Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5-aminolevulinic acid (5-ALA), Photodynamic therapy (PDT).
- Who it may be relevant to
- Registry conditions: Amputation, Osseointegration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD. All eligible consenting patients will undergo daily stoma management per standard of care. Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes. Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes. Follow-up: Study participants will be followed at 1 week and 2 weeks.
Interventions
- Drug 5-aminolevulinic acid (5-ALA)
All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device as part of their standard stoma management. - Device Photodynamic therapy (PDT)
All patients who are recruited and enrolled into this study use topical 5- ALA, in combination with the light delivery device photodynamic therapy device as part of their standard stoma management.
Primary outcome measures
- Feasibility [Time frame: 2 weeks]
Secondary outcome measures (10)
- Treatment Evaluation Inventory-Short Form (TEI-SF) [Time frame: 2 weeks]
- System Usability Scale (SUS) [Time frame: 2 weeks]
- Bioburden quantification (16S rRNA sequencing) [Time frame: 2 weeks]
- Bioburden quantification (Optical Coherence Tomography (OCT) [Time frame: 2 weeks]
- OCT "virtual biopsy" [Time frame: 2 weeks]
- Scar thickness [Time frame: 2 weeks]
- Blood vessel density [Time frame: 2 weeks]
- Presence of hypergranulation [Time frame: 2 weeks]
- Pain during light exposure [Time frame: 2 weeks]
- Discomfort, burning, itchiness, or redness [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- All patients with osseointegrated prostheses 18 years of age or older
Exclusion criteria
- Ongoing infection
- Pregnant
- Anticipated issues with compliance or follow-up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Walter Reed National Military Medical Center — Bethesda
Identifiers
NCT: NCT06777511 · STUDY02003108