Important Considerations for Wound Dressing Development and Testing Using AATCC Test Method 100

Solid phase dressings are a standard for companies developing antimicrobial dressings for the wound care market. Dressings are available in many form factors, including woven and non-woven textiles, polymer foams (e.g., polyurethane), and swelling and/or absorbent fibers, to name a few. The American Association of Textile Chemists and Colorists (AATCC) professional association lists Test Method 100 as a suitable technique for assessing the effects of antimicrobial finishes on textile materials.

This method is recognized by the U.S. Food and Drug Administration (FDA) as a standard technique for establishing the antimicrobial activity of wound dressings for 510(k) filings, and is also used throughout Europe and Asia for testing the efficacy of antimicrobial wound dressings. Despite its widespread use, AATCC Test Method 100 is not free of challenges, and is often modified to fit a given material, use scenario, or application, as evidenced by the numerous modification standards published by ASTM International (e.g., ASTM E2149, E2180, E2722, E2756). In this work, iFyber will present a number of case studies that highlight the challenges associated with AATCC Test Method 100, and summarize some key variables that are important when screening new technologies using this test method. iFyber presents data on how testing medium, test volume, dressing saturation, test timepoints, sample size, and antimicrobial neutralization can affect the outcomes of a given study.

High variability of test results is also a hallmark of AATCC Test Method 100, so iFyber also presents statistical methods that can be used in method development to make informed decisions on modifying the test with the goal of providing statistically defensible conclusions regarding best performing candidates. This approach has been successfully used to down-select prototypes during early dressing development.