Study of the skin microbiome in patients with osseointegration surgery
Official title: Osseointegrated Limb Implant Microbiome Population Adaptation Study
Run by Walter Reed National Military Medical Center · NCT06310239 · Data updated 2026-11-12
This study is trying to see how the bacteria on the skin of people who have had osseointegration surgery affects their healing process compared to those without surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2029 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT06310239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-75 who are scheduled to undergo osseointegration surgery.
✕Probably not a fit
Patients who are unable to provide self-consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect cutaneous microbiome samples from 50 individuals who have undergone osseointegration surgery at multiple time points. The researchers will also gather control samples to account for natural variations in species composition and to compare the microbiome of the residual limb with that of the intact limb. By sequencing the bacterial communities and applying ecological theories, the study will assess the diversity of species present and how these assemblages correlate with wound healing rates. Data will be collected in conjunction with clinical visits and entered into a secure database for analysis.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how the microbiome affects wound healing in patients with osseointegration, potentially leading to improved post-surgical outcomes.
How similar studies have gone: While the specific approach of this study is novel, similar studies have shown that understanding the microbiome can influence healing outcomes in surgical patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any adult male or female that will undergo an OI procedure between the ages of 18-75. * Defense Enrollment Eligibility Reporting System (DEERs) eligible Exclusion Criteria: * Inability to provide self-consent
Where it's running
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Orhopaedic Surgery Service, Walter Reed National Military Medical Center,
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Ean R Saberski, MD — Walter Reed National Military Medical Center
- Study coordinator: Ean R Saberski, MD
- Email: Ean.saberski.mil@health.mil
- Phone: 301-319-4226
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.