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

What Was Tested

In this early phase 1 trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

It had two arms (groups): Methylene Blue Photodynamic Therapy (experimental) and Light Therapy Alone (active comparator).

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.

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.

The registry classes the interventions as device and drug.

More on the Plan

Management of burn wound bacterial contamination relies heavily on topical and systemic 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.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Partial- or full-thickness burn with partial-thickness component. Expected ≥7 days dressing changes. Able to consent. Pregnancy or lactation. Current use of SSRIs, SNRIs, MAO inhibitors, and other serotonergic agents.

The full record lists 9 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2026-06 with completion listed for 2028-05-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Wound Healing Trajectory Measured by Digital Planimetry (time frame: Baseline, post-intervention Day 1, post-intervention Day 2, and approximately 7 days after intervention).

It also tracked 4 secondary outcomes, for example Change in Quantitative Bacterial Burden, Intervention Feasibility, Participant-Reported Pain During Intervention and Treatment-Related Adverse Events.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 50 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.