Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Wound Healing Trajectory Measured by Digital Planimetry
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the visible application of methylene blue during photodynamic therapy, blinding of participants and treating clinicians is not feasible. Outcome measures include quantitative bacterial cultures obtained from burn wounds.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial- or full-thickness burn with partial-thickness component
- •Expected ≥7 days dressing changes
- •Able to consent
- •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
排除标准
- •Pregnancy or lactation
- •Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, or other serotonergic medications
- •Inability to tolerate wound exposure required for intervention
- •Inability to provide informed consent
研究组 & 干预措施
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.
干预措施: Blue Light Illumination (Device)
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.
干预措施: Blue Light Illumination (Device)
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.
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Wound Healing Trajectory Measured by Digital Planimetry
时间窗: 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.
次要结局
- Change in Quantitative Bacterial Burden(Baseline, post-intervention Day 1, and post-intervention Day 2)
- Intervention Feasibility(Intervention Day 1 and Intervention Day 2)
- Participant-Reported Pain During Intervention(Immediately before and immediately after each intervention session (two sessions))
- Treatment-Related Adverse Events(From first intervention through 7 days post-intervention)