title: A new custom moldable external neck brace (ENB 2.0) to improve hands-free speech in laryngectomized patients.
abstract: OBJECTIVE
  The majority of laryngectomy patients fail to use a hands-free valve on a daily basis, mainly due to fixation problems of the adhesive baseplate housing. To support adhesive housings during hands-free speech a new external neck brace (ENB 2.0) was developed. The effect of the brace was assessed in terms of a qualitative assessment, adhesive lifetime, maximum phonation time and patient self-reports.
  
  
  METHODS
  Twenty laryngectomees participated in this randomized, prospective, crossover trial.
  
  
  METHODS
  All participants used the Provox hands-free HME valve with an Xtrabase adhesive for 1 month, 2 weeks with an ENB 2.0, and 2 weeks without. Outcomes were compared with the previous model of the external neck brace (ENB 1.0).
  
  
  RESULTS
  The average total number of adhesive baseplates used during the trial was 16.7 in the non-brace group versus 10.9 in the brace group (P = 0.05). The number of daily replacements was 1.4 in the non-brace group and 1.1 in the brace group (P = 0.025). The average time a hands-free valve was worn per baseplate was 9.5 hours when wearing a neck brace versus 7.3 hours without brace (P = 0.09).The majority (81%) of the patients considered the neck brace 2.0 as a welcome addition to improve hands-free speech after laryngectomy and would use it if prescribed (88%).
  
  
  CONCLUSIONS
  The new model of the neck brace reduces the number of baseplate replacements during hands-free speech and is considered as a helpful device by 81% of the participants.
authors.affiliation: Department of Otorhinolaryngology/Head and Neck Surgery, Radboud University Nijmegen Medical Centre, Nijmegen.
authors.forename: Richard
authors.initials: R
authors.lastname: Dirven
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Clark
authors.forename: Joris G F
authors.initials: JG
authors.lastname: Wismans
authors.forename: John
authors.initials: J
authors.lastname: McGuiness
authors.forename: Carsten E
authors.initials: CE
authors.lastname: Palme
authors.forename: Katrina
authors.initials: K
authors.lastname: Blyth
authors.forename: Candice
authors.initials: C
authors.lastname: Baxter
authors.forename: Danielle B
authors.initials: DB
authors.lastname: Stone
authors.forename: Henri A M
authors.initials: HA
authors.lastname: Marres
mesh_terms: D000368:Aged; D001915:Braces; D018592:Cross-Over Studies; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000601:surgery; D007825:Laryngectomy / Q000379:methods; D007831:Larynx, Artificial; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009333:Neck; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D018583:Pliability; D011446:Prospective Studies; D011788:Quality of Life; D013071:Speech, Alaryngeal / Q000295:instrumentation*; D018709:Statistics, Nonparametric; D014014:Tissue Adhesives; D016896:Treatment Outcome
chemical_list: D014014:Tissue Adhesives
keywords: External neck brace; adhesive lifetime; custom moldable; hands-free speech; hands-free valve; total laryngectomy; tracheoesophageal speech