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Microbiome Population Adaptation Study

Osseointegrated Limb Implant Microbiome Population Adaptation Study

Who can join

Ages 18 to 75 · All sexes

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

About the study

The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and "paint" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the military community as a whole.

What is being tested

• Collection of biologic samples and data (other)

Sponsor: Walter Reed National Military Medical Center · Participants: 50 · Started: Dec 1, 2023

Contact the study team

• Ean R Saberski, MD · Phone: 301-319-4226
• Angelica M Melendez-Munoz · Phone: 202-549-3229

Official record on ClinicalTrials.gov — NCT06310239

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.