An observational study in Peri-implant Dermatitis, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Maastricht University Medical Center · Observational
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:
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 232 observational studies indexed under Dermatitis.
Browse Dermatitis studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a Cochlear Baha system.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study if there exists:
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:
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.
Time frame: At the inclusion visit (day 0)
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.
Time frame: 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).
Time frame: At the inclusion visit (day 0)
The change in the bacterial flora over time
In some patients additional swabs will be acquired to prospectively monitor the composition and change in the bacterial flora in relation to the clinical follow up visits measured in the Holgers Index.
Time frame: Inclusion visit - 3 months
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center