Transfemoral Amputation Clinical Trial
— MMPOPOfficial title:
Microbiome and Innate Immunity With Percutaneous Osseointegrated Prostheses
NCT number | NCT02564432 |
Other study ID # | A1544-I |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2015 |
Est. completion date | September 30, 2018 |
Verified date | February 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 30, 2018 |
Est. primary completion date | April 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. Is at least 18 years of age or older. 3. Has previously used or is currently using a "socket suspension technology" prosthesis 4. 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. 5. Is willing, able, and committed to participation in baseline and follow-up evaluations for the entire duration of the study. 6. Can provide written informed consent to participate. Exclusion Criteria: 1. Is currently on active or reserve military duty 2. Has experienced systemic bacterial infection or localized infection at the stump site within the previous 6 months 3. Has had more than 1 limb amputated 4. Has a body mass index (BMI) 30 5. Has insulin dependent diabetes mellitus (IDDM) or has adult onset DM with a glycated hemoglobin (HbA1c) > 53 mmol/mol (7.0%) at screening 6. Has residual femur bone length of less than 25% of the length of the contralateral femur. 7. Has clinically diagnosed vascular compromise proximal to the surgical site 8. Is pregnant at the time of surgery or plans to become pregnant within the first year of follow-up 9. Has evidence of recent tobacco use (urine cotinine test > 300 ng/mL [1703 nmol/L]) and is not committed to a smoking-cessation program 10. Has renal insufficiency (defined as serum creatinine of 1.8 mg/dL) or is currently receiving renal dialysis 11. 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 12. Has muscular, neurologic or vascular deficiencies that may compromise the bone or soft tissue healing of the affected extremity 13. Has anemia characterized by a hemoglobin of 11 g/dL at the time of surgery 14. Is currently on oral anticoagulation (excluding low-dose aspirin for cardiac prophylaxis) |
Country | Name | City | State |
---|---|---|---|
United States | VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time to Equilibrium of the Bacterial Community Types Over the Duration of the Study | Times required to reach stable Bacterial Community Types (CT) after the Stage 2 surgery. Dirichlet multinomial mixture modeling was used to examine the heterogeneity and optimal number of the community compositions within each sample site. Often, skin samples clustered optimally to a single community type. Five community types (CT1-5) were identified: CT1 was defined by mixed communities of obligate anaerobes. CT2 was defined as those with median Shannon diversity index of ~4.5. CT3 was defined as the microbial community with the Shannon index of ~ 0.6 and dominated by Streptococcus. CT4 and CT5 were characterized by high relative abundances of Corynebacterium (median = 49%) and Staphylococcus (median = 34%), respectively. Patients, post-surgery, stabilized to one of CT1 - CT5 stomal microbiota. | 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. |
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