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.