Microbiome Study for Prosthetic Limb Adaptation
(OLIMPAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how skin bacteria affect healing after osseointegration (OI) surgery, a procedure for individuals with limb amputations. Researchers will compare skin bacteria from the surgery site to the opposite limb to determine if certain bacteria help or hinder wound healing. The study will also examine how factors like limb type and gender might influence these bacterial communities and healing rates. This trial is for individuals who have had a limb amputated and are scheduled for OI surgery. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could improve healing outcomes for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this microbiome study is safe for prosthetic limb adaptation?
Research has shown that the microbiome, the community of bacteria living in the body, can aid healing after surgeries like osseointegration. This procedure involves attaching a prosthetic limb directly to the bone. Studies have found that the bacteria on the skin around the prosthesis usually do not cause harm and might even help by keeping harmful bacteria away.
In one study, researchers observed patients for 24 months and found that the bacteria around the prosthetic site did not increase the risk of infection. This finding suggests that the treatment is generally safe and well-tolerated for individuals who have undergone this type of surgery. Overall, the evidence indicates a good safety profile for adjusting the microbiome in these cases.12345Why are researchers excited about this trial?
Researchers are excited about the osseointegration surgery for individuals with limb amputations because it offers a more direct connection between the bone and prosthetic limb, which can improve mobility and comfort over traditional socket-based prosthetics. Unlike conventional methods that often lead to discomfort and require frequent adjustments, osseointegration provides a stable attachment point that can reduce skin irritation and enhance the user's ability to control the prosthetic. By directly anchoring the prosthetic to the skeleton, this approach has the potential to significantly improve the quality of life for amputees by allowing for a more natural range of motion and better sensory feedback.
What evidence suggests that this study's approach could be effective for improving wound healing after osseointegration surgery?
Research has shown that the microbiome, the group of bacteria on the skin, plays a crucial role in healing wounds after osseointegration (OI) surgery. Studies have found that the variety and types of bacteria can influence the speed and quality of wound healing. A balanced mix of bacteria appears to lead to better healing and fewer infections. Specifically, one study found that patients with a healthy mix of beneficial bacteria experienced fewer infections and better recovery over 24 months. Another study highlighted that certain bacteria might collaborate to protect against harmful germs and aid the healing process. This trial aims to understand these patterns to develop better treatments for individuals recovering from limb surgeries.12346
Who Is on the Research Team?
Ean R Saberski, MD
Principal Investigator
Walter Reed National Military Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline/Pre-operative Surgery Stage I
Collection of demographics, medication details, hygiene questionnaire, and biome samples
Pre-operative Surgery Stage II
Collection of biome samples and clinical assessment
Immediate Post-operative Surgery Stage II
Collection of biome samples in the operation room
Post-Operative Follow-Ups
Follow-up visits at 3 weeks, 3 months, 6 months, 12 months, and 24 months for biome sample collection and clinical assessment
Follow-up
Participants are monitored for changes in microbiome and soft tissue health
What Are the Treatments Tested in This Trial?
Interventions
- Microbiome Population Adaptation Study
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Individuals with a limb amputation who are undergoing an osseointegration surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Walter Reed National Military Medical Center
Lead Sponsor
Citations
Analysis of the Stomal Microbiota of a Percutaneous ...
This study was undertaken to determine if the resident microbiota might show evidence of a commensal (mutualistic or proto-cooperative) ...
Analysis of the Stomal Microbiota of a Percutaneous ...
Percutaneous osseointegrated (OI) prostheses (POPs) are used to skeletally attach artificial limbs in amputees. While any permanent percutaneous interface ...
Twenty-four months of bacterial colonialization and ...
Twenty-four months of bacterial colonialization and infection rates in patients with transcutaneous osseointegrated prosthetic systems after ...
4.
researchgate.net
researchgate.net/publication/334539183_Analysis_of_the_Stomal_Microbiota_of_a_Percutaneous_Osseointegrated_Prosthesis_-_A_Longitudinal_Prospective_Cohort_Study(PDF) Analysis of the Stomal Microbiota of a Percutaneous ...
Transcutaneous osseointegrated prosthetic systems for replacement of an upper or lower limb might not be an option in patients who are unable, for any reason, ...
Twenty-four months of bacterial colonialization and ...
Twenty-four months of bacterial colonialization and infection rates in patients with transcutaneous osseointegrated prosthetic systems after ...
The Role of Gut Microbiota in Orthopedic Surgery
The purpose of this study was to evaluate the gut microbiota on critical aspects of orthopedic surgical outcomes.
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