Microbial colonization of tracheostoma region in patients with voice prostheses - double-blind randomized clinical trial

Tracheoesophageal puncture (TEP) with voice prosthesis (VP) insertion is standard procedure to restore speech after total laryngectomy. Microbial colonization on VPs leads to various complications. The aim of this study was to evaluate the microbiome colonization in tracheoesophageal fistulas as potential factors reducing the longevity of VPs and to compare the impact of the care regimens for laryngectomized patients on the microbiome. A total of 52 patients who underwent laryngectomy with primary TEP and VP insertion were included and randomly assigned to two groups: the regular exchange arm (REA) and the leakage exchange arm (LEA). Two separate swabs, one from the trachea and the other one from the tracheoesophageal fistula, were collected at the time of VP replacement. Fistula swab cultures showed bacterial colonization in 98.1% of cases, with Staphylococcus aureus being the most commonly identified bacterium (51.9%). Yeast colonization was present in 40.4% of fistula swabs, with Candida species identified. Tracheal swabs yielded positive bacterial cultures in 92.3% samples and fungal in 19.2%. The most commonly cultured bacterium was Staphylococcus aureus (51.9%), and the most common fungus was the genus Candida (100%). None of the identified microbiological factors significantly differentiated patients based on the regularity of VP replacement (p = 0.603-1). The identified bacteria and fungi were similar regardless of complications, comorbidities or adjuvant treatment. Bacteria and yeast were identified in almost all swabs from tracheoesophageal fistula and trachea of laryngectomized patients with VPs. A frequent co-colonization of bacteria and fungi was observed, with Candida albicans and Staphylococcus aureus being the most common. Follow-up of patients with VP, including the regularity of VP replacements, should not be dependent on microbial colonization of the fistula or trachea.