Study of the skin microbiome in patients with osseointegration surgery
Osseointegrated Limb Implant Microbiome Population Adaptation Study
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06310239 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who are scheduled to undergo osseointegration surgery.
Not a fit: Patients who are unable to provide self-consent will not benefit from this study.
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 performed: While the specific approach of this study is novel, similar studies have shown that understanding the microbiome can influence healing outcomes in surgical patients.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.