Site References

  1. Please refer to the package insert – Instructions for Use (IFU).
  2. U.S. Food and Drug Administration. 510(k) Summary K211943: Microlyte Ag/Lidocaine Wound Dressing. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211943.pdf
  3. Field, F. K., & Kerstein, M. D. (1994). Overview of wound healing in a moist environment. American journal of surgery, 167(1A), 2S–6S. https://doi.org/10.1016/0002-9610(94)90002-7
  4. Okan, D., Woo, K., Ayello, E. A., & Sibbald, G. (2007). The role of moisture balance in wound healing. Advances in skin & wound care, 20(1), 39–55. https://doi.org/10.1097/00129334-200701000-00013
  5. Agarwal, A. et al. (2010). Surfaces modified with nanometer-thick silver-impregnated polymeric films that kill bacteria but support growth of mammalian cells. Biomaterials, 31(4), 680-690. https://doi.org/10.1016/j.biomaterials.2009.09.092
  6. Manning, S. W. et al. (2020). Efficacy of a Bioresorbable Matrix in Healing Complex Chronic Wounds: An Open-Label Prospective Pilot Study. Wounds: a compendium of clinical research and practice, 32(11), 309–318. Available at: https://pubmed.ncbi.nlm.nih.gov/33465043/
  7. Chatelain R. (2021). The Efficacy of a Novel Silver-Containing Bioresorbable Microfilm Matrix in At-Risk Surgical Wounds: A Clinical Case Series. Wounds: a compendium of clinical research and practice, 33(10), 245–252. Available at: https://pubmed.ncbi.nlm.nih.gov/34735361/
  8. Measurement of Antimicrobial Activity of Microlyte Ag, Study 16C_52935_02, 2016. Data on file, Imbed Biosciences.
  9. Study 15T_41113_02, Systemic Toxicity, Local Tissue Response, and Wound Healing Study of Microlyte Ag, Following Repeated Treatment to Full-Thickness Wounds in Rats – 28 Days. Data on file, Imbed Biosciences.
  10. Study 15-002, Microlyte Shelf Life and Stability. Data on file, Imbed Biosciences.
  11. MTT cytotoxicity testing conduct at NAMSA. Data on file, Imbed Biosciences.
  12. Water absorption capacity, water vapor transmission rate, oxygen transmission rate. Data on file in the 510k application.
  13. Biocompatibility has been demonstrated through appropriate in vitro and in vivo tests, including: cytotoxicity, skin sensitization, acute intracutaneous reactivity, acute systemic toxicity, sub-chronic/sub-acute systemic toxicity, and tissue implantation tests. All tests were performed in compliance with GLP regulations in accordance with ISO 10993-1, Biological evaluations of medical devices part 1: evaluation and testing. The results indicate that the subject device passed toxicity and safety tests and is safe for intended use. Data on file in the 510k application.
  14. Sustained antimicrobial activity for up to 3 days has been demonstrated by relevant standard in vitro microbiological assays in simulated wound fluid. The matrix was shown to be effective in reducing on its surface more than 4 log10 CFUs of a broad spectrum of microbes most frequently associated with wound infections, including, Staphylococcus aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 10231), Klebsiella pneumoniae (ATCC 4352), Candida tropicalis (ATCC 750), and Candida albicans (ATCC 10231). The product was determined as being non-pyrogenic. Data on file in the 510k application and at Imbed Biosciences. Data on file at Imbed Biosciences.
  15. Establishment Registration & Device Listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=510117&lpcd=FRO 
  16. Inactive Ingredient Search for Approved Drug Products: https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm?event=BasicSearch.page.
  17. https://www.govinfo.gov/content/pkg/FR-2022-11-23/pdf/2022-23918.pdf – See Table 62 on Page 71982 (Rules and Regulations, Federal Register, Vol 87, No. 225, Nov 23, 2022).
  18. 19-01 Report, Silver-Lidocaine Release Profiles of Microlyte Ag/Lidocaine Wound Dressing (DOC-907). Data on file, Imbed Biosciences.
  19. Berríos-Torres, S. et al. (2017). Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. JAMA Surg, 152(8), 784-791.https://doi.org/10.1001/jamasurg.2017.0904
  20. Gan, T. J., Habib, A. S., Miller, T. E., White, W., & Apfelbaum, J. L. (2013). Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Current Medical Research and Opinion, 30(1), 149–160. https://doi.org/10.1185/03007995.2013.860019
  21. Gauglitz, G. G., Shahrokhi, S., Williams, F. N. Burn wound infection and sepsis. UpToDate. https://www.uptodate.com/contents/burn-wound-infection-and-sepsis
  22. Turissini, J. D., Elmarsafi, T., Evans, K. K., & Kim, P. J. (2019). Major Risk Factors Contributing to Split Thickness Skin Graft Failure. Georgetown Medical Review, 3(1). https://doi.org/10.52504/001c.7755
  23. Høgsberg, T., Bjarnsholt, T., Thomsen, J. S., & Kirketerp-Møller, K. (2011). Success rate of split-thickness skin grafting of chronic venous leg ulcers depends on the presence of Pseudomonas aeruginosa: a retrospective study. PloS one, 6(5), e20492. https://doi.org/10.1371/journal.pone.0020492
  24. Abdulmughni, L. A., Al-Sanabani, J. A., Gilan, W. M., Issa, M. A., & Jowah, H. M. (2025). Split-thickness skin graft outcomes and associated risk factors in patients with skin defects at Al-Gumhouri hospital, Sana’a, Yemen: a prospective observational study. BMC surgery, 25(1), 292. https://doi.org/10.1186/s12893-025-03021-5
  25. Hanson-Viana E, Rojas-Ortiz JA, Rendón-Medina MA, Luna-Zepeda BL. (2024). Bacterial fluorescence imaging as a predictor of skin graft integration in burn wounds. Burns, 50(7),1799-1811. https://doi.org/10.1016/j.burns.2024.04.003
  26. Kornhaber, R., Mc Kittrick, A., Rossiter, R., & Cleary, M. (2025). Pain Experiences in Adult Burn Survivors During Rehabilitation and Recovery: A Qualitative Systematic Review. Journal of Burn Care & Research, iraf031. https://doi.org/10.1093/jbcr/iraf031
  27. LIDOCAINE HYDROCHLORIDE – lidocaine injection, solution: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0c0790ec-effd-4d8a-9874-8ca0b31e54d0&type=display

† As demonstrated in vitro.