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

Authors

  • Frans J. M. Hilgers MD, PhD,

    Corresponding author
    1. Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital, Nijmegen, the Netherlands
    2. Institute of Phonetic Sciences, University of Amsterdam, Nijmegen, the Netherlands
    3. Department of Otorhinolaryngology, Academic Medical Center University of Amsterdam, Nijmegen, the Netherlands
    • Netherlands Cancer Institute, Plesmanlaan 121, 1066CX, Amsterdam, the Netherlands
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  • Richard Dirven MD,

    1. Department of Otorhinollaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
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  • Yannick Wouters MD,

    1. Department of Otorhinollaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
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  • Irene Jacobi PhD,

    1. Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital, Nijmegen, the Netherlands
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  • Henri A. M. Marres MD, PhD,

    1. Department of Otorhinollaryngology-Head and Neck Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
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  • Michiel W. M. van den Brekel MD, PhD

    1. Department of Head and Neck Oncology and Surgery, Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital, Nijmegen, the Netherlands
    2. Institute of Phonetic Sciences, University of Amsterdam, Nijmegen, the Netherlands
    3. Department of Otorhinolaryngology, Academic Medical Center University of Amsterdam, Nijmegen, the Netherlands
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  • This study was conducted in the Department of Head and Neck Oncology and Surgery of the Netherlands Cancer Institute under an unrestricted research grant from the manufacturer of the tested adhesives (Atos Medical AB, Hörby, Sweden). The Radboud University Medical Center received financial compensation from the manufacturer at fair market value for the time involved in data collection activities. Patients received all necessary adhesives for the duration of the study and received reimbursement for travel expenses from the manufacturer.

  • The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Abstract

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

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