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

Hilgers, Frans J. M.; Dirven, Richard; Wouters, Yannick; Jacobi, Irene; Marres, H.A.M.; Brekel, Michiel W. M. van den

doi:10.1002/lary.23469

Cited by 10 publications

(23 citation statements)

References 20 publications

(27 reference statements)

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“…Hilgers et al . evaluated patients' experiences with a novel adhesive and four questions that were used in this study were selected from this publication. A fifth question was added and asked whether the patient had used an adhesive.…”

Section: Methodsmentioning

confidence: 99%

“…Total laryngectomy causes significant anatomical changes that interfere with normal physiological processes. Separating the alimentary and respiratory tracts with the creation of a permanent stoma at the base of the neck precludes normal pulmonary driven voice and speech, and lack of a nasal airflow leads to olfaction and pulmonary problems . To reduce pulmonary symptoms, such as involuntary coughing and excessive phlegm production, patients normally use a heat and moisture exchanger (HME).…”

mentioning

confidence: 99%

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Patients' experiences with HMEs and attachments after total laryngectomy

Macrì

Bogaardt

Parrilla

et al. 2016

Clinical Otolaryngology

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Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

Patients' experiences with HMEs and attachments after total laryngectomy

Macrì

Bogaardt

Parrilla

et al. 2016

Clinical Otolaryngology

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“…The SBO consists of a stable base, similar to that of the SB, but with a hydrocolloid adhesive. 9 The patch is suitable for sensitive and/or breached skin and its baseplate is designed to also accommodate deep tracheostomas.…”

Section: Methodsmentioning

confidence: 99%

“…Based on earlier studies and given the assumption that in the absence of irritation, the duration of the seal is the deciding factor, this was a feasible goal to be expected and clinically relevant. 9 10 12 A sample size of 30 pairs will have 82% of power to detect a difference in proportions of 0.350, while the proportion of discordant pairs is expected to be 0.450, using a sign test of equality of paired proportions with a 0.05 two-sided level of significance. As this was a short study and no risks have been associated with participation in the study, the dropout rate was expected to be < 5%.…”

Section: Methodsmentioning

confidence: 99%

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Comparative Study Between Peristomal Patches in Patients with Definitive Tracheostomy

Lansaat

Kleijn

Hilgers

et al. 2017

Int Arch Otorhinolaryngol

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Introduction To prevent or diminish pulmonary problems in laryngectomized patients, continuous use of a heat and moisture exchanger (HME) is recommended. Therefore, automatic speaking valves are also often combined with an HME to enable hands-free speech. In order to keep these devices in place, most commonly, peristomal patches are used. Objective This prospective clinical 2 × 2 crossover study aims at assessing the added value of a new patch for HME application, the Provox StabiliBase OptiDerm (SBO). The device combines the stable and conical base of the Provox StabiliBase with the skin-friendlier hydrocolloid Provox OptiDerm (OD) patch. Methods Thirty-two laryngectomized patients were included in this multicenter study. Participants were asked to compare SBO to OD, and to the patch they normally use. The primary outcome measure was patient preference. Results Overall, 60% of the participants had preference for their normally used patch, 23% preferred the SBO and 17% indicated no preference. When comparing the SBO to the OD, 43% preferred the SBO, 40% the OD and 17% had no preference. Conclusion Most patients preferred their normally used patch and SBO was favored by a subgroup. Provox StabiliBase OptiDerm seems to be a valuable addition to the existing patches and further increases patients' options for HME application.

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Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

et al. 2019

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ObjectivesThe aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malmö, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects.MethodsThis was a multicenter randomized crossover trial conducted in the Netherlands Cancer Institute, Erasmus Medical Center, and Maastricht University Medical Center in The Netherlands. The study included 46 laryngectomized subjects with prior heat and moisture exchanger (HME) and adhesive experience.ResultsA significant improvement in the number of compliant individuals was found: Luna: n = 43 of 45 (96%); usual care: n = 35 of 46 (76%), P = 0.02. The Luna period was associated with longer intervals of daily HME use (Luna 23.2 hours [range: 15.6–24.0 hours], usual care [UC]: 21.5 hours [range: 6.0–24.0 hours], P = 0.003) and an increased frequency of skin improvement overnight (Luna 3.9 days [standard deviation (SD)]: 7.0 days), Usual Care: 8.1 days ([SD: 10.8 days], P = 0.008). Fifty‐six percent (n = 26) of participants wanted to continue using the Provox Luna system at the conclusion of the study.ConclusionAn improvement in compliance and skin recovery overnight was observed when the Provox Luna was added to the usual adhesive and HME use. Therefore, there is utility in supplementing the usual post‐total laryngectomy care with the Provox Luna system at night, particularly in the setting of compliance concerns and in subjects who desire dermatological relief overnight.Level of Evidence1b Laryngoscope, 129:2354–2360, 2019

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

Cited by 10 publications

References 20 publications

Patients' experiences with HMEs and attachments after total laryngectomy

Patients' experiences with HMEs and attachments after total laryngectomy

Comparative Study Between Peristomal Patches in Patients with Definitive Tracheostomy

Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

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