title: Topical mitomycin application after laryngotracheal reconstruction: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To explore the effect of mitomycin treatment on the pediatric airway following laryngotracheal reconstruction.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled trial.
  
  
  METHODS
  Children aged 2 to 17 years with subglottic or upper tracheal stenosis undergoing laryngotracheal reconstruction at a single, tertiary care, children's hospital.
  
  
  METHODS
  At the time of extubation or stent removal, the children underwent bronchoscopy and 0.4 mg/mL (2 mL of a 0.2-mg/mL solution of either mitomycin or an equal volume of isotonic sodium chloride was directly applied to the subglottic region for a single application of 2 minutes. These children then underwent interval endoscopy at 2 weeks, 6 weeks, and 3 months postoperatively for assessment of their airways.
  
  
  RESULTS
  Granulation tissue was graded on a scale of 0 (none) to 4 (near-total or total occlusion). Videotapes of endoscopies were independently observed and graded by 3 pediatric otolaryngology fellows with a subsequent interobserver agreement of 91.6%. The results were then dichotomized to represent a single cohort in which further surgical intervention would be required and another separate cohort in which further surgery would not be required. At the 1-year mark, interim analysis was performed by a Data Safety and Monitoring Committee. At this time, 13 children had been randomized to the mitomycin-treated arm of the study and 11 children to the placebo-treated arm. A 2-tailed Fisher exact test revealed a value of 1.00. The Data Monitoring and Safety Committee advised that the trial should be stopped because the distributions between the 2 populations were almost identical.
  
  
  CONCLUSIONS
  We cannot reject the null hypothesis that a single topical dose of mitomycin exerts an equal benefit as does isotonic sodium chloride when applied to the pediatric airway after laryngotracheal reconstruction.
authors.affiliation: Department of Pediatric Otolaryngology, Children's Hospital Medical Center, Cincinnati, Ohio, USA. christopher_hartnick@meei.harvard.edu
authors.forename: C J
authors.initials: CJ
authors.lastname: Hartnick
authors.forename: B E
authors.initials: BE
authors.lastname: Hartley
authors.forename: P D
authors.initials: PD
authors.lastname: Lacy
authors.forename: J
authors.initials: J
authors.lastname: Liu
authors.forename: J A
authors.initials: JA
authors.lastname: Bean
authors.forename: J P
authors.initials: JP
authors.lastname: Willging
authors.forename: C M
authors.initials: CM
authors.lastname: Myer
authors.forename: R T
authors.initials: RT
authors.lastname: Cotton
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D006801:Humans; D007829:Laryngostenosis / Q000601:surgery*; D007830:Larynx / Q000601:surgery*; D016685:Mitomycin / Q000008:administration & dosage*; D019384:Nucleic Acid Synthesis Inhibitors / Q000008:administration & dosage*; D019651:Plastic Surgery Procedures; D014132:Trachea / Q000601:surgery*; D014135:Tracheal Stenosis / Q000601:surgery
chemical_list: D019384:Nucleic Acid Synthesis Inhibitors; D016685:Mitomycin