title: Influence of surface roughness on silicone rubber voice prostheses on in vitro biofilm formation and clinical lifetime in laryngectomised patients.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Eleven laryngectomised patients in follow-up who required frequent replacement of their voice prostheses.
  
  
  METHODS
  Tertiary University Medical Center.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.|Department of Otorhinolaryngology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
authors.forename: K J D A
authors.initials: KJDA
authors.lastname: Buijssen
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: J J H
authors.initials: JJH
authors.lastname: Oosterhof
authors.affiliation: Principality Medical Ltd., Newport, UK.
authors.forename: L
authors.initials: L
authors.lastname: Basil
authors.affiliation: Principality Medical Ltd., Newport, UK.
authors.forename: M
authors.initials: M
authors.lastname: Waters
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: M A
authors.initials: MA
authors.lastname: Duits
authors.affiliation: Department of Biomedical Engineering, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: H J
authors.initials: HJ
authors.lastname: Busscher
authors.affiliation: Department of Biomedical Engineering, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: H C
authors.initials: HC
authors.lastname: van der Mei
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: B F A M
authors.identifier: http://orcid.org/0000-0002-5016-2871
authors.initials: BFAM
authors.lastname: van der Laan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018441:Biofilms; D005931:Glottis; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000601:surgery; D007822:Laryngeal Neoplasms / Q000601:surgery; D007825:Laryngectomy; D007831:Larynx, Artificial; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012826:Silicone Elastomers; D013499:Surface Properties
chemical_list: D012826:Silicone Elastomers
keywords: biofilm; laryngectomy; silicone; surface modification; surface roughness