R. Vanweissenbruch et al., CHEMOPROPHYLAXIS OF FUNGAL DETERIORATION OF THE PROVOX SILICONE TRACHEOESOPHAGEAL PROSTHESIS IN POSTLARYNGECTOMY PATIENTS, The Annals of otology, rhinology & laryngology, 106(4), 1997, pp. 329-337
A double-blind randomized trial was conducted among 36 laryngectomees
to assess the influence of a buccal bioadhesive slow-release tablet co
ntaining miconazole nitrate on the lifetime of the Provox voice prosth
esis. All patients colonized with Candida spp and treated with miconaz
ole showed a significant decrease of colonization at the end of the st
udy. Intratracheal phonatory pressures were remarkably higher after 2
months of follow-up in the placebo group. No local or systemic adverse
reactions to miconazole were observed during this study. Patient comp
liance was acceptable according to regular miconazole determination in
saliva samples. The device lifetime was significantly higher in patie
nts treated with miconazole even after 1 year of follow-up. The use of
a buccal bioadhesive slow-release tablet containing an antimycotic ag
ent proves to be an adequate method of preventing fungal colonization
and deterioration of silicone voice prostheses.