• Barbara P Messing, Melissa Kim, Richard Hirata, Carol B Thompson, Samantha Gebhart, Elizabeth A Sugar, John M Saunders, James Sciubba, and Joseph A Califano.
• Milton J. Dance, Jr. Head and Neck Center, Baltimore, Maryland, U.S.A.
• Laryngoscope. 2015 May 1; 125 (5): 1118-23.

Objectives/HypothesisThe objective of this study was to evaluate the effectiveness of nystatin and Biotène(®) mouthwash Oral Rinse for controlling Candida in total laryngectomy (TL) patients with a tracheosophageal voice prosthesis (TEP) because Biotène(®) mouthwash Oral Rinse is a less costly alternative to nystatin and requires less adherence time.Study DesignRandomized, unblinded, crossover trial.MethodsTwenty-one TL patients were randomized to receive nystatin followed by Biotène(®) mouthwash Oral Rinse, or the reverse order, after a basic oral-care phase (i.e., brushing teeth, cleaning dentures). A Provox(®) 2, 22.5 French TEP, which is an indwelling silicone voice prosthesis, was placed at the beginning of each phase. Patients were provided with oral care instructions at randomization and medication-specific instructions with each treatment's initiation. TEPs were processed and evaluated for Candida growth as colony-forming units (CFUs). Wilcoxon signed-rank tests were used for comparisons between treatments.ResultsFifteen patients were available for comparisons of Candida counts (6 received nystatin; 9 received Biotène(®) mouthwash first). Overall, the median log10 (CFUs) remained high regardless of treatment (no medication: 8.9; nystatin: 8.7; Biotène(®) mouthwash: 8.4). However, the median counts for both nystatin and Biotène(®) mouthwash Oral Rinse were lower than those for no medication (difference [Δ]:-0.9 and -0.3, respectively), although only nystatin was significantly lower (P = 0.02). There was no significant difference between the two treatments (P = 0.22). Overall, median medication-adherence was high (97%), and Biotène(®) mouthwash adherence was significantly higher than that of nystatin (Δ: 7.6%; P = 0.03).ConclusionNystatin and Biotène(®) mouthwash Oral Rinse had similar CFU levels, with nystatin showing a significant improvement over usual oral care. Biotène(®) mouthwash is a less costly alternative to nystatin, with a less complex treatment protocol that might make it preferable to patients and clinicians.Level Of Evidence1b© 2014 The American Laryngological, Rhinological and Otological Society, Inc.

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