Total Laryngectomy Patients Who Use Voice ProsthesesNCT02507401
Mixed-species Biofilms and Silicone Device Longevity
An observational study of Total Laryngectomy Patients Who Use Voice Prostheses, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Laryngectomy Patients Who Use Voice Prostheses
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to 1 Jan 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Users of voice prostheses who are registered at the Speech and Voice Clinic, Aberdeen Royal Infirmary.
Who may be able to join
- Total larygectomy patients.
- Must be registered at Speech and Voice Clinic, Aberdeen Royal Infirmary
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen
Aberdeen, Aberdeenshire, AB25 2ZD
About this study
Official title: Mixed-species Biofilm Composition as a Predictor of Device Longevity in Patients Using Silicone Medical Devices
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total laryngectomy patients | Users of voice prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of microbial species colonising medical device by patient
Quantification of the number of microbial species colonising medical device by patient
Measured: 12 months
Secondary outcomes (1)
Evidence that oral carriage of a specific microbial species constitutes a risk factor for increased frequency of voice prosthesis malfunction
Association of specific organism carriage and frequency of device change.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startSep 2015
- Primary completion31 Dec 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Laryngectomy Patients Who Use Voice ProsthesesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Principal investigator, Alex Brand, University of Aberdeen
- Investigators
- Alexandra Brand, BSc PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507401
- Sponsor's protocol ID
- 02/035/15
- Status last verified
- May 2017
- First submitted
- 21 Jul 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No individual patient data are available to the study
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed-species Biofilm Composition as a Predictor of Device Longevity in Patients Using Silicone Medical Devices
- ClinicalTrials.gov ID
- NCT02507401
- Acronym / sponsor ID
- 02/035/15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total laryngectomy patients | – | –Users of voice prostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Users of voice prostheses who are registered at the Speech and Voice Clinic, Aberdeen Royal Infirmary.
Key inclusion criteria (2 listed)
- Total larygectomy patients.
- Must be registered at Speech and Voice Clinic, Aberdeen Royal Infirmary
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of microbial species colonising medical device by patient
Time frame: 12 months
Quantification of the number of microbial species colonising medical device by patient
1 secondary outcome
Evidence that oral carriage of a specific microbial species constitutes a risk factor for increased frequency of voice prosthesis malfunction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No. No individual patient data are available to the study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Brand, BSc PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Laryngectomy Patients Who Use Voice Prostheses, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of microbial species colonising medical device by patient (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.