Microbiome Population Adaptation Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWalter Reed National Military Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any adult male or female that will undergo an OI procedure between the ages of 18-75.

Defense Enrollment Eligibility Reporting System (DEERs) eligible

Disqualifiers

Inability to provide self-consent

Trial population

Male and female military health care beneficiaries aged 18-75 years old have undergone an osseointegrated percutaneous prosthetic system.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Collection of biologic samples and data

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Study subjects1 intervention

Trial outcomes

Primary outcomes

1

Determine if OI surgery causes changes in the microbiome community using phylogenies

We will use phylogenies and phylogenetic comparative methods to quantify the changes in the cutaneous microbiome flora before and after OI surgery. This will be done by comparing phylogenies across time points to determine changes in species lineage composition.

Time frame
month 36
2

Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods

We will use phylogenetic comparative methods and community turnover rates, quantified via alpha and beta diversity measures, to determine if community perturbations impact wound healing.

Time frame
months 36-48
3

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.

We will clinically quantify soft tissue stability using a modified Holger Score, then, we will use a phylogenetic correlation to determine if soft tissue health drives microbiome homeostasis

Time frame
months 36-48

Secondary outcomes

1

Floral profiles

We will use phylogenies to build species assemblages profiles (which species are present) for each participant. Then, we will use phylogenetic methods to compare profiles within each patient through time.

Time frame
months 40
2

Floral colonization

We will use the microbial profiles and phylogenies to determine the colonization order of the microbiome after OI surgery by comparing which species are present at baseline and which species are present at the subsequent follow-ups.

Time frame
months 42
3

Clinical guidelines

We will design and write clinical practice guidelines to identify a skin penetration aperture infection and disseminate to the public so others can use the same guidelines

Time frame
month 48
4

Surgical site questionnaire

We will develop and disseminate a questionnaire for the cleaning and maintenance of the skin penetration aperture to correlate hygiene routines and probability of developing a superficial infection.

Time frame
month 44

Other outcomes

Sponsors and contacts

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