title: Evaluation of prophylaxis treatment of Candida in alaryngeal patients with tracheoesophageal voice prostheses.
abstract: OBJECTIVE
  The 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.
  
  
  METHODS
  Randomized, unblinded, crossover trial.
  
  
  METHODS
  Twenty-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.
  
  
  RESULTS
  Fifteen 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).
  
  
  CONCLUSIONS
  Nystatin 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.
  
  
  METHODS
  1b
authors.affiliation: Milton J. Dance, Jr. Head and Neck Center, Baltimore, Maryland, U.S.A.
authors.forename: Barbara P
authors.initials: BP
authors.lastname: Messing
authors.forename: Melissa
authors.initials: M
authors.lastname: Kim
authors.forename: Richard
authors.initials: R
authors.lastname: Hirata
authors.forename: Carol B
authors.initials: CB
authors.lastname: Thompson
authors.forename: Samantha
authors.initials: S
authors.lastname: Gebhart
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Sugar
authors.forename: John M
authors.initials: JM
authors.lastname: Saunders
authors.forename: James
authors.initials: J
authors.lastname: Sciubba
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Califano
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D002175:Candida / Q000302:isolation & purification*; D002177:Candidiasis / Q000382:microbiology / Q000517:prevention & control; D018592:Cross-Over Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007825:Laryngectomy / Q000534:rehabilitation*; D007831:Larynx, Artificial; D008297:Male; D016459:Prosthesis-Related Infections / Q000382:microbiology / Q000517:prevention & control*; D012189:Retrospective Studies; D013072:Speech, Esophageal / Q000295:instrumentation*
chemical_list: D000900:Anti-Bacterial Agents
keywords: Biotène® mouthwash; Candida; laryngectomy; nystatin; tracheoesophageal voice prosthesis