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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07494773
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Burns
  • Wound Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylene Blue — DRUG
    Methylene 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 — DEVICE
    Burn 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Methylene Blue Photodynamic Therapy
    Participants in this arm will receive methylene blue-mediated photodynamic therapy during routine burn dressing changes. Methylene blue will be applied to the burn wound surface followed by illumination with blue light using a clinical light source. Treatments will be administered during two consecutive dressing changes in addition to standard burn care.
  • Active Comparator: Light Therapy Alone
    Participants in this arm will receive blue light illumination during routine burn dressing changes without application of methylene blue. Treatments will be administered during two consecutive dressing changes in addition to standard burn care.

Primary Outcome Measure

Wound Healing Trajectory Measured by Digital Planimetry [ Time Frame: Baseline, post-intervention Day 1, post-intervention Day 2, and approximately 7 days after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OU Health - Burn UnitOklahoma CityOklahoma73104
Nicole A. Wilson, PhD, MD
[email protected]
405-271-5922
Nicole A. Wilson, PhD, MD (PRINCIPAL_INVESTIGATOR)
Arthur Grimes, MD (SUB_INVESTIGATOR)

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By research site
OU Health - Burn Unit· Oklahoma City, OK

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