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

Официальное название

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Methylene Blue
  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.
• Устройство Blue Light Illumination
  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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Change in Quantitative Bacterial Burden [Срок оценки: Baseline, post-intervention Day 1, and post-intervention Day 2]
• Intervention Feasibility [Срок оценки: Intervention Day 1 and Intervention Day 2]
• Participant-Reported Pain During Intervention [Срок оценки: Immediately before and immediately after each intervention session (two sessions)]
• Treatment-Related Adverse Events [Срок оценки: From first intervention through 7 days post-intervention]

Критерии участия

Inclusion

• Age ≥18
• Partial- or full-thickness burn with partial-thickness component
• Expected ≥7 days dressing changes
• Able to consent

Exclusion

• Pregnancy or lactation

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.

• Current use of SSRIs, SNRIs, MAO inhibitors, and other serotonergic agents
• Inability to tolerate wound exposure
• Inability to consent
• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• OU Health - Burn Unit — Oklahoma City

Публикации

• Dai T, Huang YY, Hamblin MR. Photodynamic therapy for localized infections--state of the art. Photodiagnosis Photodyn Ther. 2009 Sep-Dec;6(3-4):170-88. doi: 10.1016/j.pdpdt.2009.10.008. PMID 19932449
• Hamblin MR, Hasan T. Photodynamic therapy: a new antimicrobial approach to infectious disease? Photochem Photobiol Sci. 2004 May;3(5):436-50. doi: 10.1039/b311900a. Epub 2004 Feb 12. PMID 15122361
• Wainwright M. Photodynamic antimicrobial chemotherapy (PACT). J Antimicrob Chemother. 1998 Jul;42(1):13-28. doi: 10.1093/jac/42.1.13. PMID 9700525
• Bhutani VK; Committee on Fetus and Newborn; American Academy of Pediatrics. Phototherapy to prevent severe neonatal hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2011 Oct;128(4):e1046-52. doi: 10.1542/peds.2011-1494. Epub 2011 Sep 26. PMID 21949150

Идентификаторы

NCT: NCT07494773 · HSC19626P

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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