Buijssen K J D A, Oosterhof J J H, Basil L, Waters M, Duits M A, Busscher H J, van der Mei H C, van der Laan B F A M
Department of Otorhinolaryngology-Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Biomedical Engineering, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Clin Otolaryngol. 2017 Dec;42(6):1235-1240. doi: 10.1111/coa.12856. Epub 2017 Mar 19.
Evaluation of the influence of a smooth surface moulding technique of silicone rubber indwelling voice prostheses on in vitro biofilm formation and analysis of the clinical in situ lifetime.
Biofilm formation on smooth and Groningen ultra low resistance (URL) prostheses was studied in an artificial throat model. The clinical lifetime of smooth voice prostheses was compared to the previous lifetime of URL by counting the number of replacements in a consecutive 6-month period in the same patient.
Eleven laryngectomised patients in follow-up who required frequent replacement of their voice prostheses.
Tertiary University Medical Center.
Use of a smoother mould and less viscous silicone rubber yielded a decrease in surface roughness from 46 to 8 nm and was accompanied by a 40% reduction in the prevalence of bacteria and yeast in in vitro formed biofilms. Clinically, the lifetime was significantly (P<.005) increased by a factor of 2.1.
This combined in vitro and clinical study suggests that the choice of material and in particular its surface finishing may be determining factors with respect to the clinical lifetime of silicone rubber implants and devices failing due to biofilm formation.
评估硅橡胶植入式语音假体的光滑表面成型技术对体外生物膜形成的影响，并分析其临床原位使用寿命。
在人工喉模型中研究光滑和格罗宁根超低阻力（URL）假体上生物膜的形成。通过计算同一患者连续6个月内更换的次数，将光滑语音假体的临床使用寿命与URL的先前使用寿命进行比较。
11名接受随访的喉切除患者，他们需要频繁更换语音假体。
三级大学医学中心。
使用更光滑的模具和粘性较小的硅橡胶可使表面粗糙度从46纳米降至8纳米，并使体外形成的生物膜中细菌和酵母菌的患病率降低40%。临床上，使用寿命显著（P<0.005）提高了2.1倍。
这项体外和临床相结合的研究表明，材料选择尤其是其表面处理可能是影响硅橡胶植入物和因生物膜形成而失效的装置临床使用寿命的决定性因素。
