nctId: NCT06310239 id: WRNMMC-2023-0434 id: 67407 type: OTHER_GRANT domain: PRORP briefTitle: Microbiome Population Adaptation Study acronym: OLIMPAS overallStatus: RECRUITING date: 2023-12-01 date: 2027-11-30 date: 2029-11-30 date: 2024-03-15 date: 2024-03-15 name: Walter Reed National Military Medical Center class: FED briefSummary: 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 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Collection of biologic samples and data measure: Determine if OI surgery causes changes in the microbiome community using phylogenies measure: Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods measure: 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. measure: Floral profiles measure: Floral colonization measure: Clinical guidelines measure: Surgical site questionnaire measure: Post-OI hygiene guidelines measure: Soft tissue stability guidelines measure: Holger score validation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orhopaedic Surgery Service, Walter Reed National Military Medical Center, status: RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Angelica M Melendez-Munoz role: CONTACT phone: 202-549-3229 email: angelica.m.melendez-munoz.ctr@health.mil name: Toby L Perkins role: CONTACT phone: 240-308-0548 email: toby.l.perkins.ctr@health.mil name: Ean R Saberski, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98067 lon: -77.10026 hasResults: False