Clinical Trial

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection

Not Yet Recruiting Early Phase 1
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Summary
Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria. This randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.
Protocol Amendment History 1 change
critical Phase changed: Phase 1/2 -> Early Phase 1 2026-05-20
Trial Details
NCT Number NCT07494773
Lead Sponsor University of Oklahoma
Collaborators: University of Rochester
Conditions Burns, Wound Infection
Enrollment 50 participants
Start Date 2026-06
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-19