Clinical trial NCT06777511: Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients
Official title: Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amputation
Osseointegration
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Medical Center
First posted: 2025-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \&gt;18 years with osseointegrated prostheses are eligible. Patients will be excluded if they have an ongoing infection, are pregnant or if it is anticipate that they will have issues with compliance or follow-up.

Brief summary: 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.


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

Primary outcomes:
measure: Feasibility
timeFrame: 2 weeks
Secondary outcomes:
measure: Treatment Evaluation Inventory-Short Form (TEI-SF)
timeFrame: 2 weeks
measure: System Usability Scale (SUS)
timeFrame: 2 weeks
measure: Bioburden quantification (16S rRNA sequencing)
timeFrame: 2 weeks
measure: Bioburden quantification (Optical Coherence Tomography (OCT)
timeFrame: 2 weeks
measure: OCT "virtual biopsy"
timeFrame: 2 weeks
measure: Scar thickness
timeFrame: 2 weeks
measure: Blood vessel density
timeFrame: 2 weeks
measure: Presence of hypergranulation
timeFrame: 2 weeks
measure: Pain during light exposure
timeFrame: 2 weeks
measure: Discomfort, burning, itchiness, or redness
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References: