Peri-implant DermatitisBMCCS1NCT02073877
The Baha Microbiome Case Control Study
An observational study of Peri-implant Dermatitis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound processor. The system provides a hearing solution for a subgroup of patients who cannot sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to 40%) of associated peri-implant dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Dermatitis
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2014to Feb 2016
- How long will I take part?
- 3 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: Patients with a Cochlear Baha system.
Who may be able to join
- The patient is at least 18 years old
- The patient has a Cochlear Baha.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study if there exists:
- Participation in the Cochlear CBAS5439 study.
- The new abutment is not compatible with the current and future hearing aid.
- Patients can be included until both arms (controls vs. cases) are filled up.
- A condition that may have an impact on the outcome of the investigation as judged by the investigator (e.g. severe wound healing impairments). If so the reason should be noted. In general, patients who potentially could have severe wound healing impairments based on their medical history are excluded. This would include:
- Unregulated Diabetes Mellitus (DM). This is based on an prolonged elevated HbA1c (for more than 3 months > 7%) or patients reporting to have difficulties regulating their glucose and/or the presence of infectious diseases related to DM.
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- Any systemic immunosuppressant usage (e.g. corticosteroids).
- The usage of topical or systemic antibiotics which could affect the skin (e.g. excludes systemic antibiotics for urinary tract infections).
- Skin diseases (e.g. cases of psoriasis, eczema or other skin diseases which have in the past or currently involved the skin on the head, have a tendency to arise on disrupted skin or are not well predictable in their location and recurrence).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
About this study
Official title: The Baha Microbiome Case Control Study A Molecular Bacterial Profile Of The Baha Part 1 of the Baha Microbiome Study
The Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound processor. The system provides a hearing solution for a subgroup of patients who cannot sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to 40%) of associated peri-implant dermatitis. This research project is part of an attempt to reduce the amount of peri-implant dermatitis. Besides an attempt of Holgers to identify the skin flora in relation to infection around the abutment using a standard culture which yielded limited and no clinically relevant results, little is known about the microbiome on the abutment or its interaction with the commensal skin flora. Moreover, conventional cultures are not very sensitive in identifying bacteria. In 2010, Budding et al. introduced IS-pro. Is-pro is a novel 16S-23S rDNA interspace (IS)- region-based profiling method. This technology was devised to enable high-throughput molecular fingerprinting of microbioma. Since IS-pro is quick and relatively inexpensive, these environments can also be monitored over time by repeating the test. This paves the way for researching the microbiome on the abutment and it could enable clinically objective follow up of treatments in vivo using the human as a host. This technique allows researchers to even discover unknown, previously unidentified bacteria. Additionally, Scanning Electron Microscopy will be used to assess the spatial distribution and composition of bacteria on the abutment. The first step, using these techniques, is to determine the bacteria which inhabit the abutment also in relation to the surrounding skin. Additionally, the relationship with skin-implant infections and the effect of treatments will be monitored. Depending on these primary scientific results, a subsequent study will be devised to study (experimental) treatments in a randomized, controlled fashion.
Objectives of the study:
- To identify the bacterial flora on the abutment in a phylum/species classification.
- To assess the relationships between the commensal skin flora and the flora on the abutment and to study if clinical signs of peri-implant skin infection and subsequent treatment are associated with a change in bacterial composition.
- To assess if there exists a relationship between skin hygiene and the transient skin flora.
- Conditions
- Peri-implant Dermatitis
- Keywords
- Peri-implant dermatitis
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 |
|---|---|---|
| Controls - Holgers 0 & 1 | Not described | |
| Cases - Holgers >1 (active peri-implant dermatitis) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The bacterial flora on the Baha abutment.
The the bacterial flora is expressed in several nucleotides lengths and can be matched to a genome sequence database to a specific phylum and species. The relative quantities are calculated from the relative fluorescence units. The amount and spatial distribution of biofilm on the abutment will be estimated and expressed in a percentage of the surface covered by biofilm. The spatial distribution will be described in a qualitative manner.
Measured: At the inclusion visit (day 0)
Secondary outcomes (2)
Relationship between the bacterial profile and clinical outcomes
The biofilm presence (percentage) and the bacterial profile in infectious and non infectious states (Holgers index) will be compared.
Measured: At the inclusion visit (day 0)
Correlation between the bacterial profile and commensal skin flora
The dissimilarity or diversity will be studied between the bacterial flora on the abutment and on the skin (commensal flora).
Measured: At the inclusion visit (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant DermatitisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear Bone Anchored Solutions
- Responsible party
- Sponsor
- Investigators
- Robert J Stokroos, MD, PhD, Principal investigator, School for Mental Health and Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073877
- Sponsor's protocol ID
- 13-1-058.3
- Acronym
- BMCCS1
- Status last verified
- Feb 2014
- First submitted
- 17 Feb 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Baha Microbiome Case Control Study A Molecular Bacterial Profile Of The Baha Part 1 of the Baha Microbiome Study
- ClinicalTrials.gov ID
- NCT02073877
- Acronym / sponsor ID
- BMCCS1 / 13-1-058.3
- Conditions
- Peri-implant Dermatitis
- Keywords
- Peri-implant dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Cochlear Bone Anchored Solutions
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 27 Feb 2014 (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 Bone-Anchored Hearing Aid (Baha) system consists of an implanted part and sound processor. The system provides a hearing solution for a subgroup of patients who cannot sufficiently profit from conventional hearing aids. Disadvantageous are its high rate (up to 40%) of associated peri-implant dermatitis. This research project is part of an attempt to reduce the amount of peri-implant dermatitis. Besides an attempt of Holgers to identify the skin flora in relation to infection around the abutment using a standard culture which yielded limited and no clinically relevant results, little is known about the microbiome on the abutment or its interaction with the commensal skin flora. Moreover, conventional cultures are not very sensitive in identifying bacteria. In 2010, Budding et al. introduced IS-pro. Is-pro is a novel 16S-23S rDNA interspace (IS)- region-based profiling method. This technology was devised to enable high-throughput molecular fingerprinting of microbioma. Since IS-pro is quick and relatively inexpensive, these environments can also be monitored over time by repeating the test. This paves the way for researching the microbiome on the abutment and it could enable clinically objective follow up of treatments in vivo using the human as a host. This technique allows researchers to even discover unknown, previously unidentified bacteria. Additionally, Scanning Electron Microscopy will be used to assess the spatial distribution and composition of bacteria on the abutment. The first step, using these techniques, is to determine the bacteria which inhabit the abutment also in relation to the surrounding skin. Additionally, the relationship with skin-implant infections and the effect of treatments will be monitored. Depending on these primary scientific results, a subsequent study will be devised to study (experimental) treatments in a randomized, controlled fashion.
Objectives of the study:
- To identify the bacterial flora on the abutment in a phylum/species classification.
- To assess the relationships between the commensal skin flora and the flora on the abutment and to study if clinical signs of peri-implant skin infection and subsequent treatment are associated with a change in bacterial composition.
- To assess if there exists a relationship between skin hygiene and the transient skin flora.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls - Holgers 0 & 1 | – | – |
| Cases - Holgers >1 (active peri-implant dermatitis) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Cochlear Baha system.
Key inclusion criteria (2 listed)
- The patient is at least 18 years old
- The patient has a Cochlear Baha.
Key exclusion criteria (9 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study if there exists:
- Participation in the Cochlear CBAS5439 study.
- The new abutment is not compatible with the current and future hearing aid.
- Patients can be included until both arms (controls vs. cases) are filled up.
- A condition that may have an impact on the outcome of the investigation as judged by the investigator (e.g. severe wound healing impairments). If so the reason should be noted. In general, patients who potentially could have severe wound healing impairments based on their medical history are excluded. This would include:
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
The bacterial flora on the Baha abutment.
Time frame: At the inclusion visit (day 0)
The the bacterial flora is expressed in several nucleotides lengths and can be matched to a genome sequence database to a specific phylum and species. The relative quantities are calculated from the relative fluorescence units. The amount and spatial distribution of biofilm on the abutment will be estimated and expressed in a percentage of the surface covered by biofilm. The spatial distribution will be described in a qualitative manner.
2 secondary outcomes
Relationship between the bacterial profile and clinical outcomes
Time frame: At the inclusion visit (day 0)
Correlation between the bacterial profile and commensal skin flora
Time frame: At the inclusion visit (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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.
Robert J Stokroos, MD, PhD principal investigator
School for Mental Health and Neuroscience
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 Peri-implant Dermatitis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 9 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: status not confirmed, as of the sponsor's last update on 23 Sep 2015. 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 Netherlands. 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?
Results are not available in the source record.
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?
The bacterial flora on the Baha abutment. (time frame: At the inclusion visit (day 0)). 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 23 Sep 2015; AzTrials last refreshed its copy on 3 Nov 2026.