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

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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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          Human skin wounds: a major and snowballing threat to public health and the economy.

          Chandan Sen, Gayle M Gordillo, Sashwati Roy … (2009)
          ABSTRACT In the United States, chronic wounds affect 6.5 million patients. An estimated excess of US$25 billion is spent annually on treatment of chronic wounds and the burden is rapidly growing due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity worldwide. The annual wound care products market is projected to reach $15.3 billion by 2010. Chronic wounds are rarely seen in individuals who are otherwise healthy. In fact, chronic wound patients frequently suffer from "highly branded" diseases such as diabetes and obesity. This seems to have overshadowed the significance of wounds per se as a major health problem. For example, NIH's Research Portfolio Online Reporting Tool (RePORT; http://report.nih.gov/), directed at providing access to estimates of funding for various disease conditions does list several rare diseases but does not list wounds. Forty million inpatient surgical procedures were performed in the United States in 2000, followed closely by 31.5 million outpatient surgeries. The need for post-surgical wound care is sharply on the rise. Emergency wound care in an acute setting has major significance not only in a war setting but also in homeland preparedness against natural disasters as well as against terrorism attacks. An additional burden of wound healing is the problem of skin scarring, a $12 billion annual market. The immense economic and social impact of wounds in our society calls for allocation of a higher level of attention and resources to understand biological mechanisms underlying cutaneous wound complications.
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            Candida albicans Biofilms and Human Disease.

            Clarissa J. Nobile, Alexander D. Johnson (2015)
            In humans, microbial cells (including bacteria, archaea, and fungi) greatly outnumber host cells. Candida albicans is the most prevalent fungal species of the human microbiota; this species asymptomatically colonizes many areas of the body, particularly the gastrointestinal and genitourinary tracts of healthy individuals. Alterations in host immunity, stress, resident microbiota, and other factors can lead to C. albicans overgrowth, causing a wide range of infections, from superficial mucosal to hematogenously disseminated candidiasis. To date, most studies of C. albicans have been carried out in suspension cultures; however, the medical impact of C. albicans (like that of many other microorganisms) depends on its ability to thrive as a biofilm, a closely packed community of cells. Biofilms are notorious for forming on implanted medical devices, including catheters, pacemakers, dentures, and prosthetic joints, which provide a surface and sanctuary for biofilm growth. C. albicans biofilms are intrinsically resistant to conventional antifungal therapeutics, the host immune system, and other environmental perturbations, making biofilm-based infections a significant clinical challenge. Here, we review our current knowledge of biofilms formed by C. albicans and closely related fungal species.
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              Multiple bacterial species reside in chronic wounds: a longitudinal study.

              K. Krogfelt, Bo Jørgensen, Kristine Gjødsbøl … (2006)
              The aim of the study was to investigate the bacterial profile of chronic venous leg ulcers and the importance of the profile to ulcer development. Patients with persisting venous leg ulcers were included and followed for 8 weeks. Every second week, ulcer samples were collected and the bacterial species present were identified. More than one bacterial species were detected in all the ulcers. The most common bacteria found were Staphylococcus aureus (found in 93.5% of the ulcers), Enterococcus faecalis (71.7%), Pseudomonas aeruginosa (52.2%), coagulase-negative staphylococci (45.7%), Proteus species (41.3%) and anaerobic bacteria (39.1%). Resident bacterial species were present in all the ulcers. In 76% of the ulcers, two or more (up to five) resident bacterial species were found. The most common resident bacterial species were S. aureus and P. aeruginosa. Furthermore, ulcers with P. aeruginosa were found to be significantly larger than ulcers without the presence of P. aeruginosa (P < 0.005). Our study demonstrated that the chronic wound is colonised by multiple bacterial species and that once they are established many of them persist in the wound. Our results suggest that the presence of P. aeruginosa in venous leg ulcers can induce ulcer enlargement and/or cause delayed healing.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Cureus
                Journal ID (iso-abbrev): Cureus
                Journal ID (issn): 2168-8184
                Title: Cureus
                Publisher: Cureus (Palo Alto (CA) )
                ISSN (Electronic): 2168-8184
                Publication date (Electronic, pub): 6 December 2023
                Publication date (Electronic, collection): December 2023
                Volume: 15
                Issue: 12
                Electronic Location Identifier: e50055
                Affiliations
                [1 ] Clinical Research, Acera Surgical, Inc., St. Louis, USA
                [2 ] Research and Development, Acera Surgical, Inc., St. Louis, USA
                Author notes
                Article
                DOI: 10.7759/cureus.50055
                PMC ID: 10768939
                SO-VID: 7e5f2cfe-34ce-4847-a759-18d299bd101a
                Copyright © Copyright © 2023, Sallade et al.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date accepted : 26 November 2023
                Categories
                Subject: Other
                Subject: General Surgery
                Subject: Infectious Disease

                Keywords: traumatic wound,surgical wound,contamination,non-healing wound,contaminated wound,wound healing,usp <51> antimicrobial effectiveness testing,electrospinning,synthetic electrospun fiber matrix,extracellular matrix
                Data availability:
                Keywords: traumatic wound, surgical wound, contamination, non-healing wound, contaminated wound, wound healing, usp <51> antimicrobial effectiveness testing, electrospinning, synthetic electrospun fiber matrix, extracellular matrix

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