Clinical use of a voice prosthesis with a flap valve containing silver oxide (Blom-Singer Advantage), biofilm formation, in-situ lifetime and indication

BACKGROUND: Fungal growth and the resulting leakage through an indwelling voice prosthesis remains the most frequent reason of prosthesis failure and renewal. In some patients leakage caused by fungal growth occurs in very short intervals (below 12 weeks in-situ lifetime) and causes frequent treatments and high costs. METHODS: The Blom-Singer(R) Advantage voice prosthesis is a new prosthesis type with a modified flange design, a flap valve containing 7 % silver oxide in the silicon matrix and is expected to be resistant against biofilm formation and fungal growth. PATIENTS: In a clinical trial we used the Blom-Singer(R) Advantage prosthesis in 33 patients with short in-situ lifetimes of their voice prosthesis and analysed the effects on in-situ lifetime and complications statistically. RESULTS: The clinical use of the Blom-Singer(R) Advantage prosthesis was similar to other types of indwelling voice prosthesis (Provox(R) II, Blom-Singer Indwelling(R)) and did not cause any special problems. Prosthesis specific side effects (i. e. allergy against silver oxide) did not occur. Statistical analysis of the aquired data showed an interindividually changing, but significantly longer in-situ lifetime for the Blom-Singer(R) Advantage prosthesis. The mean device lifetime increased from 36 days (median 36 days) to a mean lifetime of 110 days (median 87 days) with the use of the Blom-Singer(R) Advantage prosthesis. CONCLUSIONS: Using a voice prosthesis with a valve containing silver oxide can normalize and even increase the in-situ lifetime in patients with frequent changing procedures caused by fungal growth on the valve. Therefore we recommend the use of this type of voice prosthesis for those patients as reduction of costs and effort results.