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NCT02564432 · ClinicalTrials.gov registry record
Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 10
- Enrollment target
NCT02564432: Completed study, sponsored by VA Office of Research and Development.
NCT02564432 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02564432 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the clinical implementation of a new percutaneous prosthetic attachment system by determining the resident microbial ecology of the implant exit site and to simultaneously study the systemic and local stomal immune responses. This study will follow 10 patients implanted with percutaneous osseointegrated prosthetics (POPs) for a period of one year. Two state-of-the-art, pre- and post-surgery bacterial monitoring technologies will be used; these procedures are intended to facilitate the early prediction, detection, and treatment of infection, as well as to provide follow-up data that can potentially be used to advantageously manipulate the stomal microbial environment in future clinical trials. Commensal skin bacteria colonize all stomas. Colonization does not necessarily result in infection. Over time, the presence of this skin penetrating foreign object (implant) will cause measurable changes in the bacterial population (microbiota) at and around the POP exit site. It is anticipated that the evolving microbiota, in concert with measurable changes in the local and systemic cytokine responses, will reveal patterns associated with mutualistic-commensal bacteria and/or pathogenic bacteria related to the stages of chronic wound healing. These patterns could be used to determine the presence of a stable uninfected stoma or the progression of a stomal infection. Hopefully, this information will allow timely intervention to prevent infection, i.e. by detecting early stages of infection or discerning common patterns of stable mutualistic-commensal bacterial strains, effective intervention protocols (antibiotics, probiotics or manipulation of the stomal and skin microbiota) may be developed to avoid patient morbidity and assure implant survival.
Primary Outcome
To compare, within each participant, the Bacterial Community Type dynamics over time, we used Loess regression to visualize local (temporal) trends in the data. Specifically, it takes the scatter-plot of values (relative abundances, diversity indices) and uses smoothing to identify local trends in the data. As percentage RNA sequence reads were the measure of central tendency, measure of dispersion of the data was not possible to calculate.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2018-09-30 |
What the finished NCT02564432 record still lists
NCT02564432 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02564432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02564432 about?
NCT02564432 is a clinical study titled "Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)". The purpose of this study is to investigate the clinical implementation of a new percutaneous prosthetic attachment system by determining the resident microbial ecology of the implant exit site and to simultaneously study the systemic and local stomal immune responses. This study will follow 10 pati...
What is the current status of trial NCT02564432?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2015-10-01. Estimated completion is 2018-09-30.
Who is sponsoring clinical trial NCT02564432?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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