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