- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507401
Mixed-species Biofilms and Silicone Device Longevity
Mixed-species Biofilm Composition as a Predictor of Device Longevity in Patients Using Silicone Medical Devices
Study Overview
Status
Detailed Description
This study has three primary objectives and one secondary objective:
Primary Objectives
- To understand variation in the composition of mixed-species biofilms on voice prostheses, both between patients and over time within patients. This will enable us to target resistance to specific microbes using chemistry-based approaches in the design of new medical silicones and develop realistic in vitro models using relevant clinical isolates with which to test them.
- To explore the association between the incidence of specific microbes in biofilms, patient factors (use of antimicrobials, antacids and dentures), and increased device-replacement frequency.
- To explore whether the colonising microbes originate from the participants's oral flora.
Secondary Objective
• To study the interactions that occur within the social group of microbes isolated from each voice prosthesis to learn a) whether these species are interdependent, b) whether they cooperate with each other in order to build biofilms and b) which species produce compounds that physically degrade medical polymers.
STUDY DESIGN
Four hypotheses will be addressed by this study:
- There is a correlation between the presence of certain microbes, or mixes of microbes, and the frequency of device replacement;
- The source of the problem microbes is the participants's oral flora;
- Participant-related factors such as continuous exposure of the microbes to antimicrobial or antacid treatments, or the use of dentures, may alter the composition of device biofilms.
- Identification of problem microbes may assist in the development of new medical silicones that are specifically designed to resist these species.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aberdeenshire
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Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
- University of Aberdeen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Total larygectomy patients.
- Must be registered at Speech and Voice Clinic, Aberdeen Royal Infirmary
Exclusion Criteria:
- Under 18 years of age
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Total laryngectomy patients
Users of voice prostheses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of microbial species colonising medical device by patient
Time Frame: 12 months
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Quantification of the number of microbial species colonising medical device by patient
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence that oral carriage of a specific microbial species constitutes a risk factor for increased frequency of voice prosthesis malfunction
Time Frame: 12 months
|
Association of specific organism carriage and frequency of device change.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexandra Brand, BSc PhD, University of Aberdeen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 02/035/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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