Osseointegrated Limb Implant Microbiome Population Adaptation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Determine if OI surgery causes changes in the microbiome community using phylogenies
研究概览
简要总结
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.
详细描述
Patients that are undergoing to have OI surgery will be asked if they would like to participate in the research study. All the data collected for the study is research related and will be collected on the case report forms ( CRFs) /source documents and will be entered into the Henry Jackson Foundation (HJF) REDCap.
Below is a breakdown of the research-related study procedures. All of these procedures will be done for research purposes, none of them are for the standard of care. The investigators will coincide study visit with clinical visits/ follow ups. The investigators will collect the following information from the patients/clinician:
Baseline/Pre-operative Surgery Stage I
Demographics (DOB, sex, height, weight, BMI, length of residual limb, amputated side, side indicated for surgery, date of amputation, reason for amputation, details of reason for amputation, issues with prior/current prosthesis) Medication: The investigators will collect detailed information about the medications (names, indication, dose, frequency, route. etc.) that the patients are currently taking (including over-the counter medications, vitamins, or herbal treatment).
Hygiene Questionnaire Biome sample (Osseointegrated and control site) Flora Data Collection Sample Questionnaire Flora Data Collection Sample Questionnaire-Control Holger Score System Questionnaire ( It is a score that the investigators is given after they evaluate the participant's skin condition).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult male or female that will undergo an OI procedure between the ages of 18-
- •Defense Enrollment Eligibility Reporting System (DEERs) eligible
排除标准
- •Inability to provide self-consent
结局指标
主要结局
Determine if OI surgery causes changes in the microbiome community using phylogenies
时间窗: month 36
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.
Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods
时间窗: months 36-48
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.
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.
时间窗: months 36-48
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
次要结局
- Floral profiles(months 40)
- Floral colonization(months 42)
- Clinical guidelines(month 48)
- Surgical site questionnaire(month 44)
- Post-OI hygiene guidelines(month 46)
- Soft tissue stability guidelines(month 46)
- Holger score validation(Time Frame: month 48)