Conflicting results raise concerns

As committed member of the healthcare community, we are dedicated to ensuring that our medical devices meet the highest standards of use

We are concerned about the rise of Surgical Site Infections (SSI) and bacteria resistance in both the community and hospital settings. SSI and the potential for antibiotic resistant bacteria are continuing concerns in healthcare settings.

While currently available recommendations are unanimous in their opinions about some SSI preventive strategies, there is a certain amount of disagreement regarding the benefit of using antimicrobial-coated sutures, particularly Triclosan-Coated Sutures (TCS).

Global Guidance and Recommendations: The story so far.

Authority, year of publication Guidance/recommendation on TCS for SSI prevention
WHO, 20161

Recommends the use of TCS for the purpose of reducing the risk of SSI, independent of the type of surgery.

The WHO rated the strength of its recommendation on TCS as ‘conditional’. The reason for the uncertainty about their TCS recommendation was due to the ‘low to moderate quality of the evidence and the low quality of comparisons in the subgroups of the RCTs included in the meta-regression analyses’.1

SHEA/IDSA, 20142

Do not recommend the routine use of antimicrobial-impregnated sutures as a strategy to prevent SSIs.

The recommendation comments that 'the impact of routine use of antiseptic-impregnated sutures on development of resistance to antiseptics is unknown.'

NICE, 20193

When using sutures, consider using antimicrobial TCS, especially for pediatric surgery, to reduce the risk of SSI.

NICE also identified anti-microbial resistance as a potential harm with increased use of TCS. As TCS are also more expensive, they consider further research with robust study design as essential.

ACS & SIS, 20174

TCS use is recommended for wound closure in clean and clean-contaminated abdominal cases when available.

Recommend TCS use only 'when available' and not as a mandatory measure at all times.

The Uncertainty Continues

  • Triclosan is an antibacterial and antifungal agent.
  • Triclosan is a pesticide.5
  • Mixed reviews on the efficacy to reduce surgical site infections by triclosan impregnated sutures6-15
  • Scientific studies raise potential concerns over the use of triclosan14,16-18 which resulted in consumer products being banned by the FDA15 and some other regulatory agencies19-21
  • Health systems and consumer products companies are phasing out triclosan promoting triclosan-free products21
  • Johnson & Johnson, Ethicon’s parent company, has voluntarily eliminated triclosan from its consumer products by 201522
  • A large body of evidence now exists that indicates substantial uncertainty related to the benefits of anti-infective treated or impregnated devices23 
  • Triclosan resistance: A number of organisms have been found to be resistant to triclosan including Pseudomonas aeruginosa and Staphylococcus aureus and epidermidis, the latter two being common skin organisms and often involved in SSIs.24 
  • Triclosan-induced cross-resistance to other bacteria: A common mechanism for bacteria to resist triclosan is by pumping the chemical out of the cell. The development of such cross-resistance has been demonstrated in a number of important human pathogens (including E. coli 0157) to commonly-used antibiotics.24

A Victory for the FDA

Triclosan is banned by the FDA for OTC consumer antiseptic products25

Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately.” 26 - FDA Commissioner Scott Gottlieb, M.D. 

The FDA bans Triclosan from Antibacterial Hand Soap. “This decision by the FDA is a huge victory on behalf of human health and the environment,” said Ken Cook, co-founder and president of Environmental Working Group (EWG)5

A better solution:

Monofilament Synthetic Absorbable Sutures

Monofilament Synthetic Absorbable Sutures offer a good alternative11,27

Monofilament synthetic absorbable sutures provide less zone of inhibition for microbial colonization.

Monofilament absorbable sutures could be an alternative option to potentially reduce the risk of SSI.Monofilament synthetic absorbable sutures are less prone to bacterial colonization than triclosan impregnated braided sutures.11

Bacterial Colonization - Monofilaments versus braids

An in vitro study shows that monofilament sutures, such as Biosyn™ sutures, have significantly lower levels of bacterial colonization  than either the VICRYL™* Plus or VICRYL™* suture.11

Through reduced surface area and lack of interstitial spaces, monofilament sutures minimize the risk of infection by reducing the ability of bacteria to harbor where they can  multiply.11

Clinical Evidence

Chang et al systematic review and meta analysis

Chang WK, Srinivasa S, Morton R, Hill AG - Triclosan‑impregnated sutures to decrease surgical site infections systematic review and meta‑analysis of randomized trials

Diener et al randomised controlled trial

Diener MK, Knebel P, Kieser M, et al. Germany - Effectiveness of triclosan‑coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial

Sprowson et al double-blind randomized controlled trial

Sprowson AP, Jensen C, Parsons N, Partington P, Emmerson K, Carluke I, Asaad S, Pratt R, Muller S, Ahmed I, Reed MR - 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.

At Medtronic, we believe in Responsible Utilization:

We are focused on ensuring that the right technology and approach are used in the right procedure.

Our product development philosophy is based on delivering in three key areas: Alleviate Pain, Restore Health and Extend Life.

Medtronic sutures will remain 100% triclosan free until there is more conclusive evidence on triclosan without potential risks.

OR ESSENTIALS

The Complete Solution You Can Trust

We pride ourselves on being a brand you can trust. With our proven track record of quality products and services, you can feel reassured that Medtronic’s OR Essentials will help you to continue providing the very best patient care from the first mark to the last stitch.

  • 1. World Health Organisation (WHO). Global guidelines for the prevention of surgical site infections. Published by WHO, November 2016. Available at: www.who.int/gpsc/ssi-prevention-guidelines/en [Accessed 12/12/16]

  • 2. Anderson DJ, Podgorny K, Berríos-Torres SI et al. SHEA/IDSA Practice Recommendation. Strategies to prevent surgical site infections in acute care hospitals: 2014 Update Infect Control Hosp Epidemiol 2014;35(s2): 605–27

  • 3. NICE Evidence update NG125 (April 2019). Available at: https://www.nice.org.uk/guidance [Accessed 22/05/19]

  • 4. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg 2017;224:59-74

  • 5. FDA finally Bans Toxic Triclosan from antibacterial hand soaps, Sept 2016, https://www.ewg.org/release/fda-finally-bans-toxic-triclosan-antibacterial-hand-soaps. Accessed Jan. 2018

  • 6. Chang WK, Srinivasa S, Morton R, Hill AG. Triclosan-Impregnated Sutures to Decrease Surgical Site Infections-Systematic Review and Meta-Analysis of Randomized Trial. Ann Surg. 2012;255(5):854-859. doi: 10.1097/SLA.0b013e31824e7005.

  • 7. Deliaert AE, Van den Kerckhove E, Tuinder S, et al. The effect of Triclosan-coated sutures in wound healing. A double blind randomised prospective pilot study.J Plast Reconstr Aesthet Surg. 2008. doi:10.1016/j.bjps.2007.10.075.

  • 8. Turtiainen J, Saimanen E, Makinen K, et al. Effect of Triclosan-Coated Sutures on the Incidence of Surgical Wound Infection After Lower Limb Revascularization Surgery: A Randomized Controlled Trial). World J. Surg. 2012;36(10):2528-2534. doi: 10.1007/s00268-012-1655-4.

  • 9. Seim BJ, Tonnessen T, Woldbaek PR. Triclosan-coated sutures do not reduce leg wound infections after coronary artery bypass grafting. Interact CardioVasc Thorac Surg. 2012;15 (3):415. doi: 10.1093/icvts/ivs266.

  • 10. Isik I, Selimen D, Senay S, AlhanC. Efficiency of Antibacterial Suture Material in Cardiac Surgery: A Double-blind Randomized Prospective Study. The Heart Surgery Forum,. Volume 15( 1).2012;E40 - E45. doi: 10.1532/HSF98.20111106.

  • 11. Stopek J, Migliozi J, Cai C, et al. Bacterial Colonization of Suture Biomaterials with Varied Substrate Architecture and Chemistry. Presented at the Society of Biomaterials. 2007.

  • 12. Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, et al. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial. Eur J Cardiothorac Surg. 2013; 44 (5): 931-938. doi: 10.1093/ejcts/ezt063.

  • 13. Wang ZX, Jiang CP, Cao Y, Ding YT. Systematic review and meta-analysis of triclosan-coated sutures for the prevention of surgical-site infection. British Journal of Surgery. 2013. Volume 100, Issue 4, pages 465–473. doi: 10.1002/bjs.9062.

  • 14. Edmiston CE, Daoud FC, Leaper D. 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. Volume 154, Issue 1, Pages 89-100.

  • 15. de Jonge SW, AtemaJJ, Solomkin JS, Boermeester MA. Meta-analysis and trial sequential analysis of triclosan-coated sutures for the prevention of surgical-site infection. BJS Society Ltd. 2016. doi: 10.1002/bjs.10445.

  • 16. Schweizer, HP. A widely used biocide and its link to antibiotics. FEMS Microbiology Letters. 2001. Volume 202, Issue 1, pages 1–7. doi: 10.1111/j.1574-6968.2001.tb10772.x.

  • 17. Brenwald, NP, Fraise, AP. Triclosan resistance in methicillin-resistant Staphylococcus aureus (MRSA). Journal of Hospital Infection. 2003.Volume 55, Issue 2, Pages 141–144.

  • 18. Levy, SB. Antibacterial Household Products: Cause for Concern. Emerg Infect Dis. 2001.7(3 Suppl): 512–515

  • 19. Environmental and Climate Change Canada. http://ec.gc.ca/ese-ees/default.asp?lang=En&n=371A2F3C-1. Updated Nov.25,2016.Last access Nov.2017

  • 20. Public Health Triclosan and Antibiotics Restriction http://ec.europa.eu/health/scientific_committees/opinions_layman/triclosan/en/l-3/2-uses-cosmeticsdisinfectant.htm Last access Mar.2018.

  • 21. Beyond Pesticides, https://beyondpesticides.org/programs/antibacterials/triclosan , Accessed Jun.2018

  • 22. Johnson and Johnson to phase out triclosan, Regulators remain unresponsive, https://beyondpesticides.org/dailynewsblog/2012/08/  johnson-and-johnson-to-phase-out-triclosan-regulators-remain-unresponsive/,  Accessed  May 2018

  • 23. Sedrakyan Art. Comment on Diener Study: Precarious innovation of anti-infective coated devices. 2014

  • 24. Saleh S, Haddadin RNS, Baillie S, Collier PJ. Triclosan – an update. Letters in Applied Microbiology 2010; 52: 87-95

  • 25. FDA Safety and Effectiveness of Consumer Antiseptics. Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 09/06/2016 https://www.federalregister.gov/documents/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antisepticstopical-antimicrobial-drug-products-for.Published Jun.9, 2016. Last access Mar.2018.

  • 26. The Cancer Prevention & Education Society, page 22, http://webcache.googleusercontent.com/search?q=cache:qHQQgnM4UwAJ:www.inges.at/silbertagung/Page%%2520Wien%25209-6-2011.pdf+&cd=4&hl=en&ct=clnk . Accessed Jan.12, 2018 

  • 27. Covidien Internal report. In Vitro Evaluation of Staphylococcus aureus of commercial Braided Synthetic Absorbable (BSA) suture materials (some  containing Triclosan) and Monofilament Synthetic Absorbable (MSA) sutures; P value <0.05