Microbiome Study for Amputation with Osseointegration
This study is looking at how the community of tiny living things (microbiome) on your skin changes after osseointegration (OI) surgery, a procedure where a prosthetic limb is directly connected to your bone. Researchers will collect skin samples from 50 people who have had OI surgery at different times over 3 to 4 years. They want to see if the surgery causes changes in your skin microbiome and if these changes can help predict how well your wound heals. They will also assess the health of your soft tissue. You can join if you are between 18 and 75 years old and are planning to have OI surgery. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study involving 50 participants. Researchers will collect samples and data at eight timepoints.
- What's involved
- You would provide skin swab samples and information about your medications. These procedures will coincide with your regular clinical visits/follow-ups.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 48 months (4 years) after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Microbiome Population Adaptation Study
At a glance
Conditions
NCT06310239
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Orhopaedic Surgery Service, Walter Reed National Military Medical Center,
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ean R Saberski, MD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Determine if OI surgery causes changes in the microbiome community using phylogeniesmonth 36
We will use phylogenies and phylogenetic comparative methods to quantify the changes in the cutaneous microbiome flora before and after OI surgery. This will be done by comparing phylogenies across time points to determine changes in species lineage composition.
- Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methodsmonths 36-48
We will use phylogenetic comparative methods and community turnover rates, quantified via alpha and beta diversity measures, to determine if community perturbations impact wound healing.
- Quantify soft tissue health using a modified Holger Score (0 = healthy soft issue and 6 = unhealthy soft tissue) to phylogenetically correlate this with microbiome homeostasis.months 36-48
We will clinically quantify soft tissue stability using a modified Holger Score, then, we will use a phylogenetic correlation to determine if soft tissue health drives microbiome homeostasis