Peri-implant dermatitis implant inflammation Peri-implant dermatitis
Conditions
Interventions
A baha abutment switch.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the molecular bacterial profile of the Baha abutment as expressed in IS-lengths and quantities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are the correlations between bacterial flora and the change in flora in relation to clinical peri-implant skin infections. | — |
Countries
Netherlands
Outcome results
None listed