LANGHORNE, Pa., Oct. 6, 2021 /PRNewswire/ -- NEXGEL, Inc. ("NEXGEL" or the "Company"), a leading provider of ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications, today announced positive results from its validation study, demonstrating the antimicrobial properties of its SilverSeal® product line. The silver-impregnated hydrogel-based product was found to be up to 99 percent effective in reducing common bacteria, fungus and yeasts that can be present after a superficial skin injury.
"NEXGEL's SilverSeal® is now proven to address one of the many pain points faced by those with skin abrasions — the fear of infection from skin injuries," said Adam Levy, NEXGEL CEO. "The positive results of this study allow NEXGEL to claim its wound care products have the ability to prevent common infections such as MRSA and Strep, which lead to more serious infection. These antimicrobial properties are important for specific consumer segments such as athletes who often are exposed to infection due to frequent skin tears. NEXGEL is committed to bringing our products to market to improve the standard of care and provide consumers and physicians with effective tools to prevent bacterial infections that will delay or worsen healing for patients in need."
The study design was as follows:
- NEXGEL's SilverSeal® product line underwent Test Method 100, which the American Association of Textile Chemists and Colorists (AATCC) lists as the industry standard for evaluating the antimicrobial efficacy of dressings.
- The AATCC Test Method 100 is also recognized by the U.S. Food and Drug Administration (FDA) as a standard technique for establishing antimicrobial activity within wound dressings for 510(k) filings.
- The Test Method 100 is designed to quantitatively test the ability of fabrics and textiles to inhibit the growth of microorganisms or kill them, over a 24-hour period of contact.
- During this test, control and test fabric swatches were inoculated with microorganisms. Bacteria levels on both control and test fabrics were determined at "time zero" by elution in a large volume of neutralizing broth, followed by dilution and plating.
- A control was performed to verify that the neutralization method effectively neutralizes the antimicrobial agent in the fabric. Additional inoculated control and test fabrics were incubated in sealed jars.
- The results were taken after the 24-hour period, and the reduction of microorganisms relative to initial concentrations and the control fabric was calculated.
Key results from a comparison of SilverSeal® to a standard-of-care gauze pad over a 24-hour interval showed:
- SilverSeal® was ~99% effective in reducing streptococcus pneumoniae, compared to ~13% efficacy of the reference gauze.
- SilverSeal® was ~99% effective in reducing staphylococcus epidermidis, compared to ~17% efficacy of the reference gauze.
- SilverSeal® was ~99% effective in reducing faecalis bacterial infection, compared to ~11% efficacy of the reference gauze.
- SilverSeal® was ~99% effective in reducing E. coli infection, compared to 31% efficacy of the reference gauze.
"These antimicrobial properties, in particular the reduction of pathogens such as methicillin resistant staph aureus and streptococcal variants, as well as the hydrating and soothing nature of hydrogel, are the very reason that our team uses this product as part of our treatment for superficial injuries to the skin," says Dr. Stephen Brigido, Director of the Reconstructive Foot and Ankle Fellowship at Lehigh Valley Hospital. "Both athletes and the general public have benefited from SilverSeal® when suffering from superficial abrasion to the skin, such as turf burn and road rash."
About NEXGEL, INC.
NEXGEL is a leading provider of ultra-gentle, high-water-content hydrogels for healthcare and consumer applications. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. Alongside its strategic partners, NEXGEL has formulated more than 200 different combinations to bring natural ingredients to gentle skin patches that can be worn for long periods of time with little to no irritation.
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