Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) <51>

根据美国药典 (USP) <51> 对可吸收静电纺丝纤维基质进行抗菌效果测试

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Abstract

Contamination of surgical, traumatic, and chronic wounds with microorganisms presents a challenge to successful wound healing. In the present in vitro study, a synthetic electrospun fiber matrix (SEFM) cleared for use in the management of chronic, surgical, and traumatic wounds underwent USP (United States Pharmacopeia) <51> Antimicrobial Effectiveness Testing to determine its in vitro effectiveness against various microorganisms commonly found in non-healing wounds. The SEFM was tested in both sheet (s-SEFM) and micronized form (m-SEFM) against Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Aspergillus brasiliensis, Candida albicans, Proteus mirabilis, and Enterococcus faecalis. Testing was performed per the USP <51> standard on days 7, 14, and 28. Both the s-SEFM and m-SEFM met the USP <51> acceptance criteria for all microorganisms. The results obtained for s-SEFM demonstrated >1-log(10) reduction against E. coli, S. aureus, P. aeruginosa, P. mirabilis, E. faecalis, and C. albicans at day 7; >3-log(10) reduction with no detection of these microbes at days 14 and 28, and no increase from initial inoculum at days 7, 14, and 28 against A. brasiliensis. The results obtained for m-SEFM demonstrated >3-log(10 )reduction with no detectable microorganisms at day 7. The results observed in this study indicate that the SEFM is effective in vitro at inhibiting bacterial and fungal growth and colonization per USP <51> testing.

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