Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

Обзор

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.

Вмешательства

• Препарат 5-aminolevulinic acid (5-ALA)
  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.
• Устройство Photodynamic therapy (PDT)
  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.

Первичные конечные точки

• Feasibility [Срок оценки: 2 weeks]

Вторичные конечные точки (10)

• Treatment Evaluation Inventory-Short Form (TEI-SF) [Срок оценки: 2 weeks]
• System Usability Scale (SUS) [Срок оценки: 2 weeks]
• Bioburden quantification (16S rRNA sequencing) [Срок оценки: 2 weeks]
• Bioburden quantification (Optical Coherence Tomography (OCT) [Срок оценки: 2 weeks]
• OCT "virtual biopsy" [Срок оценки: 2 weeks]
• Scar thickness [Срок оценки: 2 weeks]
• Blood vessel density [Срок оценки: 2 weeks]
• Presence of hypergranulation [Срок оценки: 2 weeks]
• Pain during light exposure [Срок оценки: 2 weeks]
• Discomfort, burning, itchiness, or redness [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• All patients with osseointegrated prostheses 18 years of age or older

Критерии исключения

• Ongoing infection
• Pregnant
• Anticipated issues with compliance or follow-up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Walter Reed National Military Medical Center — Bethesda

Идентификаторы

NCT: NCT06777511 · STUDY02003108

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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