Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

Not yet recruiting

• Conditions: Amputation; Osseointegration
• Interventions: Drug: 5-aminolevulinic acid (5-ALA); Device: Photodynamic therapy (PDT)

• Registration Number: NCT06777511
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-16
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Start: 2025-08-01
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osseointegration patients	5-aminolevulinic acid (5-ALA)	All patients \>18 years with osseointegrated prostheses.
Osseointegration patients	Photodynamic therapy (PDT)	All patients \>18 years with osseointegrated prostheses.

Primary Outcome Measures

Name	Time	Method
Feasibility	2 weeks	Feasibility will be defined as 80% of patients successfully completing the administration protocol as well as 1 week/2-week follow-up.

Secondary Outcome Measures

Name	Time	Method
Discomfort, burning, itchiness, or redness	2 weeks	Patient reported discomfort, burning, itchiness or redness
Presence of hypergranulation	2 weeks	Hypergranulation measured using OCT
Pain during light exposure	2 weeks	Patient reported pain during light exposure
Treatment Evaluation Inventory-Short Form (TEI-SF)	2 weeks	The TEI-sf is a 9-item questionnaire used to measure intervention acceptability from the participants point of view. Scores range from 9 to 45, and scores above 27 are considered acceptable.
System Usability Scale (SUS)	2 weeks	The SUS is a reliable 10-item usability measure with scores that range from 0 to 100 (an above average score is 68 or higher.
Bioburden quantification (16S rRNA sequencing)	2 weeks	Bioburden will be quantified using quantitative PCR-based assays as well as addition of a "spikein" of a defined quantity of bacterial cells derived from halophilic organism Salnibacter ruber.
Bioburden quantification (Optical Coherence Tomography (OCT)	2 weeks	Biofilm will be imaged and quantified on the metal abutment
OCT "virtual biopsy"	2 weeks	Presence of inflammation, hypergranulation, and any resulting changes (e.g., the degree of epidermal regression, dermal attachment to the implant, and epithelial layer thickness) can be quantified through morphologic analysis of the OCT B-scans. Scars are characterized by excessive collagen deposition, increased blood vessel density, and parallel blood vessel organization compared with normal skin.
Scar thickness	2 weeks	Scar thickness measured using OCT
Blood vessel density	2 weeks	Blood vessel density measuring using OCT