OBJECTIVES/HYPOTHESIS: Time of adherence of adhesive baseplate housings to the neck of a laryngectomized patient is one of the main problems that account for the low number of laryngectomy patients who benefit from hands-free speech. An external neck brace (ENB 1.0) was introduced to support peristomal fixation of adhesive baseplates. STUDY DESIGN: A prospective randomized controlled clinical cross-over trial. METHODS: A total of 28 laryngectomy patients participated in this randomized, prospective, crossover trial. All used the Provox hands-free heat and moisture exchanger (HME) valve for 1 month: 2 weeks with an ENB and 2 weeks without. RESULTS: The median lifetime of an adhesive baseplate without a brace was 52.5 minutes versus 210 minutes with a brace (P = .03). Four participants considered the ENB as "a little" bit of a welcome addition, nine as "quite a bit," and six as "very much" (79%) to improve hands-free speech. CONCLUSIONS: The ENB significantly increases the lifetime of an adhesive baseplate and therefore contributes to achieving hands-free speech for a greater number of patients with laryngectomy.
RCT Entities:
OBJECTIVES/HYPOTHESIS: Time of adherence of adhesive baseplate housings to the neck of a laryngectomized patient is one of the main problems that account for the low number of laryngectomy patients who benefit from hands-free speech. An external neck brace (ENB 1.0) was introduced to support peristomal fixation of adhesive baseplates. STUDY DESIGN: A prospective randomized controlled clinical cross-over trial. METHODS: A total of 28 laryngectomy patients participated in this randomized, prospective, crossover trial. All used the Provox hands-free heat and moisture exchanger (HME) valve for 1 month: 2 weeks with an ENB and 2 weeks without. RESULTS: The median lifetime of an adhesive baseplate without a brace was 52.5 minutes versus 210 minutes with a brace (P = .03). Four participants considered the ENB as "a little" bit of a welcome addition, nine as "quite a bit," and six as "very much" (79%) to improve hands-free speech. CONCLUSIONS: The ENB significantly increases the lifetime of an adhesive baseplate and therefore contributes to achieving hands-free speech for a greater number of patients with laryngectomy.