Background: The aim of the study was to investigate the decontamination of human donor larynx (tissue-engineered for laryngeal replacements) with medical device BASE.128 (ALCHIMIA S.r.l) in comparison with standard decontamination procedure.
Methods: Laryngeal tissues from two donors were divided in halves and decontaminated with BASE.128 at 22°C and BASE.128 at 37°C overnight. The control halves of both tissues were disinfected with standard procedure using 20% chlorhexidine for 5 minutes at room temperature. Tissues were tested microbiologically, and any microorganism still present at the end of the process was isolated and further investigated in BASE.128 time-kill studies at 37°C.
Results: Standard chlorhexidine disinfection procedure and decontamination with BASE.128 at 22°C overnight resulted inefficient in elimination of C. albicans and S. oralis from the first donor larynx.
However, the time-kill studies showed 5-6 log elimination of both isolated strains, after treatment with BASE.128 at 37°C for 6h.
The second tissue, initially contaminated by Citrobacter koseri, was completely decontaminated by BASE.128 at 37°C overnight, while it still resulted contaminated after standard disinfection with 20% chlorhexidine.
Conclusion: An overnight decontamination with BASE.128 at 37°C was effective in decontaminating laryngeal tissue. More tissues will be tested in order to confirm the results and validate the procedure.
Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and human tissue banking with the aim of improving the daily routine of the medical personnel and the quality of life of patients.
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