Recruiting

Microbiome Study

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06310239

Conditions

Amputation With Osseointegration

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Collection of biologic samples and data

Study Details

Brief summary:

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.

Conditions

Amputation With Osseointegration

Study ID

NCT06310239

Start date

Dec 1, 2023

Status verified date

Aug, 2025

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Study subjects

Individuals with a limb amputation who are undergoing an osseointegration surgery

Interventions

Collection of biologic samples and data

  • collection of skin flora samples via swabs
  • data collection regarding subject's medications See Detailed Description in Study Description section above for more details

Primary outcome measure

  • Determine if OI surgery causes changes in the microbiome community using phylogenies [ Time Frame: month 36 ]
  • Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods [ Time Frame: months 36-48 ]
  • 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. [ Time Frame: months 36-48 ]

Central Contacts and Locations

Locations

Orhopaedic Surgery Service, Walter Reed National Military Medical Center,

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Principal Investigator:

Ean R Saberski, MD

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2025-08-26.