title: A multicenter, prospective, clinical trial evaluating a novel adhesive baseplate (Provox StabiliBase) for peristomal attachment of postlaryngectomy pulmonary and voice rehabilitation devices.
abstract: OBJECTIVE
  Assessment of a novel adhesive baseplate (Provox StabiliBase) for heat and moisture exchanger (HME) and/or automatic speaking valve (ASV) application.
  
  
  METHODS
  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.
authors.affiliation: Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Nijmegen, the Netherlands. f.hilgers@nki.nl
authors.forename: Frans J M
authors.initials: FJ
authors.lastname: Hilgers
authors.forename: Richard
authors.initials: R
authors.lastname: Dirven
authors.forename: Yannick
authors.initials: Y
authors.lastname: Wouters
authors.forename: Irene
authors.initials: I
authors.lastname: Jacobi
authors.forename: Henri A M
authors.initials: HA
authors.lastname: Marres
authors.forename: Michiel W M
authors.initials: MW
authors.lastname: van den Brekel
mesh_terms: D000368:Aged; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D007825:Laryngectomy; D007831:Larynx, Artificial; D008297:Male; D017060:Patient Satisfaction; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011788:Quality of Life; D013071:Speech, Alaryngeal / Q000295:instrumentation*; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D014014:Tissue Adhesives; D016896:Treatment Outcome; D014833:Voice Quality
chemical_list: D014014:Tissue Adhesives