N/A
N=10
Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)
Transfemoral Amputation
Bottom Line
View on ClinicalTrials.gov: NCT02564432 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Bacterial Community Types as Determined by Percentage RNA Sequence Reads — 3.4; 4.6; 4.7; 8.7 Percentage RNA sequence reads — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Community Types as Determined by Percentage RNA Sequence Reads |
3.4; 4.6; 4.7; 8.7; 2.2; 24.0 | <0.05 sig |
| SECONDARY Time to Equilibrium of the Bacterial Community Types Over the Duration of the Study |
2.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02564432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.