OU Health - Burn Unit
Oklahoma City, Oklahoma, 73104, United States
Location contact
Arthur Grimes, MD
SUB_INVESTIGATOR
Nicole A. Wilson, PhD, MD
CONTACT
Nicole A. Wilson, PhD, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07494773
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Early Phase 1
Oklahoma City, Oklahoma, 73104, United States
Arthur Grimes, MD
SUB_INVESTIGATOR
Nicole A. Wilson, PhD, MD
CONTACT
Nicole A. Wilson, PhD, MD
PRINCIPAL_INVESTIGATOR
Burn wound infections remain a major complication following thermal injury and contribute to delayed wound healing, graft failure, prolonged hospitalization, and increased healthcare utilization. Management of burn wound bacterial contamination relies heavily on topical and systemic antibiotics. However, the increasing prevalence of antimicrobial-resistant organisms has created a need for alternative antimicrobial strategies that do not rely on conventional antibiotics. Photodynamic therapy (PDT) is a non-antibiotic antimicrobial approach that combines a photosensitizing compound with visible light to generate reactive oxygen species that rapidly kill bacteria through oxidative damage.
Methylene blue is a well-characterized photosensitizer with known antimicrobial activity when activated by visible light. When exposed to appropriate wavelengths of light, methylene blue produces singlet oxygen and other reactive oxygen species that disrupt bacterial cell membranes and intracellular components. Photodynamic therapy has demonstrated broad antimicrobial activity in laboratory and preclinical studies, including activity against antibiotic-resistant organisms. The use of PDT for treatment of contaminated wounds offers the potential to reduce bacterial burden while minimizing the risk of antimicrobial resistance.
This study is a randomized clinical trial designed to evaluate the safety and preliminary antimicrobial efficacy of methylene blue-mediated photodynamic therapy in burn wounds. 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. Methylene blue will be applied to the burn wound surface prior to illumination with a blue light source.
The primary objective of this study is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary objectives include evaluation of treatment safety, tolerability, and effects on wound healing. Results from this study will inform the feasibility and design of future trials evaluating photodynamic therapy as a novel adjunctive treatment for burn wound infection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion
Exclusion
o Pregnancy status will be determined by review of the medical record and, when clinically indicated per institutional policy, standard-of-care pregnancy testing. No additional pregnancy testing will be performed solely for research purposes.
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.
Other names: Methylthioninium Chloride
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.
Other names: Bili-lamp; Blue Light Phototherapy
Time frame: Baseline, post-intervention Day 1, post-intervention Day 2, and approximately 7 days after intervention
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, and post-intervention Day 2
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: Intervention Day 1 and Intervention Day 2
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: Immediately before and immediately after each intervention session (two sessions)
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: From first intervention through 7 days post-intervention
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.
Contact information is provided by the study sponsor or research team.
University of Oklahoma
Other
Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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