Allure Best of Beauty 2024: Breakthrough Winners

Allure Best of Beauty 2024: Breakthrough Winners

https://www.allure.com/story/best-of-beauty-breakthrough-awards-winners-2024#Sylke-Adhesive-Wound-Closure

Best Breakthroughs:

Sylke Adhesive Wound Closure

Post-op wound care that wears comfortably and securely without irritating skin—but when you're ready to take it off, it peels off as easily as a Post-it. And that can mean plastic surgery procedures with less-noticeable scars.

When you're scheduled for surgery, be it a cosmetic procedure or a medical one, usually the last thing on your mind is what your surgeon will use to keep your incision closed. But the humble bandage, or "surgical wound dressing" in doctor-speak, is more pivotal in your aftercare than you might have previously (or ever) thought. "The reason an incision usually does not heal well [resulting in a raised, red, or obvious scar] is that there is too much tension on it," says Melissa Doft, MD, a double board-certified plastic surgeon in New York City. "What a plastic surgeon will do is close the body in multiple layers. The wound dressing on top is that last protection so the wound has time to close and to also take off the pressure from the surface."

Yet, while surgical techniques have progressed to dizzying new technological heights, once you’re stitched up, the options for wound dressing are far less advanced. "How is it in the 21st century that we have robotic surgery, gene therapy, lasers—and it's like the technology innovation curve ends the moment that the surgery ends?" says Mark Mofid, MD, a board-certified facial plastic surgeon in San Diego and a clinical assistant professor of plastic surgery at the Johns Hopkins University School of Medicine. "We go back to this Civil War-era technology of applying surgical dressings." He notes that gauze has been around for at least 150 years, and the next breakthrough innovation in surgical dressings to hit the market was 3M's paper adhesive tape Steri-Strips in 1962. They continue to be one of the standard choices for surgeons along with a surgical superglue called Dermabond, which was released in 1998.

Fueled by his dissatisfaction with existing options, Dr. Mofid, who has been practicing for almost 30 years, saw an opportunity to make a surgical dressing that would: a) provide a better user experience for patients, b) help create a better surgical scar outcome, and c) reduce instances of skin reactions linked to surgical dressings. During the 2020 lockdown when elective surgeries were put on hold for about a month and a half, Dr. Mofid finally put his idea in motion, creating the prototype for what would become the Sylke Adhesive Wound Closure. It is a flexible dressing made of silk fibroin (more on that soon) with a gentle adhesive—and when you combine those three things, you get a surgical dressing that "is comfortable and doesn't cause redness or irritation," says Steven Teitelbaum, MD, a board-certified plastic surgeon in Los Angeles, who uses Sylke in his practice. "Surgical scars look finer; skin looks smoother where you’ve sewn it together."

Medical-grade silk (also in implants, surgical mesh, and more) has been used safely in surgery for decades: "Silk is made up of two proteins—sericin and fibroin," explains Daniel Rouhani, a clinical researcher at Johns Hopkins University School of Medicine and the director of clinical trials and research and development for Sylke. "Natural silk that you see used in textiles contains the sericin protein, which gives it that sheen and natural glossiness. But some patients can have allergies to it and it also can have bacteria grow on it." Medical-grade silk fibroin, however, is washed and has had 99.99% of the sericin removed, explains Rouhani, so it simply contains the fibroin protein. "Because it is medical-grade fibroin, it doesn't cause any kind of reaction in the body," he explains.

Dr. Mofid used samples of a bioengineered silk surgical mesh to create the prototypes for Sylke, perfecting his design: a 32 cm. long by 2.5 cm. wide soft strip with a strong, yet easy-to-remove adhesive that moves with the skin, but won’t damage it upon removal.

Dr. Mofid was looking to skirt the pitfalls that come with the three prevalent wound dressings on the market—tape and gauze, Steri-Strips, and Dermabond Prineo—which can impede the healing process, he explains. Gauze dressings don't hold up in water and will get soggy if you shower post-surgery. Steri-Strips, while waterproof, aren't flexible, meaning they either fall off too early or pull on the wound and cause blistering that sometimes can be the most painful part of the post-op experience. "It's an inelastic, paper-lined tape and everyone knows that after surgery you swell," says Dr. Mofid. "If I asked you to crumple yourself into a ball and covered you in newspaper, then [asked you to] stand up, you're going to tear through it." Dermabond Prineo, the surgical superglue that holds skin together using liquid adhesive and a polyester mesh, was supposed to fix this problem. But when the liquid adhesive is applied to the polyester mesh, it "cures" (hardens) and a very low dose of formaldehyde is potentially produced as a byproduct allergen of the bonding process. In 2024 alone, there have been over 150 reports in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database from doctors reporting injuries including skin irritation in patients who have received Dermabond Prineo post-surgery. "When the Dermabond glue is put on wounds you see more redness and more irritation," says Dr.Teitelbaum. "That's because the Dermabond [can] trap bacteria and fluid under the skin surface and doesn’t let it drip out at all, and just a little bit of drip out of the wound is important."

Allure reached out to Dermabond for comment and a representative for the brand responded that it is "important to note that Dermabond Prineo is not an over-the-counter product and can only be used by health-care professionals in surgical settings. Our Dermabond Prineo skin closure system helps reduce operating time, improves cosmetic outcomes, reduces the risk of separation, and has lower infection rates compared to the standard subcuticular-suture method of skin closure."

Sylke, with its meshed silk fibroin and gentle-yet-long-lasting adhesive (Dr. Mofid likens it to the glue on the back of a 3M Post-it), solves these all too common issues by providing patients with a flexible, water-resistant wound closure that wears for 14 days. Since it became available about a year ago, there are zero reports on MAUDE of skin irritations or allergic reactions. And because silk itself is naturally hydrophobic, meaning it repels water, there's no risk of soggy bandages or bacterial infections caused by waterborne organisms.

Clinical testing of Sylke was done with internal controls, explains Rouhani, where patients received both Sylke and a traditional dressing on their surgical incisions. "This is a very rare type of study," says Rouhani. "A lot of studies take 200 patients that have already had the previous dressing and then you take 200 patients that receive the new dressing and you compare the two." However, that type of study would have too many variables to take into account, like whether a patient is predisposed to allergies to a material, the area where the surgery was performed, their level of activity, how their body heals, the surgeon. In order to have the most accurate comparison, Dr. Mofid needed the only variable to be the type of dressing used on the wound.

The first study was conducted on 25 tummy tuck and breast reduction patients with each receiving Dermabond Prineo on one side and the Sylke dressing on the other. Fifty-two percent of patients had a visible rash on the Dermabond Prineo side of the incision while none had a similar reaction on the side that was dressed with Sylke. A follow-up study was done on 50 tummy tuck, arm lift, and breast reduction patients with the same protocols, but this time testing Sylke against Steri-Strips. Twenty percent had a reaction on the Steri-Strips side, while no patients had irritation or redness on the Sylke side. Additionally, the team tested both dressings for longevity, with Steri-Strips detaching partially or completely on 75% of patients while the Sylke dressing partially detached on 18% before the two-week mark.

In addition to improvement in the immediate post-surgery period, the clinical testing also showed that patients had better healing and scar results of the incisions that were dressed with Sylke versus Dermabond Prineo or Steri-Strips. "Even though it wasn't a clinical end point, we found much better scars in our patients, as well, meaning [scars] are thinner, flatter, less red, less symptomatic (they don't itch and are not tender), and they heal uneventfully with no separation, infections, or allergic contact dermatitis," explains Dr. Mofid. "If you cause an inflammatory hypersensitivity reaction, you’ll wind up with worse scars." But Sylke keeps the skin calm and does not traumatize the top layer of skin with a too-strong adhesive, the so-called "ripping off the Band-Aid" effect.

Dr. Doft, who primarily uses Steri-Strips in her practice, noted that after playing with Sylke (she hasn’t used the product on a patient), it felt "stickier" than Steri-Strips and had more stretch and flexibility. “I think that’s definitely an advantage because as you're moving your body, you’re not pulling against this tape. It moves with the skin very nicely,” says Dr. Doft, noting she might consider switching to Sylke for a procedure like an abdominoplasty (a tummy tuck), when the comfort factor would be appreciated by patients wearing bandages for two weeks.

Dr. Teitelbaum, who was an early adopter of Sylke when it launched last October, now uses it exclusively for every tummy tuck, breast lift, and breast reduction he performs. "I've been using [Sylke] at my practice and I have not had a single patient with irritation," says Dr. Teitelbaum. "It's very comfortable, it's very flexible, it moves in three dimensions, it goes on easily and comes off easily. There are a lot of things where there are pros and cons, but I have not yet seen a con, other than the cost."

Sylke is available for professionals (it can also be purchased over the counter through Sylke’s site), and it carries a hefty price tag—a single bandage costs $120 and the minimum order on the website is a box of 10 that rings in at $1,200. Dr. Teitelbaum noted that he still uses Steri-Strips on small incisions because Sylke is sold only in large packets, making it cost-prohibitive for smaller wounds. "You open it once, you’re only going to use it on one patient," he says. "Financially you just wouldn’t use it for a one-and-a-half-inch incision." Dr. Mofid notes that one of the biggest hurdles he and his team has faced has been getting Sylke into larger hospital networks that already have bulk-order deals with other manufacturers. Health-care purchasers aren't exactly known for their willingness to spend more money in the pursuit of marginally better outcomes for patients. But doctors in private practice, especially plastic surgeons in pursuit of the best cosmetic outcome, are some of Sylke's biggest champions thus far. "To me, the scar in a breast lift, breast reduction, or tummy tuck is the most important thing, and anything I can do to improve the early healing and likely improve the final outcome is worth it," says Dr. Teitelbaum. "I think most surgeons would agree with that. If there are people who are not using this, they are either unaware of the data or there’s a financial impediment."

Currently, Sylke is available in a single, long, skinny strip, but Dr. Mofid dreams of creating more iterations for surgeries with higher infection rates, like orthopedics as well as at-home versions for everyday use. "Orthopedic surgeons want to use it for arthroplasties [joint replacement surgery]," he says. "But they need a slightly wider dressing and a stickier adhesive because the knee has thicker skin than the breast. And I'd love to create a Band-Aid-like product. If you've ever had a cut on your hand and you put a Band-Aid on, good luck taking a shower and having it not get soggy. This [would be] perfect for it. I'd like to create something for abrasions. I'd like to create something for skin-graft donor sites and burn centers." Dr. Mofid notes that each of those new SKUs would need to go through the FDA regulatory process all over again (wound dressings like Sylke must pass tests to show they adhere to FDA guidelines). So for now his focus is on spreading the word to surgeons and patients about Sylke's potential.

Written by Megan McIntyre

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