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  • Online Resource  (2)
  • Bay, Lene  (2)
  • Bengtsson, Henrik  (2)
  • 2020-2024  (2)
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  • Online Resource  (2)
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  • 2020-2024  (2)
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  • 1
    In: APMIS, Wiley, Vol. 130, No. 7 ( 2022-07), p. 404-416
    Abstract: Needle reuse is a common practice and primary cause of customer compliance issues such as pain, bruising, clogging, injection site reactions (ISR), and associated lipodystrophy. This study aimed to characterize skin microflora at injection sites and establish microbial contamination of used pen injectors and needles. The second objective was to evaluate the risk of infections during typical and repeated subcutaneous injections. 50 participants with diabetes and 50 controls (n = 100) were sampled through tape strips and skin swabs on the abdomen and thigh for skin microflora. Used pen injectors and needles were collected after  in‐home  use and from the hospital after drug administration by health care professionals (HCPs). Samples were analyzed by conventional culture, matrix‐assisted laser desorption/ionization‐time of flight (MALDI‐TOF), mass spectrometry (MS), confocal laser scanning microscopy (CLSM), and 16S/ITS high throughput sequencing (HTS). A mathematical model simulated the risk of needle contamination during injections. Injection site populations were in 10 2  cells/cm 2  order, with increased viable bacteria and anaerobic bacteria on the skin in persons with diabetes (p = 0.05). Interpersonal variation dominated other factors such as sex or location. A higher prevalence of  Staphylococcus aureus  on abdominal skin was found in persons with diabetes than control skin (p ≤ 0.05). Most needles and cartridges (95% and 86%) contained no biological signal. The location of the device collection (hospital vs home‐use) and use regimen did not affect contamination. CLSM revealed scarcely populated skin microflora scattered in aggregates, diplo, or single cells. Our mathematical model demonstrated that penetrating bacteria colonies during subcutaneous injection is unlikely. These findings clarify the lack of documented skin infections from subcutaneous insulin injections in research. Furthermore, these results can motivate the innovation and development of durable, reusable injection systems with pharmacoeconomic value and a simplified and enhanced user experience for patients.
    Type of Medium: Online Resource
    ISSN: 0903-4641 , 1600-0463
    URL: Issue
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2098213-6
    SSG: 12
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  • 2
    In: Laboratory Animals, SAGE Publications, Vol. 57, No. 3 ( 2023-06), p. 304-318
    Abstract: Pig skin is commonly used in the medical industry as an injection model due to its compelling physiological affinity to human skin. However, the pig neck skin microflora remains largely uncharacterized, which may have undesirable implications for the translatability of results to humans. This study aimed to characterize pig neck skin microbiome with direct comparison with human skin microflora at emblematic injection sites to appraise its suitability as an injection model. Ten minipigs were sampled with tape strips and swabs and analysed by matrix-assisted laser desorption/ionization-time of flight mass spectrometry and 16S/ITS high throughput sequencing and confocal laser scanning microscopy. Results were directly compared with previous investigations of human injection sites. Pig skin was dominated by phyla 94.8% Firmicutes, 3% Proteobacteria, and 2.2% Actinobacteria. Staphylococcus spp. prevailed (44.4%) at the genus level with S. capitis and S. chromogenes present in all samples. Pig skin revealed populations in the 10 4 colony-forming units (CFU)/cm 2 range with 3% identified as Gram-negative and increased alpha diversity (compared with 10 2 CFU/cm 2 and 10% in humans). While notable taxonomical differences on species levels were seen, pig skin encompassed 97.1% of genera found in human samples. The increased population and variation found support the pig neck as an imperfect but fidelitous subcutaneous injection model that can adequately challenge devices from a microbial standpoint.
    Type of Medium: Online Resource
    ISSN: 0023-6772 , 1758-1117
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2036511-1
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