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Name: Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study
Creator: University of Oklahoma
Published: 2026-03-27
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07494773 for Burns, Wound Infection is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection Phase 1, Phase 2 50 Randomized

Not yet recruiting

Clinical Trial NCT07494773 is designed to study Treatment for Burns, Wound Infection. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on June 1, 2026 until the study accrues 50 participants. Led by University of Oklahoma, this study is expected to complete by May 31, 2028. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.

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 ...Show More

Detailed Description

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...Show More

Official Title

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

Conditions

BurnsWound Infection

Publications

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.

Other Study IDs

HSC19626

NCT ID Number

NCT07494773

Start Date (Actual)

2026-06-01

Last Update Posted

2026-03-27

Completion Date (Estimated)

2028-05-31

Enrollment (Estimated)

Study Type

Interventional

PHASE

Phase 1
Phase 2

Status

Not yet recruiting

Keywords

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

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm

Intervention/Treatment

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.

Active ComparatorLight 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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

University of Rochester

Study Central Contact

Contact: Nicole A. Wilson, PhD, MD, 405-271-5922, [email protected]

1 Study Locations in 1 Countries

United States

Oklahoma

OU Health - Burn Unit, Oklahoma City, Oklahoma, 73104, United States

Nicole A. Wilson, PhD, MD, Contact, 405-271-5922, [email protected]

Nicole A. Wilson, PhD, MD, Principal Investigator

Arthur Grimes, MD, Sub-Investigator

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection Phase 1, Phase 2 50 Randomized

Inclusion Criteria

Exclusion Criteria