Groundbreaking New Silk Surgical Dressing, SYLKE™, Launches To Prevent Skin Injuries And Infections, Improving Scarring Outcomes

Head-to-head data published in the Aesthetic Surgery Journal Open Forum shows SYLKE™ wound closure prototype outperforms current standard of care

La Jolla, CA /PRNewswire/ - Today, Sylke Inc launched SYLKE™, the first dressing made of pure hypoallergenic silk fibroin.† SYLKE™ is designed to enhance healing across surgical wounds and to reduce complications and infections which can lead to poor scarring outcomes.^1,2 Based on head-to-head data^* published today in the Aesthetic Surgery Journal (ASJ) Open Forum (https://academic.oup.com/asjopenforum/article/doi/10.1093/asjof/ojad071/7238111), SYLKE™ adhesive wound closure prototype outperformed DERMABOND™️ PRINEO™️ (p<0.001) across all measures, significantly reducing the incidence of medical adhesive-related skin injuries (MARSIs). The study was published in collaboration with The Johns Hopkins University School of Medicine and the University of California San Diego.

Each year, 1.5 million Americans suffer from MARSIs caused by synthetic surgical adhesive dressings, leading to painful complications, including surgical site infections (SSIs) and poor scarring outcomes.^3,4 The related cost to the US healthcare system is $3.3 billion each year.5 The current standard of care, including inflexible tapes, synthetic materials, and aggressive liquid glue medical adhesives often lead to skin tears, blisters, cell damage and allergic contact dermatitis (ACD).^4,6 These problems are often overlooked, vastly underreported and preventable.

"SYLKE™️ aims to revolutionize surgical wound care by eliminating medical adhesive-related skin injuries that lead to complications such as infections and poor scarring outcomes. We see a benefit to millions of patients and aim to decrease the financial burden on the healthcare system by bringing SYLKE™ to market," said M. Mark Mofid, MD, FACS, an assistant Professor of Plastic Surgery at The Johns Hopkins University School of Medicine and inventor of SYLKE™. "Scarring from surgical procedures dramatically affects aesthetics and impacts patients' mental health and overall well-being. We are especially pleased to extend the art of scar-minimizing wound closure to all healthcare professionals, patients, consumers and military personnel."

In a head-to-head clinical trial*, the SYLKE™ prototype significantly outperformed DERMABOND™️ PRINEO™️ (p<0.001) across all measures, including: skin discomfort (4% vs. 64%), ACD including rash, itching and erythema (irritated, red skin) (0% vs. 52%), need for topical steroids or antibiotics for ACD and SSIs (0% vs. 52%), and dressing removal time (47 seconds vs. 1 minute and 39 seconds). SYLKE™ and DERMABOND™️ PRINEO™️ were evaluated in abdominoplasty (tummy tuck), body lift, breast reduction and mastopexy (breast lift) procedures.

A head-to-head comparison (n=50) of the SYLKE™ prototype versus the 3M™️ Steri-Strip™️ Skin Closure device will be published in spring 2024 adding to the growing body of evidence supporting the safety and efficacy of SYLKE™. Multispecialty studies using SYLKE™ are in the planning stages at Johns Hopkins this fall.

SYLKE™ is commercially available and can be purchased over-the-counter by healthcare professionals and the general public through www.sylke.com. Five-unit introduction boxes will be launched at the cost of $115/strip — up to 32 percent less than a current standard of care — with volume discounts for large-scale buyers, such as hospital systems and clinics.

Data from the SYLKE™ head-to-head clinical trial with DERMABOND™️ PRINEO™️ will be presented at:

American College of Surgeons (ACS) Clinical Congress 2023
Boston, Massachusetts
Tuesday, October 24 12:45 PM - 2:15 PM ET
Session: SF215 | Plastic and Maxillofacial Surgery II
Abstract 4960: Superiority Of Silk Wound Dressing Over The Dermabond® Prineo® Skin Closure System: A Prospective Randomized, Single-blinded Clinical Trial [oral]
Location: BCEC, 151AB, Level 1

American Society of Plastic Surgeons (ASPS) 2023 Annual Meeting (Plastic Surgery The Meeting)
Austin, Texas
Saturday, October 28 2:10 PM ET
Session: Research & Technology 6 [oral]
Abstract 37829: Superiority of Silk Wound Dressing Over the Dermabond® Prineo® Skin Closure System: A Prospective, Randomized, Single-Blinded Clinical Trial [oral]
Location: ACC, Meeting Room 9C, Level 3

^*25 patients participated in the clinical trial; each patient's wound was dressed half in DERMABOND PRINEO and half in the SYLKE prototype, so each patient served as their own internal control.¹

^†Silkworm silk, commonly used in healthcare and textiles, is made up of two proteins – fibroin and sericin. Fibroin is the internal fiber that gives silk its threadlike structure and sericin is the glue that encases the fibroin. By removing the sericin protein, SYLKE's fibers are nearly pure fibroin—a naturally hypoallergenic and strong material.²

About SYLKE™️
SYLKE™️ Adhesive Wound Closure is the first premium, naturally sourced, and water-resistant "all-in-one" system designed with hypoallergenic materials to enhance wound healing and reduce surgical site complications to improve patient outcomes.

Made of pure silk fibroin, the SYLKE™ patented breathable mesh design gently adheres seamlessly to irregular wound surfaces remaining water-resistant for up to two weeks without the need for reapplication. The inherent elasticity of the mesh design allows for SYLKE™ to minimize shear forces on the skin as a result of swelling or motion while maintaining precise wound edge approximation during the healing process. SYLKE™ is available as a 2.5 cm wide strip with an easily peeled paper backing that can be effortlessly cut and applied within seconds to post-surgical incisions, cuts, or simple lacerations thus eliminating the need for additional applicators, glues, dressings or devices.

SYLKE™ was registered as an FDA Class 1 medical device in October 2023.

For additional information, please visit www.sylke.com.

About Sylke, Inc.
Sylke, Inc based in La Jolla, CA is led by M. Mark Mofid, MD, FACS, an assistant Professor of Plastic Surgery at The Johns Hopkins University School of Medicine alongside leading scientists and healthcare professionals. Unsatisfied with options for surgical site dressings, Mofid invented the first naturally sourced and hypoallergenic dressing for the market – SYLKE™.

For additional information, please visit www.sylke.com.

References

^1. Rouhani, DS, Singh, NK, Chao, JJ, et al. Silk Bioprotein as a Novel Surgical-Site Wound Dressing: A Prospective, Randomized, Single-Blinded, Superiority Clinical Trial. 2023 Oct. Aesthetic Surgery Journal [cited 2023 Oct 19]. Available from: https://doi.org/10.1093/asjof/ojad071

^2. SYLKE data on file, 2023.

^3. Swanson, S. Prototype Development of a Temperature-Sensitive High-Adhesion Medical Tape to Reduce Medical-Adhesive-Related Skin Injury and Improve Quality of Care. Int J Mol Sci [Internet]. 2022 Jul [cited 2023 Sept 21]; 23(13): 7164. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266747/

^4. Fumarola S, Allaway R, Callaghan R, et al. Overlooked and underestimated: medical adhesive-related skin injuries. J Wound Care [Internet]. 2020 Mar [cited 2023 Sept 7]; 29(Sup3c):S1-S24. Available from: https://www.magonlinelibrary.com/doi/epub/10.12968/jowc.2020.29.Sup3c.S1

^5. Centers for Disease Control and Prevention. Surgical Site Infection Event (SSI): National Healthcare Safety Network; 2023. 41 p. Report No.: 9.

^6. Hitchcock, J, Haigh, DA, Martin N, et al. Preventing medical adhesive-related skin injury (MARSI). British Journal of Medicine [Internet]. 2021 Aug [cited 2023 Sept 6]; 30(15): 2052-2819. Available from: https://www.britishjournalofnursing.com/content/product-focus/preventing-medical-adhesive-related-skin-injury-marsi/#:~:text=A%20MARSI%20resulting%20from%20any,infected%20in%20at%2Drisk%20patients.