The primary objective of the study is to identify the bacterial flora on the abutment in a phylum/species classification. The secondary objectives are to assess the relationships between the commensal skin flora and the flora on the abutment and to…
ID
Source
Brief title
Condition
- Other condition
- External ear disorders (excl congenital)
- Bacterial infectious disorders
Synonym
Health condition
Peri-implant dermatitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the molecular bacterial profile of the Baha
abutment as expressed in IS-lengths and quantities.
Secondary outcome
Secondary study parameters are the correlations between bacterial flora and
the change in flora in relation to clinical peri-implant skin infections.
Background 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%2,3) 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.
Study objective
The primary objective of the study is to identify the bacterial flora on the
abutment in a phylum/species classification. The secondary objectives are 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. The
tertiary objective is to assess if there exists a relationship between skin
hygiene and the transient skin flora.
Study design
The study will be performed in a single tertriary center. The investigation has
an observational, case-control design in which the abutment will be replaced
for further analysis. The inclusion period is 12 months.
Intervention
A baha abutment switch.
Study burden and risks
In general, the risk in participating in this research will be low. The burden
for patients will mainly consist of having a several swabs collected which will
only take a few minutes. The abutment switch can sometimes be uncomfortable or
in the worst case painful. The patient could hear the unscrewing process. In
theory there could be a slight increase in the risk on peri-implant dermatitis.
Also, if there exists a loss of Osseointegration ( a complication on its own),
the abutment change should be aborted to prevent the removal of the implant. In
case inflammation arises, this can be handled with antibiotic ointments.
Overall, there will be no direct benefit for the individual patient. But the
increase in knowledge can be of added value to the current and future Baha
patient group.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet the following criteria
1. The patient is at least 18 years old
2. The patient has a Cochlear Baha.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study if there exists:
1. Participation in the Cochlear CBAS5439 study.
2. The new abutment is not compatible with the current and future hearing aid.
3. Patients can be included until both arms (controls vs. cases) are filled up.
4. 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:
a. 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.
b. Any systemic immunosuppressant usage (e.g. corticosteroids).
c. The usage of topical or systemic antibiotics which could affect the skin (e.g. excludes systemic antibiotics for urinary tract infections).
d. 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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42957.068.13 |