Amputation, Osseointegration
Conditions
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.
Interventions
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.
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.
Sponsors
Dartmouth-Hitchcock Medical Center
Walter Reed Army Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Presence of hypergranulation | 2 weeks | Hypergranulation measured using OCT |
| Pain during light exposure | 2 weeks | Patient reported pain during light exposure |
| Discomfort, burning, itchiness, or redness | 2 weeks | Patient reported discomfort, burning, itchiness or redness |
Countries
United States
Contacts
CONTACTDevin Mullin
CONTACTIda Gitajn
Outcome results
None listed