Leemans Maartje, Longobardi Ylenia, Dirven Richard, Honings Jimmie, D'Alatri Lucia, Galli Jacopo, van den Brekel Michiel, Parrilla Claudio, van Sluis Klaske E
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
UOC di Otorinolaringoiatria, Dipartimento di Scienza dell'invecchiamento, neurologiche, ortopediche e della testa-collo, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Laryngoscope. 2023 Nov;133(11):2965-2970. doi: 10.1002/lary.30636. Epub 2023 Mar 8.
This study aims to assess the product performance of a new moldable peristomal adhesive with corresponding heating pad designed to facilitate and improve automatic speaking valve (ASV) fixation for hands-free speech in laryngectomized patients.
Twenty laryngectomized patients, all regular adhesive users with prior ASV experience, were included. Study-specific questionnaires were used for data collection at baseline and after two weeks of moldable adhesive use. The primary outcome parameters were adhesive lifetime during hands-free speech, use and duration of hands-free speech, and patient preference. Additional outcome parameters were satisfaction, comfort, fit, and usability.
The moldable adhesive enabled ASV fixation adequate for hands-free speech in the majority of participants. Overall, the moldable adhesive significantly increased adhesive lifetime and duration of hands-free speech compared to participants' baseline adhesives (p < 0.05), regardless of stoma depth, skin irritation, or regular use of hands-free speech at baseline. The participants who preferred the moldable adhesive (55% of participants) experienced a significant increase in the adhesive lifetime (median of 24 h, range 8-144 h) and improved comfort, fit, and ease of speech.
The moldable adhesive's lifetime and functional aspects, including the ease of use and custom fit, are encouraging outcomes and enable more laryngectomized patients to use hands-free speech more regularly.
4 Laryngoscope, 133:2965-2970, 2023.
本研究旨在评估一种新型可塑形造口周围粘合剂及其配套加热垫的产品性能，该产品旨在促进和改善喉切除患者免提讲话时自动发声阀（ASV）的固定。
纳入20名喉切除患者，他们均为常规使用粘合剂且有ASV使用经验的患者。在基线期以及使用可塑形粘合剂两周后，使用特定研究问卷进行数据收集。主要结局参数为免提讲话期间的粘合剂使用寿命、免提讲话的使用情况和持续时间以及患者偏好。其他结局参数为满意度、舒适度、贴合度和易用性。
在大多数参与者中，可塑形粘合剂能够实现足够的ASV固定以支持免提讲话。总体而言，与参与者的基线粘合剂相比，可塑形粘合剂显著提高了粘合剂使用寿命和免提讲话持续时间（p < 0.05），无论造口深度、皮肤刺激情况或基线期免提讲话的常规使用情况如何。偏好可塑形粘合剂的参与者（占参与者的55%）粘合剂使用寿命显著增加（中位数为24小时，范围为8 - 144小时），舒适度、贴合度和讲话便利性均有所改善。
可塑形粘合剂的使用寿命和功能方面，包括易用性和定制贴合度，是令人鼓舞的结果，能使更多喉切除患者更经常地使用免提讲话。
4 《喉镜》，133:2965 - 2970，2023年。
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