Health care-acquired infections (HCAI) affect hundreds of millions of patients worldwide each year. At the hospital level in Europe alone, the European Centre for Disease Prevention and Control reports 7.1% as the average prevalence rate of hospital-acquired infections (HAI), meaning that over 4.5 million people per year suffer from an infection they acquired in a health care setting. Despite years of advancements in the delivery of health care, HAIs still remain a major burden for patients, hospitals and health care systems.
Surgical site infections (SSIs) present a big problem in health care – orthopaedics in particular
Over one-third of cases with an HAI present at the time of admission are due to SSIs, which occur in the part of the body where the surgery took place – typically within 30 days after surgeries not involving an implant, or within one year in cases involving the placement of an implant when the infection appears to be surgery-related. A patient with an SSI is more than five times as likely to be readmitted to the hospital post-discharge, sixty percent more likely to visit the ICU, and even more alarmingly, twice as likely to die.
Patients that developed infection had 76% higher total direct costs than patients without infection (UK data). At a macro level in the EU, nosocomial infections cause approximately 16 million extra days of hospital stays, while creating additional hard costs of about 7 billion euros per year.
This is a huge burden, yet medical experts estimate that up to 60% of SSIs may be preventable.
Johnson & Johnson has always focused on fighting the risk of infection
For more than 130 years, Johnson & Johnson has focused significant energy, R&D investment, and professional education efforts to reduce the subsequent treatment burden for patients and the healthcare system overall. It all began in 1876, with a presentation on antiseptic surgery, delivered by British surgeon Sir Joseph Lister and attended by a medicated plaster maker by the name of Robert Wood Johnson.
Solutions like the first mass-produced sterile sutures, Carrel-Dakin system of antiseptic wound treatment, sterilization by irradiation and with the help of low-temperature gas plasma, and absorbable pads to help minimize blood loss – these legacy inventions greatly impacted clinical outcomes, survival rates, infection rates, amputations and lethal cases, as well as surgical efficiency.
Ethicon played its part by introducing several types of sutures, including MONOCRYL™ Plus Antibacterial (poliglecaprone 25) Suture to provide secure skin closure, and Coated VICRYL™ Plus Antibacterial (polyglactin 910) Suture, coated with triclosan that has been shown in vitro to inhibit bacterial colonization of the suture (S. aureus and S.epidermidis). Triclosan-coated sutures have been recommended in the World Health Organization (WHO) guidelines to reduce the risk of SSIs.
Co-creation with experts in orthopaedics stimulates regular advancements in infection control
The commitment that started in general surgery soon transitioned to other surgical fields. DePuy Synthes, the orthopaedics arm of Johnson & Johnson, lives by co-creation as its fundamental approach to product development. Striving to improve patient safety, we consistently work to leverage our collective strengths across and beyond the Johnson & Johnson enterprise. For example, the application of Janssen’s patented antibiotic coating technology to unmet needs in Trauma resulted in the introduction of a tibial nail that releases high concentrations of antibiotics into the implant’s surroundings to protect the patients from bacterial colonization on the implant surface.
At DePuy Synthes, we work closely with surgeons to address unmet needs, and together we transform insights into product innovations. Our 130+ year focus on infection prevention was bolstered sixty years ago when we partnered with the AO Foundation, whose founders established a sharp focus on infection prevention through the cutting-edge principles of open reduction and internal fixation – now accepted as global best practices in orthopaedics.
Today, initiatives like the AO Trauma Clinical Priority Program (CPP) on Bone Infection and the AO Technical Commission's Anti-Infection Global Expert Committee (AIGEC) interdisciplinary group continue to help both our organizations make significant strides in infection prevention. Through our collaborative design efforts, we share a vision of a world where surgery-related infections have become history.
Without prevention measures, infections at surgical sites can cause significant complications in trauma care, often resulting in increased mortality rates, longer hospital stays, revision surgery needs, increased use of antibiotics, extended follow-up and costly rehabilitation needs.
Infections remain a major complication in fracture care. Post-surgical infections are potential complications associated with intramedullary nailing (IMN), the most frequent surgical treatment for tibial shaft fractures (TSFs). The risk of infection in all open tibia fractures can be up to 31.2% for Gustillo IIIB and C, and the use of prophylactic antibiotics has been shown to reduce the rate of SSIs. In 2011, DePuy Synthes addressed this risk by introducing the DePuy Synthes Expert Tibial Nail with PROtect Coating that releases high concentrations of antibiotics into the implant’s surroundings. Designed to protect patients from bacterial colonization of the implant, antibiotics are released at a rate of 40% in the first hour, 70% after 24 hours and 80% after 48 hours.
The PROtect Coating consists of a thin film of poly(D,L-lactic acid) (PDLLA) containing the antibiotic gentamicin sulfate that covers the surface of the nail, including the cannulation, thereby helping to impede bacteria from adhering to the implant surface and producing biofilms. The coating releases high concentrations of antibiotics where systemically administered antibiotics find it difficult to reach. Local antibiotic beads, comprised of polymethyl methacrylate (PMMA) or bone cement,have a suboptimal release profile, are not biodegradable, and have been shown to contribute to re-infection or resistant variants. In one case series on the treatment of closed and open tibial fractures in a hospital in Munster, Germany, antibiotic-coated nails were found to be “associated with an absence of deep wound infections, good fracture healing and increasing weight-bearing capacity after 6 months.”
The DePuy Synthes Reamer Irrigator Aspirator 2 (RIA 2) System represents another significant intervention that has advanced our response to infection control. The RIA 2 system is a proprietary reaming and bone harvesting system designed for extraction of autogenous bone and debridement of infected tissues from femur and other long bones during reaming, autografting and irrigation in femur and tibia repair procedures. Irrigating fluid is passed through the cannula of the drive shaft and reamer heads, then aspiration fluid is drawn through the tube assembly and out through the aspiration tube. As of today, a full 15 years after introduction of the first RIA system, no direct alternative to our patented technology with active removal of intramedullary infection in the canal exists on the market. Our advanced irrigation system allows for effective washout for IM nail exchange procedures, providing an efficient method for removal of infected bone tissue. As a testament to its success, one study reported a 0% rate of infection at the 6-month follow-up point (N=11).
What does the next wave of infection control hold for the field of orthopaedics?
At the 2019 eCM XIX Orthopaedic Infection Congress, a key research event run by the AO Research Institute, organizers named fracture-related infection (FRI), periprosthetic joint infection (PJI) and osteomyelitis as three of the most challenging complications seen today in orthopedic and musculoskeletal trauma surgery. Since delays in healing, degradations to functional outcomes, and high socio-economic costs often result from such infections, DePuy Synthes and experts around the globe focus on addressing these risks through the development of effective preventative solutions. To learn more about J&J solutions, please visit www.jnjmedicaldevices.com.
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Metsemakers et al. The use of gentamicin-coated nails in complex open tibia fracture and revision cases: A retrospective analysis of a single center case series and review of the literature. Injury 2015.
Fuchs T, Stange R, Schmidmaier G, Raschke MJ. The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study. Arch Orthop Trauma Surg. 2011 Oct;131(10):1419-25. doi: 10.1007/s00402-011-1321-6. Epub 2011 May 24. PMID: 21617934; PMCID: PMC3175046.
Zalavras CG, Singh A, Patzakis MJ. Novel technique for medullary canal debridement in tibia and femur osteomyelitis. Clin Orthop Relat Res. 2007;461:31–34.
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