Draft revised Australian Guidelines for the Prevention and Control of Infection in Healthcare submission

ID:

Personal Details

This submission reflects the views of

Organisation Name:

Johnson & Johnson Medical Pty Ltd

Specific Questions

1. Introduction:

Johnson & Johnson (J&J) is the world’s most comprehensive and broadly-based healthcare company. In Australia, our Family of Companies consists of:

• Johnson & Johnson Pacific Pty Ltd, known for its portfolio of leading consumer health brands

• Johnson & Johnson Medical Pty Ltd, our medical devices business

• Janssen, our pharmaceutical companies

We provide Australians access to innovative medical technology and solutions across a variety of conditions; offering a unique perspective on ways in which our Australian health system can be enhanced to improve care for patients. Johnson & Johnson Medical Pty Ltd (JJM) is an operating company of J&J that develops and supplies innovative products and solutions used primarily by health care professionals in the fields of general and plastic surgery, orthopaedics, neurology, bariatric surgery, infection prevention, urology, gynaecology, sports medicine and cardiovascular disease.

JJM has a long history of expertise in helping healthcare providers address risk for infections, starting in 1887 with the mass production of sterile sutures. Today, our portfolio includes innovative wound closure solutions, such as Triclosan-Coated Sutures (TCS), to address a risk factor associated with Surgical Site Infections (SSIs) and advanced sterilisation technologies to meet health systems’ needs burdened by Healthcare Associated Infections (HAIs). We are committed to identifying solutions to reduce the risk of infection for patients receiving care through an evidence based approach whilst providing surgical training and healthcare professional education programs to help promote a culture of infection control and prevention.

The need to address infection risk is an increasing priority for the Australian health system and JJM welcomes the National Health & Medical Research Council’s (NHMRC) consultations on the draft revised Australian Guidelines for the Prevention and Control of Infection in Healthcare.

We would welcome your consideration of our recommendations and agreements in the following sections within the guidelines:

Section 3.4.3.1 Preventing Surgical Site Infections, Table 20 Summary of intraoperative processes

TCS are the only antibacterial sutures that have been evaluated in multiple independent studies for their clinical and economic outcomes. Reflective of the current and evolving evidence base on TCS, we recommend NHMRC to consider updating the currently drafted guideline referring to the use of antimicrobial-coated sutures to “The use of Triclosan-Coated Sutures help in reducing SSI rates” [liii liv lv]. By doing so, NHMRC’s guidelines will reflect the latest international move in the prevention of SSIs, with the evidence based goal of improving patient outcomes and unlocking potential savings that TCS can deliver to Australian patients and healthcare facilities respectively.

We acknowledge NHMRC for considering dressings for surgical incisions at the end of an operation as reflected in the draft guidelines showing “It is recommended that at the end of the operation, surgical incisions are covered with an appropriate dressing such as semi-permeable film membrane with or without an absorbent island”. JJM encourages NHMRC to incorporate Topical Skin Adhesives (TSAs) to the above statement based on significant advances of TSAs. They have been FDA approved from 1998 [lviii] and have been registered with the Therapeutic Goods Administration from 2010 i. TSAs provide a microbial barrier with 99% protection in vitro for 72 hours against organisms commonly responsible for SSIs; making them suitable for immediate closure at the end of a surgical procedure [lix]. Several peer-reviewed scientific publications show that TSAs offer advantages to surgeons, healthcare system providers and patients compared to conventional surgical wound closure techniques such as sutures or staples. TSAs offer multiple benefits recognised from published evidence including faster closure time, non-invasive, less tissue trauma, ease of bathing and elimination of secondary dressing [ii lviii lix]. Additionally, TSAs naturally fall off the skin in a short period of time (5–10 days), thereby not requiring clinician or allied health (nursing) removal [iv]. These unique benefits have resulted in a significant increase in both the real-world use and acceptance of TSAs not just globally, but also in Australia as reflected in the clinical practice procedure guidelines [v] from the Queensland [vi] and New South Wales [vii] State Department of Health. We recommend NHMRC to update the statement as below:

“It is recommended that at the end of the operation, surgical incisions are covered with an appropriate dressing such as semi-permeable film membrane with or without an absorbent island or a Topical Skin Adhesive”

Section 3.1.6 Reprocessing of reusable instruments and equipment

We highly support NHMRCs update to Section 3.1.6 on Reprocessing of reusable instruments and equipment’s under Sterilisation to include “Reprocessing heat and moisture-sensitive items requires use of a low-temperature sterilisation technology (e.g. ethylene oxide, hydrogen peroxide plasma, peracetic acid, aldehyde”. Low temperature sterilisation (LTS) provides a Sterility Assurance Level of 10-6 and has been shown to reduce damage and repair to heat and moisture sensitive medical instruments, compared to steam autoclaves. The economic benefits of LTS have been modelled in peer-reviewed publication with the latest study showing 6% internal rate of return for investing in LTS equipment [lxvii].

2. Basics of infection prevention and control:

2.1 Reducing surgical site infection

2.1.1 Burden of surgical site infections in Australia

SSIs are a subset of HAIs that can occur after an invasive surgical procedure and is specifically related to the surgical site. SSIs are a major source of postoperative illness and comprise approximately 4.7% of HAIs [viii]. Reported rates vary according to surgical procedure; spanning for some procedures 3% [ix] and up to 30% [x xi xii] in some colorectal procedures.

SSI represents a substantial burden on the healthcare system and patients, mainly attributable to the increased hospital expenditure, morbidity and mortality. The Australian Commission on Safety and Quality in Healthcare reported that patients with SSI are estimated to spend an additional 14.39 days [xiii] in hospital, which, based on the national average cost per hospital day of $2,003 [xiv], results in an estimated average cost of $28,823 for a single SSI occurrence. The additional length of stay associated with SSIs varies by procedure and patient characteristics. An Australian study by Boardman et al in 2005 estimated the additional excess cost of SSI for hip and knee replacement to be AU$34,138 and AU$40,940, respectively [xv].

2.1.2 Unmet Need

There is substantial clinical and economic burden associated with SSIs:

Patients who develop an SSI have a 2 to 11-fold higher mortality rate than patients who do not develop SSI [xvi]
SSIs are a major source of postoperative illness and comprise approximately 4.7% of HAIs [viii] and are associated with an additional 14.39 [xiii] postoperative hospital days per patient, which consumes healthcare resources including hospital beds
There are no global or Australian studies that evaluate the overall economic burden of SSIs to the Australian health care system and the indirect costs of SSI from a societal perspective. We assume this is due to Australia being one of the few Organisation for Economic Co-operation and Development countries that does not undertake national SSI point prevalence studies, or have a national surveillance program pertinent to SSI. A comprehensive study by Leaper et al showed that the economic burden of SSIs in Europe was between €1.47-19.1 billion and suggested that the true cost of SSI is likely to be underestimated due to incomplete reporting of infection rates [x viii xvii]. SSIs have been shown to account for up to $10 billion annually in the US.

The chance of acquiring SSIs is associated with a range of uncontrollable and controllable risk factors. Sutures act as a foreign body in the wound tissue and lower the number of bacteria required to trigger infection. It has been shown that SSIs can occur in any surgical procedure and it takes 10,000x fewer bacteria to develop an SSI when a foreign body is present [xix xx]. The choice of suture material has a profound effect on the risk of SSIs after surgical interventions and is one element of surgery that can be targeted with novel approaches to prevention of infection. Antibacterial sutures have been proven to reduce the risk of SSI.

2.3 Triclosan-Coated Sutures reduce Surgical Site Infections

Micro-organisms colonise the suture as it is implanted, potentially developing a biofilm [xxi], which may subsequently establish immunity to both systemic and local antimicrobial treatment. Any broad-spectrum local antibacterial agent used should have an established safety profile that does not interfere with the suture material. Triclosan is an established agent that has been effectively used in consumer products for more than 40 years for its antiseptic and antibacterial properties [xxii]. In vitro studies have shown that TCS create an ‘active zone’ around the suture, inhibiting Staphylococcus aureus, Staphylococcus epidermidis and methicillin-resistant strains of Staphylococcus (MRSA and MRSE), the leading bacteria at the site of surgery, from colonising on the suture for a minimum of 48 hours [xxii xxiv xxv].

As one of the leading international manufacturer of sutures, JJM is committed to investing in technology aimed at decreasing the risk of colonisation of suture material. JJM’s Plus® sutures [xxvi] are the only globally available sutures coated with IRGACARE® MP (one of the purest forms of antibacterial agents called Triclosan).

TCS are the only anti-bacterial sutures that have been successfully evaluated to be accepted into international guidelines due to multiple independent studies for their clinical and economic outcomes. Refer Figure 1. The evidence comes from meta-analyses published between 2012 and 2017, eighty three percent of which showed a significant reduction in the rate of SSI (24%-84%) with TCS compared to non-coated sutures [xvii xxvii xxviii xxix xxx xxxi xxxii xxxiii xxxiv xxxvi xxxvii]. De Jonge et al (2017) conducted a meta-analysis including 21 RCTs using the Grading of Recommendations Assessment, Development and Evaluation methodology to assess the quality of evidence and concluded that TCS are effective in reducing SSI (RR=0.72; P<0.001) [xxviii]. A 2017 systematic review and meta-analysis including 34 studies (20 of which were randomised) concluded that TCS may result in significant savings across various surgical wound types, and authors recommended that TCS be considered for superficial and deep layer closure after all surgical operations [xvii]. Appendix 2 summarises the above mentioned meta-analyses and systematic reviews (attached in email).

Figure 1. Clinical and economic consequences of using triclosan containing sutures vs. non-coated sutures (Appendix 3 attached in an email)

Randomised Controlled Trials (RCTs), in addition to the above meta-analyses, have demonstrated that TCS are an impactful and effective solution to address the risk of SSIs compared to other methods that can be implemented in the healthcare setting. TCS have antiseptic and antibacterial properties that carry little risk of microbial resistance because their rapid, direct, and disruptive action is on multiple, non-specific sites of microbial cell biology [xxxviii].(Appendix 2 provides a summary of referenced RCTs attached in email)

A JJM Heath Economics Market Access literature search critically analysing evidence on TCS was completed on 10th May. The search included RCTs comparing TCS to non-coated sutures published from 2011 to 2018 with SSI as the primary end point. 8 of the 14 identified RCTs indicated a significant reduction in SSI (43% – 80%) with TCS [xxxi xxxix xl xli xlii xliii xliv xlv xlvi xlvii xlviii xlix l li]

Galal et al (2011) showed that SSI incidence was more than doubled when non-coated sutures were used, as a result of each SSI incidence the mean extended post-operative days was 3.71 [li], contributing a median additional cost of $2,310 for wound infection management [xlv]. Therefore, the potential for TCS to address a controllable risk factor in the occurrence of SSIs is noteworthy and economically beneficial.

Recommendation 1

NHMRC’s initiative to include antimicrobial-coated sutures as a consideration during the intraoperative process recognises the role these provide in addressing the risk of SSIs. Based on the latest proven clinical and economic evidence associated with TCS, we recommend NHMRC consider updating currently drafted guideline referring to the use of antimicrobial-coated sutures to “The use of Triclosan-Coated Sutures help in reducing SSI rates”. By doing so, NHMRC’s guidelines will reflect the latest international move in the prevention of SSIs, with an evidence based goal of improving patient outcomes and unlocking potential savings that TCS can deliver to Australian patients and healthcare facilities respectively.

2.4 Health Technology Assessments/Policy/Guidelines on TCS

The potential for TCS to address a controllable risk factor in the occurrence of SSIs has been evidenced in a significant number of robust clinical studies. This potential has been increasingly recognised internationally with the following instances of guidelines specifically recommending the use of TCS.

World Health Organisation

In November 2016, the World Health Organization (WHO) released Global guidelines on the prevention of SSI and “suggests the use of Triclosan-Coated Sutures to reduce the risk of SSIs, independent of the type of surgery” [lii]

Centers for Disease Control and Prevention (CDC)

In 2017, the CDC revised its Guideline for the Prevention of SSI to “Consider use of Triclosan-Coated Sutures for the prevention of SSI” [liii]

American College of Surgeons and Surgical Infection Society

In December 2016, the American College of Surgeons and Surgical Infection Society also released guidelines recommending surgeons to use Triclosan-Coated Sutures “for wound closure in clean and clean-contaminated abdominal cases when available” to reduce the risk of SSI [liv]

Canadian Agency for Drugs and Technologies in Health (CADTH)

The CADTH published a Rapid Response Report in 2013 to review the clinical effectiveness, safety, guidelines and cost-effectiveness of antimicrobial sutures for wound closure after surgery. The report concluded that randomized controlled trials of Triclosan-containing sutures compared to non-Triclosan containing sutures have shown benefits in terms of reduced SSIs [lv]

European Network for Health Technology Assessment (EUnetHTA)

EUnetHTA undertook a systematic review and meta-analysis to evaluate antibacterial-coated sutures versus non-antibacterial-coated sutures for the prevention of abdominal, superficial and deep incisional SSI. A statistically significant benefit of TCS in reducing the risk of total incisional SSIs was demonstrated [lvi].

Recently, the National Health Services (NHS) England recognised JJM Plus® Sutures (TCS) among one of the four innovative products from a total of two-hundred and fifty put forward, to be funded as part of the Innovation and Technology Payment for 2018/19 to improve patient access to the benefit of Plus® sutures [lvii].

2.5 Budget impact of triclosan-containing sutures: published estimates

A number of studies have evaluated the budget impact of using TCS compared with non-coated sutures to hospitals. To provide a perspective from the published literature, a meta-analysis by Leaper et al (2017) reported average savings from using TCS of £91.25 per procedure across all wound types with TCS [xvii].

Estimated costs of SSI differ widely and the overall economic impact of SSI is not well addressed in Australia. The Australian Commission on Safety and Quality in Healthcare reported that SSIs are estimated to cause an additional 14.39 [xiii] days in hospital, which, based on the national average cost per hospital day of $2,003 [xiv] results in an estimated average cost of $28,823 for a single SSI occurrence. A hospital carrying out 200 colorectal procedures over a 12-month period with an average SSI rate of 6%, could generate efficiency savings of AU $116,670 by a conversion to TCS, applying a 30% relative risk reduction in SSI.

2.2 Topical Skin Adhesive for surgical site closure

TSAs are indicated to approximate skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery to trauma induced lacerations [i]. They have been FDA approved from 1998 [lviii] and have been registered with the Therapeutic Goods Administration from 2010 [i].

One of the many benefits of TSAs include obviating the need for removal of sutures or a skin closing device. In addition, TSAs can be applied more rapidly, making wound care more accessible by serving as one individual dressing and, have demonstrated to be more cost-effective than traditional methods of skin closure [lix]. TSAs provide a microbial barrier with 99% protection in vitro for 72 hours against organisms commonly responsible for SSIs; making them suitable for immediate closure at the end of a surgical procedure lx. Other benefits of TSA are the even distribution of tension across the length of the incision

to ensure wound edge approximation throughout the wound-healing process [lxi]. Furthermore, it reduces subcuticular closure time compared to subcuticular suturing [lvi].

Recommendation 2

Several peer-reviewed scientific publications state that TSAs offer advantages to surgeons, healthcare system providers, and patients compared to conventional surgical wound closure such as sutures or staples. TSAs offer multiple benefits recognised from published evidence including faster closure time, non-invasive, less tissue trauma, ease of bathing and elimination of secondary dressing [ii]. Additionally, TSAs naturally fall off the skin in a short time period of time (5–10 days), thereby not requiring clinician removal [iii]. These unique benefits have resulted in a significant increase in both the real-world use and acceptance of TSAs not just globally, but also in Australia as reflected in the clinical practice procedure guidelines v from the Queensland vi and New South Wales [vii] State Department of Health. We recommend NHMRC to update the statement as below:

2.3 Low Temperature Sterilisation (LTS) technology for reprocessing heat and moisture sensitive instruments

Moist heat in the form of saturated steam under pressure is the most widely used sterilisation method. Steam sterilisation has been documented in published evidence to have deleterious effects on some materials such as corrosion and combustion of lubricants associated with dental handpieces [lxiii]; reduction in ability to transmit light associated with laryngoscopess [lxiv] and increased repair for heat and moisture sensitive instruments such as rigid and flexible endoscope [lxiv].

The last decade has seen an increase in the number of endoscopic procedures and as per the Australian Institute of Health & Welfare’s report, 40% of hospitalisations relating to the digestive system involved an endoscopy [lxv]. The demand for endoscopic procedures are expected to grow further due to our ageing population vulnerable to bowel, stomach and oesophageal cancer; population growth and national screening programs [lxvi].

LTS provide a Sterility Assurance Level of 10^-6 and has been shown to do less damage to medical instruments than steam autoclaves [lxvii]. McCreanor et al (2017) estimated the number of repairs per instruments sterilised by steam to be 0.0032 [xli] with average cost of endoscope repair at AU $2237.54. For a medium sized hospital performing 85 endoscopic procedures per week, the annual cost of endoscope repair from steam sterilisation is calculated at $58,913. Skogas et al (2003) showed a 58% reduction in risk [lxiv] of damage per endoscope per sterilisation with LTS which translates to annual cost saving of $34,170.

Notably and reflective of the evidence [lxviii lxix lxx lxxi lxxii lxxiii lxxiv lxxv lxxvi lxxvii lxxviii lxxix] CDC Guideline for Disinfection and Sterilisation in Healthcare Facilities (2008) [lxxxi] in the US endorses use of LTS technologies (e.g., EtO, hydrogen peroxide gas plasma) for reprocessing critical patient-care equipment that is heat or moisture sensitive with Category IA recommendation (strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies).

We support NHMRCs update to Section 3.1.6 on Reprocessing of reusable instruments and equipment’s under Sterilisation to include “Reprocessing heat and moisture-sensitive items requires use of a low-temperature sterilisation technology (e.g. ethylene oxide, hydrogen peroxide plasma, peracetic acid, aldehyde)”.

References are attached as Appendix 1.

3. Standard and transmission-based precautions:

N/A

4. Organisational support:

Our Australian Story

When Johnson & Johnson first arrived in Australia in 1931, the life expectancy for a male born that year was around 63 years, while the expected span for a female was about 67 years.

Today the story is radically different, with recent estimates from the Australian Institute of Health and Welfare showing that compared to their counterparts in the early 20^th century, babies born in 2013-14 can live around 15-20 years longer. There is no doubt the huge advances in health and medical care have played a massive part in that increase, and we’d like to think that Johnson & Johnson has had a crucial role in this extraordinary improvement.

We also like to think that since 1931 we have played a role in the economic health of Australia. We currently employ almost 1300 people throughout Australia across our Family of Companies, with those valued employees being an integral part of the many communities – small and large – that they inhabit.

We work across eight of the NHMRCs strategic priorities designated by the Australian government’s nine National Health Priority Areas (NHPAs)[lxxx], chosen because they contribute significantly to the disease and illness burden in the community. We are constantly looking to improve the solutions we offer, across a broad range of fields such as cancer, obesity, orthopaedics, neurological disease, vision care, diabetes care, infection prevention, and diagnostics through to treating Australia’s biggest killer - cardiovascular disease.

Our Credo

We believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to reduce our costs in order to maintain reasonable prices. Customers’ orders must be serviced promptly and accurately. Our suppliers and distributors must have an opportunity to make a fair profit.

We are responsible to our employees, the men, and women who work with us throughout the world. Everyone must be considered as an individual. We must respect their dignity and recognise their merit. They must have a sense of security in their jobs. Compensation must be fair and adequate, and working conditions clean, orderly and safe. We must be mindful of ways to help our employees fulfill their family responsibilities. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development, and advancement for those qualified. We must provide competent management, and their actions must be just and ethical.

We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use, protecting the environment and natural resources.

Our final responsibility is to our stockholders. Business must make a sound profit. We must experiment with new ideas. Research must be carried on, innovative programs developed and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times.

Our Commitment

As one of the leading supplier of medical devices and technology, Johnson & Johnson Medical Pty Ltd (JJM) is driven by a commitment to patients. We develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders and investing in entrepreneurial leadership.

We collaborate with industry associations, alliances, health forums, national organisations, advocacy groups and policymakers to ensure our healthcare system provides patients with timely access to medical technologies that improve lives.

We are a significant supplier of professional education to the Australian healthcare professionals who use our innovative products and solutions. Every year we provide training to more than 4000 healthcare professionals and offering more than 200 educational grants across Australia. Our partnership with universities addresses emerging issues across the Australian health landscape by providing joint education and research programs, practical experience to student, doctors, nurses through to registrars and consultants.

Our emphasis on value is combined with a relentless focus on product quality, safety, and continuous improvement - in meeting our customer needs everything we do must be of high quality’ reads Our Credo. We explore new ways to continue fostering our proactive quality culture and use evidence-based expertise to engage in leadership roles with external stakeholders for collaboration on future regulations.

Our vision is straightforward: to positively impact human health through innovation. For this, we develop the best science and technology in order to solve the greatest needs of our time based on evidence. We also encourage, support and invest in the early-stage research and discovery that is the essential first step to making the life-changing products that our business is founded upon. We believe that people have the right to long and healthy lives and explore every possible avenue in pursuit of this goal.

5. Appendix 1:

References

[i] Dermabond®, ARTG 17153 - Johnson & Johnson Medical Pty Ltd - Adhesive, soft tissue approximation.

[ii] Chow et al (2010). Use of tissue glue for surgical incision closure: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Surg. 2010;211:114–125. doi: 10.1016/j.jamcollsurg.2010.03.013.

[iii] Scott et al (2007). Dermabond skin closures for bilateral reduction mammaplasties: a review of 255 consecutive cases. Plast Reconstr Surg. 2007 Nov;120(6):1460-5.

[iv] Tajirian et al (2010). A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010;12:296–302. doi: 10.3109/14764172.2010.538413.

[v] The Royal Children's Hospital Melbourne (2017). Clinical Practice Guidelines for Lacerations. Available online at https://www.rch.org.au/clinicalguide/guideline_index/Lacerations/. Accessed on 11th May 2018.

viQueensland Government, Department of Health (2017). Clinical practice procedures-Trauma/Skin closure - Histoacryl® topical skin adhesive. Available online at https://www.ambulance.qld.gov.au/docs/clinical/cpp/CPP_Skin%20glue.pdf. Accessed on 11th May 2018.

[vii] New South Wales Government, Department of Health (2012). Policy statement on Topical Skin Adhesives – Administration by accredited emergency nurses for the management of acute lacerations. Available online at https://www.cena.org.au/wp-content/uploads/2016/12/SESLHD-EDSTO-Dermal-A.... Accessed on 11th May 2018.

[viii] Mitchell et al (2017). The burden of healthcare-associated infection in Australian hospitals: A systematic review of the literature. Infection, Disease & Health (2017) 22, 117e128. SSI incidence estimated by dividing occurrence of SSI 3946 by total HAI occurrence 83096.

[ix] Australian Commission on Safety and Quality in Healthcare (2017). Approaches to Surgical Site Infection Surveillance. Available online at https://www.safetyandquality.gov.au/wp-content/uploads/2017/07/Approache.... Accessed on 1st May 2018.

[x] Edwards et al (2008). National Healthcare Safety Network (NHSN) Report, data summary for 2006 through 2007, issued November 2008. Am J Infect Control 2008;36:609–626.

[xi] Itani et al (2006). Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med 2006;355:2640–2651.

[xii] Sergeant et al (2008). Incisional surgical site infections after colorectal surgery: time to appraise its true incidence. Acta Chir Belg 2008;108:513–517.

[xiii] KPMG report commissioned by the Australian Commission on Safety and Quality in Healthcare (2013). Available online at

https://www.safetyandquality.gov.au/wp-content/uploads/2014/06/National-set-of-high-priority-hospital-complications-Dec-2013.pdf. Accessed on 1st May 2018.

[xiv] Independent Hospital Pricing Authority, National Hospital Cost Data Collection Cost Report: Round 20 Financial Year 2015-16. Available online at https://www.ihpa.gov.au/sites/g/files/net4186/f/publications/nhcdc_cost_.... Accessed on 1st May 2018. National average cost per hospital day of $2003.

[xv] Boardman et al (2005). Oral presentation: the VICNISS Costing Study of Infections Associated with Selected Orthopaedic Procedures (ARCHI). Australian Resource Centre for Healthcare Innovations Seminar. Brisbane, Australia, 2005.

[xvi] Awad et al (2012)"Adherence to surgical care improvement project measures and postoperative surgical site infections". Surgical Infection (Larchmt), 13(4): (2012): 234-7.

[xvii] Leaper et al (2017). Meta-analysis of the potential economic impact following introduction of absorbable antimicrobial sutures. BJS 2017; 104: e134–e144.

[xviii] Anderson et al (2008) Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol 2008;29 Suppl 1:S51-61.

[xix] Elek et al (1957). The Virulence of Staphylococcus Pyogenes for Man. A Study of the Problems of Wound Infection. J Exp Pathol. 1957;38:573_86.

[xx] Kathju et al (2009). Chronic surgical site infection due to suture-associated polymicrobial biofilm. Surg Infect (Larchmt). 2009;10(5):457_461.

[xxi] Sulamanidze et al (2007). Evaluation of a novel technique for wound closure using a barbed suture. Plast Reconstr Surg 2007;120:349–350.

[xxii] Rodricks et al (2010). Triclosan: a critical review of the experimental data and development of margins of safety for consumer products. Crit Rev Toxicol. 2010 May;40(5):422-84.

[xxiii] Barbolt et al (2002). Chemistry and safety of triclosan, and its use as an antimicrobial coating on coated vicryl* plus antibacterial suture (coated polyglactin 910 suture with triclosan). Surg Infect (Larchmt) 2002;3(Suppl 1):S45–S53.

[xxiv] Rothenburger et al(2002). In vitro antimicrobial evaluation of coated vicryl* plus antibacterial suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt) 2002;3(Suppl 1):S79–S87

[xxv] Storch ML et al (2004). Experimental efficacy study of coated vicryl plus antibacterial suture in guinea pigs challenged with Staphylococcus aureus. Surg Infect (Larchmt) 2004;5:281–288.

[xxvi] Vicryl Plus, Monocryl Plus, PDS Plus, Stratafix Spiral, Monocryl Plus, Stratafix Spiral PDS Plus and Stratafix Symmetric PDS Plus IFUs.

[xxvii] Henriksen et al (2017). Triclosan‑coated sutures and surgical site infection in abdominal surgery: the TRISTAN review, meta‑analysis and trial sequential Analysis. Hernia (2017) 21:833–841.

[xxviii] De Jonge et al (2017). Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. British Journal of Surgery. 2017;104: e118-e133.

[xxix] Wu et al (2016). Antimicrobial-coated sutures to decrease surgical site infections: a systematic review and meta-analysis. Eur J Clin Microbiol Infect Dis. 2017 Jan;36(1):19-32.

[xxx] Sandini et al (2016). 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 (2016) 95:35.

[xxxi] Guo et al (2016). 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 Mar;201(1):105-175.

[xxxii] Apisarnthanrak et al (2015). Triclosan-coated sutures reduce the risk of surgical site infections: a systematic review and meta-analysis. Infect Control Hosp Epidemiol. 2015 Feb;36(2):169-79.

[xxxiii] Daoud et al (2014). Meta-Analysis of Prevention of Surgical Site Infections following Incision Closure with Triclosan-Coated Sutures: Robustness to New Evidence. Surg Infect (Larchmt). 2014 Jun 1; 15(3): 165–181.

[xxxiv] Edmiston et al (2013). Is there an evidence-based argument for embracing an antimicrobial (triclosan)-coated suture technology to reduce the risk for surgical-site infections?: A meta-analysis. Surgery. 2013 Jul;154(1):89-100.

[xxxv] Sajid et al (2013). Use of antibacterial sutures for skin closure in controlling surgical site infections: a systematic review of published randomized, controlled trials. Gastroenterol Rep (Oxf). 2013 Jul; 1(1): 42–50.

[xxxvi] Wang et al (2013). Systematic review and meta-analysis of triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2013 Mar;100(4):465-73.

[xxxvii] Chang et al (2012). Triclosan-Impregnated Sutures to Decrease Surgical Site Infections: Systematic Review and Meta-Analysis of Randomized Trials. Ann Surg. 2012; 255(5): 854-9.40.

[xxxviii] Ruiz-Tovar J et al (2015) Association between Triclosan-Coated Sutures for Abdominal Wall Closure and Incisional Surgical Site Infection after Open Surgery in Patients Presenting with Fecal Peritonitis: A Randomized Clinical Trial. Surg Infect (Larchmt). 2015 Oct;16(5):588-94.

[xxxix] Ichida K. et al (2018) 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.

[xl] Sprowson et al (2018) 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 Mar 1;100-B(3):296-302.

[xli] Golub et al (2016) Surgical Site Infections after Open Appendectomy and Effectiveness of Complex Approach to Their Prevention. Khirurgiia (Mosk). 2016;(6):68-76.

[xlii] Renko et al (2016) Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: a double-blind, randomised controlled trial. Lancet Infect Dis. 2017 Jan;17(1):50-57.

[xliii] Mattavelli et al (2015) Multi-Center Randomized Controlled Trial on the Effect of Triclosan-Coated Sutures on Surgical Site Infection after Colorectal Surgery. Surg Infect (Larchmt). 2015 Jun;16(3):226-35.

[xliv] Steingrimsson et al (2015) Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial. Eur J Clin Microbiol Infect Dis. 2015 Dec;34(12):2331-8.

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6. Appendix 2:

Attached in email

7. Appendix 3 :

Attached in email

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