Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

Dartmouth Health

Status: Begins enrollment this month

Conditions: Amputation; Osseointegration

Treatments: Device: Photodynamic therapy (PDT); Drug: 5-aminolevulinic acid (5-ALA)

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06777511

STUDY02003108

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Osseointegration patients

Description:

All patients \>18 years with osseointegrated prostheses.

Treatment:

Drug: 5-aminolevulinic acid (5-ALA)

Device: Photodynamic therapy (PDT)