in a meta-analysis” (p55)
Non-Randomized Studies
Ruiz-Tovar, 2018²⁷
	Vicryl	Vicryl Plus	PDS	PDS Plus	P value	” Triclosan-coated sutures reduce SSI rate in fecal peritonitis with no differences between braided and monofilament ones. The use of monofilament sutures is related to higher risk of evisceration, independent of a triclosan coating.” (p64)
Incisional SSI rate, %	34.6	8	33	10	0.029
Evisceration rate, %	0	0	15.2	10	0.05
Mortality, n	2	2	2	1	NS
Hospital stay, days, median (range)	10 (7 to 37)	7.5 (6 to 26)	9.5 (7 to 64)	8 (5 to 31)	0.044
Risk of SSI: triclosan-coated sutures vs. uncoated sutures RR = 9, 95% CI, 3.1 to 26.4 P = 0.003 Median hospital stay was shorter in patients treated with triclosan-coated sutures (P = 0.013)

: NA = not available; NS = not significant; Post-op = post-operative; RR = risk ratio; SD = standard deviation; SF-12 = Short Form 12; SSI = surgical site infection;

Table 10. Summary of Recommendations in Included Guidelines (PDF, 213K)

Appendix 5. Overlap between Included and Excluded Systematic Reviews

Table 11Primary Study Overlap between Included and Excluded Systematic Reviews

Primary Study Citation		Systematic Review Citation
	Included Reviews		Reviews Excluded due to Overlapping Primary Studies
	EuNetHTA 2017	Konstantelias 2017²⁰	Leaper 2017¹⁸	Onesti 2018	Wu, 2017¹⁷	de Jonge, 2017¹²	Henrikson 2017¹⁴	Guo 2016¹³	Sandini 2016¹⁶	Apisarnthanarak 2015¹⁰	Daoud 2014¹¹
Baracs et al. 2011	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Chen et al. 2011		✕	✕		✕	✕				✕
Diener et al. 2014	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Fleck et al. 2007		✕
Ford et al. 2005		✕	✕		✕	✕				✕	✕
Fraccalvieri et al. 2014		✕	✕
Galal and El-Hindawy 2011		✕	✕	✕	✕	✕		✕		✕	✕
Hoshino et al. 2013		✕	✕		✕					✕
Itatsu et al. 2014		✕
Isik et al. 2012		✕	✕	✕	✕	✕		✕		✕	✕
Jung et al. 2014	✕
Justinger et al. 2013	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Karip et al. 2016		✕	✕
Laas et al. 2012		✕	✕		✕					✕
Mattavelli et al. 2015	✕	✕	✕	✕		✕	✕		✕	✕
Mingmalairak et al. 2009		✕	✕	✕	✕	✕	✕			✕	✕
Nakamura et al. 2013	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Nakamura et al. 2016		✕	✕
Okada et al. 2014	✕		✕		✕					✕
Rasic et al. 2011	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕	✕
Renko et al. 2016^a			✕
Rozzelle et al. 2008		✕	✕	✕		✕				✕	✕
Ruiz-Tovar et al. 2015	✕	✕	✕				✕
Seim et al. 2012		✕	✕	✕	✕	✕		✕		✕	✕
Stadler et al. 2011		✕	✕
Steingrimsson et al. 2015		✕	✕
Thimour-Bergstrom et al. 2013		✕		✕	✕	✕		✕		✕	✕
Turtiainen et al. 2012		✕	✕	✕	✕	✕		✕		✕	✕
Ueno et al. 2015		✕	✕		✕					✕
Williams et al. 2011		✕	✕	✕	✕	✕		✕		✕	✕

a: Early online publication. Finalized version (Renko 2017) captured as a primary study in this report

Appendix 6. Additional References of Potential Interest

Systematic Reviews Excluded due to Overlap

Apisarnthanarak A, Singh N, Bandong AN, Madriaga G. Triclosan-coated sutures reduce the risk of surgical site infections: a systematic review and meta-analysis. Infect Control Hosp Epidemiol. 2015;36(2):169–179. [PubMed: 25632999]
Daoud FC, Edmiston CE, Jr., Leaper D. Meta-analysis of prevention of surgical site infections following incision closure with triclosan-coated sutures: robustness to new evidence. Surg Infect (Larchmt). 2014;15(3):165–181. [PMC free article: PMC4063374] [PubMed: 24738988]
de Jonge SW, Atema JJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2017;104(2):e118–e133. [PubMed: 28093723]
Guo J, Pan LH, Li YX, et al. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials. J Surg Res. 2016;201(1):105–117. [PubMed: 26850191]
Henriksen NA, Deerenberg EB, Venclauskas L, et al. Triclosan-coated sutures and surgical site infection in abdominal surgery: the TRISTAN review, meta-analysis and trial sequential analysis. Hernia. 2017;21(6):833–841. [PubMed: 29043582]
Leaper DJ, Edmiston CE, Jr., Holy CE. Meta-analysis of the potential economic impact following introduction of absorbable antimicrobial sutures. Br J Surg. 2017;104(2):e134–e144. [PubMed: 28093728]
Onesti MG, Carella S, Scuderi N. Effectiveness of antimicrobial-coated sutures for the prevention of surgical site infection: a review of the literature. Eur Rev Med Pharmacol Sci. 2018;22(17):5729–5739. [PubMed: 30229851]
Sandini M, Mattavelli I, Nespoli L, Uggeri F, Gianotti L. Systematic review and meta-analysis of sutures coated with triclosan for the prevention of surgical site infection after elective colorectal surgery according to the PRISMA statement. Medicine (Baltimore). 2016;95(35):e4057. [PMC free article: PMC5008528] [PubMed: 27583844]
Wu X, Kubilay NZ, Ren J, et al. Antimicrobial-coated sutures to decrease surgical site infections: a systematic review and meta-analysis. Eur J Clin Microbiol Infect Dis. 2017;36(1):19–32. [PubMed: 27590620]

About the Series

CADTH Rapid Response Report: Summary with Critical Appraisal

ISSN: 1922-8147

Version: 1.0

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

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Triclosan in single use devices for preventing infections: a review of clinical effectiveness, safety and guidelines. Ottawa: CADTH; 2019 Jul. (CADTH rapid response report: summary with critical appraisal).

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Brett K, Argáez C. Triclosan in Single Use Medical Devices for Preventing Infections: A Review of Clinical Effectiveness, Safety and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jul 11.
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Context and Policy Issues
Research Questions
Key Findings
Methods
Summary of Evidence
Conclusions and Implications for Decision or Policy Making
References
Selection of Included Studies
Characteristics of Included Publications
Critical Appraisal of Included Publications
Main Study Findings and Authors’ Conclusions
Overlap between Included and Excluded Systematic Reviews
Additional References of Potential Interest

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Triclosan in Single Use Medical Devices for Preventing Infections: A Review of Clinical Effectiveness, Safety and Guidelines

Abbreviations

Context and Policy Issues

Research Questions

Key Findings

Methods

Literature Search Methods

Selection Criteria and Methods

Table 1

Exclusion Criteria

Critical Appraisal of Individual Studies

Summary of Evidence

Quantity of Research Available

Summary of Study Characteristics

Study Design

Country of Origin

Patient Population

Interventions and Comparators

Outcomes

Summary of Critical Appraisal

Systematic Reviews and Meta-Analyses

Randomized Controlled Trials

Non-Randomized Study

Guidelines

Summary of Findings

Clinical Effectiveness and Safety of Triclosan on Single use Medical Devices and/or Consumables

SSIs

Wound Dehiscence

Mortality

Length of Stay

Antimicrobial use

Wound Revision

Wound Condition

Evisceration

Additional Outpatient Visits

Readmission

Critical Care Admission

Clostridium Difficile Infections

Pain

Secondary surgery for wound complications

Functional Scores

Quality of Life

Adverse Events

Guidelines

Limitations

Conclusions and Implications for Decision or Policy Making

References

Appendix 1. Selection of Included Studies

Appendix 2. Characteristics of Included Publications

Table 2Characteristics of Included Health Technology Assessments and Systematic Reviews and Meta-Analyses

Table 3Characteristics of Included Primary Clinical Studies

Table 4Characteristics of Included Guidelines

Appendix 3. Critical Appraisal of Included Publications

Table 5Strengths and Limitations of Health Technology Assessments and Systematic Reviews and Meta-Analyses using AMSTAR 26

Table 6Strengths and Limitations of Clinical Studies using the Downs and Black Checklist7

Table 7Strengths and Limitations of Guidelines using AGREE II8

Appendix 4. Main Study Findings and Authors’ Conclusions

Table 8Summary of Findings of the Health Technology Assessment and Systematic Review and Meta-Analysis

Table 9Summary of Findings of Included Primary Clinical Studies

Appendix 5. Overlap between Included and Excluded Systematic Reviews

Table 11Primary Study Overlap between Included and Excluded Systematic Reviews

Appendix 6. Additional References of Potential Interest

Systematic Reviews Excluded due to Overlap

About the Series

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Table 5Strengths and Limitations of Health Technology Assessments and Systematic Reviews and Meta-Analyses using AMSTAR 2⁶

Table 6Strengths and Limitations of Clinical Studies using the Downs and Black Checklist⁷

Table 7Strengths and Limitations of Guidelines using AGREE II⁸