Mixed-species biofilms and silicone device longevity v0.1
Research type
Research Study
Full title
Mixed-species biofilm composition as a predictor of device longevity in patients using silicone medical devices
IRAS ID
149236
Contact name
Alexandra Brand
Contact email
Sponsor organisation
University of Aberdeen/NHS Grampian
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
Modern medicine uses a range of medical devices made of soft silicones, such as nasal and gastric tubes, which invariably become clogged by microbial biofilms and so require replacement. Biofilms are a particular nuisance for throat-cancer patients who rely on a small silicone implant called a voice prosthesis to produce the sound of speech. The device contains a tiny valve which ceases to function properly when it becomes coated with growing microbes, leading to leakage and loss of voice function. Some patients have to replace their device every few weeks, while others experience fewer problems, but managing voice devices leads to anxiety and a poorer quality of life in any patient. This study will help us to understand which microbes are causing the most problems and why.
By collecting discarded voice prostheses and oral rinses from participants, we will identify the microbes at the root of the problem and find out where they come from. In the lab, we will reconstruct the biofilms and test whether some microbes are particularly important for biofilm formation. By collecting prosthesis samples from patients over time, we will also find out whether each microbial population is unique to each patient and whether they change over time,. We will then be able to relate the composition of microbial biofilms to the frequency of device-associated problems reported by patients. This information may help patients who experience more problems than others and, in the long term, we can develop new silicones that resist for longer the attachment of problem microbes.
The study will involve up to 27 participants and will be sponsored and funded by the University of Aberdeen. The study will be carried out at the University’s Institute of Medical Sciences in association with the Speech and Voice Clinic at Aberdeen Royal Infirmary, NHS Grampian.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/1300
Date of REC Opinion
20 Jul 2015
REC opinion
Favourable Opinion