Observational Study of Photodynamic Therapy for Osseointegrated Prosthesis Infection Prevention
This observational study is looking at a new way to prevent infections around osseointegrated prostheses (a type of artificial limb that connects directly to the bone). It will involve 10 patients aged 18 or older who have an osseointegrated prosthesis and do not have an active infection or are pregnant. The study will test if using 5-aminolevulinic acid (5-ALA) cream along with a light device (photodynamic therapy or PDT) can help prevent infections. This treatment will be part of your regular care for the stoma (the opening where the prosthesis connects). The main goal is to see if this treatment is practical to use, and this will be checked after 2 weeks. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study involving 10 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would apply topical 5-ALA cream and use a light delivery device as part of your daily stoma management. The first treatment will be at the clinic, and all others will be done at home.
- Compensation
- Not stated in the trial record.
- Follow-up
- The feasibility of the treatment will be measured at 2 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- Feasibility2 weeks
Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week/2-week follow-up.