RECRUITING

Microbiome Population Adaptation Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Osseointegrated Limb Implant Microbiome Population Adaptation Study

Quick Facts

Study Start:2023-12-01
Study Completion:2029-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06310239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any adult male or female that will undergo an OI procedure between the ages of 18-75.
  2. * Defense Enrollment Eligibility Reporting System (DEERs) eligible
  1. * Inability to provide self-consent

Contacts and Locations

Study Contact

Ean R Saberski, MD
CONTACT
301-319-4226
Ean.saberski.mil@health.mil
Angelica M Melendez-Munoz
CONTACT
202-549-3229
angelica.m.melendez-munoz.ctr@health.mil

Principal Investigator

Ean R Saberski, MD
PRINCIPAL_INVESTIGATOR
Walter Reed National Military Medical Center

Study Locations (Sites)

Orhopaedic Surgery Service, Walter Reed National Military Medical Center,
Bethesda, Maryland, 20889
United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

  • Ean R Saberski, MD, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2029-11-30

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2029-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Amputation With Osseointegration