Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)

NCT02564432 | Completed Results

• 1 other identifier: A1544-I
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the clinical implementation of a new percutaneous prosthetic attachment system by determining the resident microbial ecology of the implant exit site and to simultaneously study the systemic and local stomal immune responses. This study will follow 10 patients implanted with percutaneous osseointegrated prosthetics (POPs) for a period of one year. Two state-of-the-art, pre- and post-surgery bacterial monitoring technologies will be used; these procedures are intended to facilitate the early prediction, detection, and treatment of infection, as well as to provide follow-up data that can potentially be used to advantageously manipulate the stomal microbial environment in future clinical trials. Commensal skin bacteria colonize all stomas. Colonization does not necessarily result in infection. Over time, the presence of this skin penetrating foreign object (implant) will cause measurable changes in the bacterial population (microbiota) at and around the POP exit site. It is anticipated that the evolving microbiota, in concert with measurable changes in the local and systemic cytokine responses, will reveal patterns associated with mutualistic-commensal bacteria and/or pathogenic bacteria related to the stages of chronic wound healing. These patterns could be used to determine the presence of a stable uninfected stoma or the progression of a stomal infection. Hopefully, this information will allow timely intervention to prevent infection, i.e. by detecting early stages of infection or discerning common patterns of stable mutualistic-commensal bacterial strains, effective intervention protocols (antibiotics, probiotics or manipulation of the stomal and skin microbiota) may be developed to avoid patient morbidity and assure implant survival.

Conditions

Transfemoral Amputation

Keywords

amputee

Outcome Measures

Primary Outcomes (1)

• Bacterial Community Types as Determined by Percentage RNA Sequence Reads

  To compare, within each participant, the Bacterial Community Type dynamics over time, we used Loess regression to visualize local (temporal) trends in the data. Specifically, it takes the scatter-plot of values (relative abundances, diversity indices) and uses smoothing to identify local trends in the data. As percentage RNA sequence reads were the measure of central tendency, measure of dispersion of the data was not possible to calculate.

  On Day 3 after first surgery and day 3 prior to and days, 3, 14 and week 6 and months 3, 6, 9 and 12 after second surgery.

Secondary Outcomes (1)

• Time to Equilibrium of the Bacterial Community Types Over the Duration of the Study

  On Day 3 after first surgery and day 3 prior to and days, 3, 14 and week 6 and months 3, 6, 9 and 12 after second surgery.

Study Arms (1)

POP 10 patient cohort

This is an observational study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 transfemoral amputees selected from Veteran and active military populations

You may qualify if:

• Is a US military Veteran with transfemoral limb loss, that occurred at least 6 months prior to consent, and that the amputation is not a result of dysvascular disease.
• Is at least 18 years of age or older.
• Has previously used or is currently using a "socket suspension technology" prosthesis
• Has, in the opinion of the investigator, normal cognitive function and no physical limitations, addictive diseases, or underlying medical conditions including tobacco use (continued testing for tobacco use will be performed at screening) that may prevent the subject from being an appropriate study candidate.
• Is willing, able, and committed to participation in baseline and follow-up evaluations for the entire duration of the study.
• Can provide written informed consent to participate.

You may not qualify if:

• Is currently on active or reserve military duty
• Has experienced systemic bacterial infection or localized infection at the stump site within the previous 6 months
• Has had more than 1 limb amputated
• Has a body mass index (BMI) 30
• Has insulin dependent diabetes mellitus (IDDM) or has adult onset DM with a glycated hemoglobin (HbA1c) \> 53 mmol/mol (7.0%) at screening
• Has residual femur bone length of less than 25% of the length of the contralateral femur.
• Has clinically diagnosed vascular compromise proximal to the surgical site
• Is pregnant at the time of surgery or plans to become pregnant within the first year of follow-up
• Has evidence of recent tobacco use (urine cotinine test \> 300 ng/mL \[1703 nmol/L\]) and is not committed to a smoking-cessation program
• Has renal insufficiency (defined as serum creatinine of 1.8 mg/dL) or is currently receiving renal dialysis
• Is currently involved in or plans to be involved in high levels of physical activity (competitive sports, heavy physical labor, etc) during the first 12 months of the rehabilitation stage
• Has muscular, neurologic or vascular deficiencies that may compromise the bone or soft tissue healing of the affected extremity
• Has anemia characterized by a hemoglobin of 11 g/dL at the time of surgery
• Is currently on oral anticoagulation (excluding low-dose aspirin for cardiac prophylaxis)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stomal and skin swab samples for bacterial 16S ribosomal RNA and fungal 18S ribosomal RNA. Blood samples to detect messenger ribonucleic acid (mRNA) of genes regulating production of immune proteins. Serous drainage from the stoma to determine wound healing cytokine expression.

Limitations and Caveats

This is an observational study limited by the small number of participants

Results Point of Contact

• Title: James Peter Beck
• Organization: Department of Veterans Affairs

james.beck@hsc.utah.edu

801-231-6309

Study Officials

• James P Beck, MD

  VA Salt Lake City Health Care System, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: October 1, 2015
• Primary Completion: April 18, 2018
• Study Completion: September 30, 2018
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)