A primary goal of treating any wound? Avoiding complications that may lead to infection. Whether it’s a child who scraped their knee playing outside or a patient who just had surgery, infections can slow healing or delay subsequent treatment. In some cases, they cause medical complications resulting in hospital readmittance. When it comes to the latter, the most common type of hospital-acquired infection is a surgical site infection (SSI), representing up to 20% of infections patients get at a hospital. And they’re no small thing: SSIs are associated with prolonged hospital stays and increased risk of admission to intensive care, morbidity and mortality, and add significant additional costs to the U.S. healthcare system.
"SSIs are caused by a battle between your immune system and an exogenous cell, usually bacteria,” says Dr. Liza Ovington, Consulting Medical Director, Wound Closure & Healing at Johnson & Johnson MedTech. “An infection of any kind is the result of your immune system losing that battle, and it manifests clinically, physically and macroscopically with redness, pain, heat and swelling.”
There are three types of SSIs: superficial incisional, which occur in the outermost layers of the incision on the skin; deep incisional, which occur in deeper tissue layers such as muscle, fascia or peritoneum; and organ/space, which involve organs or other internal body spaces and may present as an abscess.
Hospitals take many precautions to create sterile environments to reduce all of these types of infections, but it’s impossible to completely eliminate bacteria, according to Dr. Ovington.
“Surgical wounds are created in an environment that is as sterile as we can make it,” Dr. Ovington says. “We sterilize the table that the patient is on. We use sterile barrier precautions: gloves, gowns, caps and masks. We use sterile instruments. Unfortunately, the only things in the operating room that we can't sterilize are the people.”
Indeed, by and large the biggest source of bacteria is the patient themself. “The average person contains more than 4 pounds of bacteria—most of it in your gut as part of a healthy microbiome—and there are more bacteria cells in and on your body than there are human cells,” Dr. Ovington says. Bacteria are an essential part of human life, “but the problem is when they leave the places that they normally live and enter a sterile part of the body during surgery.”
There’s incredible potential when it comes to data generation, and the ability to capture data throughout the patient’s entire perioperative experience could generate more insights for care teams to understand or even possibly predict SSOs in the future.
Estimates show rates of post-operative complications occur in up to 20% of patients, and 26.5% of surgical readmissions are because of wound complications. The most common complication of an infection is that it slows down healing, but in worst-case scenarios, an infection could spread, causing a patient to become septic and potentially die, Dr. Ovington says.
That’s why it’s so critical to advance the study of—and solutions for—SSIs. And as Dr. Niels-Derrek Schmitz, Global Medical Affairs Lead of Wound Closure & Healing at Johnson & Johnson MedTech puts it, the potential for solutions is vast: “Everything from robotic-assisted surgery to wearable devices to AI-driven systems are poised to help improve patient outcomes.”
The role of sutures in SSI risk—and prevention
There are currently no comprehensive global standards to assess, classify and track unified measures of SSIs, resulting in a wide array of care standards and variability in readmission rates and healing timelines. But, Johnson & Johnson MedTech is part of a global effort working to develop a standardized approach to classifying surgical site outcomes (SSO) for surgeons and wound care teams to more fully capture the scope and incidence of postoperative complications, enabling improved approaches to prevention. The concept of this SSO classification is similar to the TNM Staging System, a globally recognized standard for classifying malignant tumors.
Some countries and surgical societies have also begun creating their own standards. The guidelines address multiple risk factors for SSIs, including a small, yet still significant risk factor for infections: sutures.
“When you create a surgical incision, you release small amounts of bacteria from the lower layers of the skin into the surgical wound. And if you've got a good immune system, your body can deal with those small numbers,” Dr. Ovington says. However, to close those incisions, surgeons must use sutures, upon which bacteria can attach, colonize, and form a biofilm that enables them to hide from a person’s immune system cells and even most antibiotics.
As part of a suture expert team at Johnson & Johnson MedTech, Dr. Ovington worked to address this issue. “We decided to coat our suture in something that makes it less hospitable for bacteria to attach to and colonize,” she says. The Ethicon Plus Antibacterial Sutures are coated in triclosan, an antiseptic that has been used in hospital products for more than 50 years.
“We could have coated with antibiotics, but in the interest of antimicrobial stewardship, we refrained, because that would be a prophylactic overuse of antibiotics that might contribute to antimicrobial resistance,” Dr. Ovington says. “Triclosan, however, happens to be an antiseptic that is not harmful to human cells, but harmful to bacterial cells.”
The Ethicon Plus Antibacterial Sutures are the only triclosan-coated sutures available worldwide, with meta-analyses showing SSI risk reduction of up to one-third against the most common pathogens. And STRATAFIX™ Plus Knotless Tissue Control Devices* are the only commercially available barbed suture coated with triclosan. This effectiveness is recognized as a standard around the world. The World Health Organization, Centers for Disease Control and Prevention, and 12 other countries/surgical societies have all formed guidelines for SSI prevention that include recommendations for the use of antibacterial sutures based on the Plus Sutures clinical evidence.
“After 20 years of data and more than 45 randomized controlled trials, the triclosan-coated sutures have demonstrated less risk of SSI than the non-triclosan sutures,” Dr. Ovington says. Before all these studies, it had been assumed that sutures always introduced a risk factor, but because they’re a necessary part of wound closure in surgery, the industry overlooked that aspect of infection prevention.
Not only does this make surgery safer for the patient, it also reduces hospital costs associated with treating SSIs. In the United States, treating complications from a single surgical infection can cost up to $33,329. And overall, poor surgical site outcomes may result in up to $10 billion in direct and indirect medical costs each year.
The additional cost for Plus Sutures versus the same suture without the antibacterial coating is very minor per patient when compared to other SSI prevention measures such as wound protectors. “But by preventing SSIs, a hospital can save a lot of money and provide better outcomes for the patient,” Dr. Ovington says. Economic analyses estimate that payers would avoid more than $1,000 in superficial and deep-incisional SSI-related costs per patient over 12 months if triclosan-coated sutures were used in colorectal surgery versus traditional closures.
“Many risk factors, such as a patient’s existing health history, can’t be changed,” Dr. Ovington says, “but we can make sure that the suture is not introducing an incremental risk as part of an overall approach to infection prevention.”
Digital and data solutions for infection prevention
In addition to sterilizing the surgical environment and minimizing bacteria present, including harnessing laminar air flow (which pushes air out of the operating room to reduce the presence of airborne contaminants), a major focus of infection prevention revolves around minimally invasive surgery options. Robotic surgical systems can enhance precision and minimize tissue trauma during operations, leading to lower infection rates.
Simply put: “The bigger your incision, the more likely you are to have an infection, because there's more tissue damage and a bigger opening for bacteria to get into,” Dr. Ovington says. “If you compare an 8-inch incision made in traditional surgery to a 1-inch incision made through laparoscopy or robotics, there's usually less infection associated with these smaller wounds.”
That’s where Johnson & Johnson MedTech’s surgical expertise comes in.
“New digital solutions are also aimed at improving infection control practices, enhancing patient engagement and ensuring optimal surgical protocols,” says Dr. Schmitz.
For example, the Polyphonic™ digital ecosystem is a software solution that will connect data across world-class surgical technologies, robotics, and surgical software and allow for patient monitoring based on new, standard reporting guidelines as determined in SSO classification.
The future of preventing SSIs
Johnson & Johnson MedTech is continuously working on advancing surgery techniques, specifically moving toward less invasive surgery options, Dr. Ovington says. “Other advancement opportunities for the future include data surveillance, through AI-driven systems—like mobile apps—to remind and educate patients about postoperative care instructions,” Dr. Schmitz says. Another possibility for the future of SSI prevention is wearable devices that can monitor patients' vital signs and recovery progress in real-time, which could alert medical staff to any concerning changes that may indicate complications—and allow for more timely intervention that would improve patient outcomes, he explains.
The bottom line: There’s incredible potential when it comes to data generation, and the ability to capture data throughout the patient’s entire perioperative experience could generate more insights for care teams to understand or even possibly predict SSOs in the future.
The biggest advancements, in Dr. Ovington's mind, will be around personalized medicine. “So many factors that impact infection prevention are personalized, such as nutrition and hydration, and many people don’t understand how important they are,” Dr. Ovington says. Personalized options that can give the patient information in a way they will better understand their own particular risks and how to mitigate them would have enormous benefits in the effort to reduce SSI and impact surgical site outcomes.
*For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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