A multicenter, prospective, clinical trial evaluating a novel adhesive baseplate (Provox StabiliBase) for peristomal attachment of postlaryngectomy pulmonary and voice rehabilitation devices

摘要

Objectives/Hypothesis: Assessment of a novel adhesive baseplate (Provox StabiliBase) for heat and moisture exchanger (HME) and/or automatic speaking valve (ASV) application. Study Design: Prospective, clinical, multicenter trial. Methods: This was a trial in laryngectomized patients comparing their usual adhesive with the trial adhesive. Primary outcome measure was overall patient preference; additional outcome parameters possibly explaining patients' preferences were 1) patient tolerance and preference with respect to daily handling of the adhesive; 2) adhesive lifespan, and 3) voice and speech with the adhesives. Study specific questionnaires, visual analog scales, patients' diaries, and stoma assessments were used for data collection. Results: In total, 58 of the 65 laryngectomized individuals entered in the study completed the trial. Patients' overall preference for the new device was high (76%; P <.001). Significantly better performance was found for the trial adhesive with respect to ease of application (P =.034), fit (P <.001), and air leakage through the adhesive (P <.001). Comfort and stoma depth correlated weakly (r = 0.297; P =.024; deeper stoma-more comfort with StabiliBase). The adhesive lifespan with HME is significantly increased (1.7 times and 15.7 hours-plus airtight use; P <.001). This longer lifespan coincided with somewhat increased dirtying of the adhesive (P =.02). There were no serious adverse events. Conclusions: The StabiliBase adhesive for peristomal attachment of HMEs and/or ASVs was preferred by 76% of study participants and showed a promising prolonged lifespan. This new device further increases the options for stoma attachment in laryngectomized individuals, and subsequently the availability of optimal voice and pulmonary rehabilitation for a larger proportion of patients. Laryngoscope, 2012