The Baha Microbiome Case Control Study - A Molecular Bacterial Profile Of The Baha
- Conditions
- Peri-implant dermatitis1001573210004018implant inflammation
- Registration Number
- NL-OMON38635
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the molecular bacterial profile of the Baha<br /><br>abutment as expressed in IS-lengths and quantities.</p><br>
- Secondary Outcome Measures
Name Time Method <p> Secondary study parameters are the correlations between bacterial flora and<br /><br>the change in flora in relation to clinical peri-implant skin infections. </p><br>