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

NCT07494773 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: HSC19626P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burns; Wound Infection

Keywords

Photodynamic Therapy; Methylene Blue; Burn Wound Infection; Antimicrobial Photodynamic Therapy; Reactive Oxygen Species; Burn Wound Bacterial Burden

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Methylene Blue Photodynamic Therapy

EXPERIMENTAL

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.

Drug: Methylene Blue; Device: Blue Light Illumination

Light Therapy Alone

ACTIVE COMPARATOR

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.

Device: Blue Light Illumination

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.

Also known as: Methylthioninium Chloride

Methylene Blue Photodynamic Therapy

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.

Also known as: Bili-lamp; Blue Light Phototherapy

Light Therapy Alone; Methylene Blue Photodynamic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• University of Rochester: collaborator

Study Sites (1)

OU Health - Burn Unit

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• Wainwright M. Photodynamic antimicrobial chemotherapy (PACT). J Antimicrob Chemother. 1998 Jul;42(1):13-28. doi: 10.1093/jac/42.1.13.

  PMID: 9700525 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Burns; Wound Infection

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nicole A. Wilson, PhD, MD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole A. Wilson, PhD, MD

CONTACT

405-271-5922; nicole-wilson@ou.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two parallel groups. One group will receive methylene blue photodynamic therapy with blue light illumination during routine burn dressing changes, while the control group will receive blue light illumination alone. Treatments will be administered during two consecutive dressing changes while participants continue to receive standard burn care.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)