drugset / Trial / NCT07494773

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

NCT07494773

Phase 0 Not yet recruiting 50 enrolled University of Oklahoma University of Rochester · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-06
Primary completion
2028-05-31
Completion
2028-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylene Blue Diagnostic / imaging agent Topical

Indications