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El ensayo clínico NCT07494773 para Quemaduras, Infección de la herida está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection Fase I, Fase II 50 Aleatorizado

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Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07494773 está diseñado para estudiar el tratamiento de Quemaduras, Infección de la herida. Este es un estudio intervencionista de Fase I Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de junio de 2026 hasta completar 50 participantes. Dirigido por University of Oklahoma, se espera que finalice el 31 de mayo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
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 ...Mostrar más
Descripción detallada
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 st...Mostrar más
Título oficial

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

Condiciones médicas
QuemadurasInfección de la herida
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • HSC19626
Número del NCT
NCT07494773
Inicio del estudio (real)
2026-06-01
Última actualización
2026-03-27
Fecha de finalización (estimada)
2028-05-31
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Estado general
Aún no recluta
Palabras clave
Photodynamic Therapy
Methylene Blue
Burn Wound Infection
Antimicrobial Photodynamic Therapy
Reactive Oxygen Species
Burn Wound Bacterial Burden
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalMethylene 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.
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.
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.
Comparador activoLight 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.
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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.
Baseline, post-intervention Day 1, post-intervention Day 2, and approximately 7 days after intervention
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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.
Baseline, post-intervention Day 1, and post-intervention Day 2
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.
Intervention Day 1 and Intervention Day 2
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.
Immediately before and immediately after each intervention session (two sessions)
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.
From first intervention through 7 days post-intervention
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Age ≥18 years
  • Partial- or full-thickness burn with a partial-thickness component
  • Expected to require dressing changes for ≥7 days
  • Ability to provide informed consent

  • 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
University of Oklahoma logoUniversity of Oklahoma
University of Rochester logoUniversidad de Rochester195 estudios activos para explorar
Contactos centrales del estudio
Contacto: Nicole A. Wilson, PhD, MD, 405-271-5922, [email protected]
1 Centros del estudio en 1 países

Oklahoma

OU Health - Burn Unit, Oklahoma City, Oklahoma, 73104, United States
Nicole A. Wilson, PhD, MD, Contacto, 405-271-5922, [email protected]
Nicole A. Wilson, PhD, MD, Investigador principal
Arthur Grimes, MD, Subinvestigador