University of Aberdeen
Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom
NCT Number: NCT02507401
The purpose of this study is to determine whether the mix of microbial species isolated from biofilm-clogged voice prostheses is specific to each participant, whether the microbes are orally-derived and whether the presence of specific species is a predictor of the frequency with which patients discard devices due to malfunction. The microbes isolated from discarded devices will be used to test the antimicrobial properties of newly-developed medical silicones.
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Notify Me18 year and older
All sexes
Observational
Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom
This study has three primary objectives and one secondary objective:
Primary Objectives
Secondary Objective
STUDY DESIGN
Four hypotheses will be addressed by this study:
These hypotheses will be addressed by collection of discarded devices from participants who are users of voice prostheses and registered at the Speech and Voice Clinic, Aberdeen Royal Infirmary (up to 27 people). Participants will be requested to donate discarded devices, mouthwash samples and simple data on recent antimicrobial or antacid treatments, and the use of dentures. The microbes colonising prostheses and contained within mouthwash samples will be isolated and identified and the association between microbial species and patient data over time will be analysed. Microbes will be stored as clinical isolates and used to test biofilm establishment and maintenance on silicones with modified surfaces designed to reduce biofouling.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
Quantification of the number of microbial species colonising medical device by patient
Time frame: 12 months
Association of specific organism carriage and frequency of device change.
University of Aberdeen
Other
Mixed-species Biofilm Composition as a Predictor of Device Longevity in Patients Using Silicone Medical Devices
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