Health TrialsbyHealthPanel

Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

ConditionsAmputationOsseointegration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

All patients with osseointegrated prostheses 18 years of age or older

Disqualifiers

Ongoing infection

Pregnant

Anticipated issues with compliance or follow-up

Trial population

All patients \>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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 5-aminolevulinic acid (5-ALA)

    Drug

    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.

  • Photodynamic therapy (PDT)

    Device

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Osseointegration patients2 interventions

Trial outcomes

Primary outcomes

1

Feasibility

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

Time frame
2 weeks

Secondary outcomes

1

Treatment Evaluation Inventory-Short Form (TEI-SF)

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.

Time frame
2 weeks
2

System Usability Scale (SUS)

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.

Time frame
2 weeks
3

Bioburden quantification (16S rRNA sequencing)

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.

Time frame
2 weeks
4

Bioburden quantification (Optical Coherence Tomography (OCT)

Biofilm will be imaged and quantified on the metal abutment

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Walter Reed Army Medical Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: