The Baha Microbiome Case Control Study - A Molecular Bacterial Profile Of The Baha - BMCCS1

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•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).

发起方

Medisch Universitair Ziekenhuis Maastricht