Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Partial- or full-thickness burn with partial-thickness component
Expected ≥7 days dressing changes
Able to consent
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Methylene Blue
DrugMethylene blue will be applied topically to the burn wound surface prior to illumination. When activated by visible blue light, methylene blue acts as a photosensitizer that generates reactive oxygen species capable of killing bacteria. Methylene blue-mediated photodynamic therapy will be administered during two consecutive burn dressing changes.
Blue Light Illumination
DeviceBurn wounds will be illuminated using a clinical blue light source during routine dressing changes. In the experimental arm, illumination will occur after topical application of methylene blue to activate photodynamic therapy. In the control arm, illumination will occur without methylene blue application.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Methylene Blue Photodynamic TherapyExperimental treatment 2 interventions
Group B: Light Therapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound Healing Trajectory Measured by Digital Planimetry
Burn wound healing will be quantified using standardized digital photography and planimetric image analysis to measure wound surface area over time. Images will be obtained using a calibrated imaging system with a measurement scale included in each image. Wound area measurements will be analyzed longitudinally to assess changes in wound size over the study period.
Time frame
Baseline, post-intervention Day 1, post-intervention Day 2, and approximately 7 days after interventionSecondary outcomes
1
Change in Quantitative Bacterial Burden
Quantitative bacterial burden will be measured using standardized surface wound swab cultures obtained during routine dressing changes. Bacterial load will be quantified using colony-forming unit (CFU) counts and analyzed as log₁₀ change from baseline to post-intervention measurements.
Time frame
Baseline, post-intervention Day 1, and post-intervention Day 22
Intervention Feasibility
Feasibility will be assessed by the proportion of participants who successfully complete both intervention sessions during routine dressing changes without protocol deviation or early termination.
Time frame
Intervention Day 1 and Intervention Day 23
Participant-Reported Pain During Intervention
Pain will be assessed using a participant-reported 0-10 numeric rating scale obtained immediately before and immediately after each intervention session to evaluate treatment tolerability.
Time frame
Immediately before and immediately after each intervention session (two sessions)4
Treatment-Related Adverse Events
Adverse events potentially related to methylene blue application or visible light exposure will be recorded and graded according to CTCAE v5.0 criteria, including local wound reactions, unexpected pain escalation, or signs of systemic toxicity.
Time frame
From first intervention through 7 days post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oklahoma
Lead sponsor
University of Rochester
Collaborator
Source ClinicalTrials.gov
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