Methylene Blue-Photodynamic Therapy for Burns
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for burn wounds at risk of infection. Methylene Blue-Photodynamic Therapy combines methylene blue, a dye, with blue light to kill bacteria in wounds. Participants will receive either this new treatment or just blue light during regular dressing changes to assess its effectiveness in reducing infections and improving healing. Individuals with partial- or full-thickness burns requiring dressing changes for at least a week may qualify. The trial will also evaluate the treatment's safety and comfort. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to benefit from this innovative approach.
Will I have to stop taking my current medications?
If you are currently taking SSRIs, SNRIs, monoamine oxidase inhibitors, or other serotonergic medications, you will need to stop taking them to participate in this trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that methylene blue-photodynamic therapy (MB-PDT) is generally easy for patients to handle. In past studies, patients who received this treatment experienced less wound fluid without any harmful local reactions, suggesting the therapy is safe for treating burns. Other research supports its safety, indicating that MB-PDT can reduce smell, fluid leakage, and wound size. Most patients tolerated the treatment well.
Although this trial is in its early stages, previous evidence suggests that methylene blue-photodynamic therapy could be a safe option for managing burn wounds.12345Why do researchers think this study treatment might be promising for burns?
Unlike the standard burn care treatments, which typically involve topical antibiotics and regular dressing changes, Methylene Blue-Photodynamic Therapy stands out with its unique approach. This therapy uses methylene blue, a dye that, when exposed to blue light, generates reactive oxygen species to target and kill harmful bacteria in burn wounds. This mechanism could potentially speed up healing and reduce infection risk. Researchers are excited about this treatment because it combines a straightforward application with a novel light-activated action, offering a promising alternative to conventional methods.
What evidence suggests that methylene blue-photodynamic therapy might be an effective treatment for burn wound bacterial contamination?
Research has shown that methylene blue-photodynamic therapy (MB-PDT), which participants in this trial may receive, can effectively reduce bacterial infections in burn wounds. Studies indicate that it speeds up healing by lowering inflammation markers like TNF-α and IL-6 and boosting growth factors that aid recovery. In trials, patients experienced a significant reduction in wound size and fewer infection-related symptoms, such as bad odor. MB-PDT has also successfully treated infections from difficult-to-treat bacteria. Overall, MB-PDT appears promising as a non-antibiotic treatment for burn wound infections.13456
Who Is on the Research Team?
Nicole A. Wilson, PhD, MD
Principal Investigator
University of Oklahoma Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults (18+) with partial- or full-thickness burns that include a partial-thickness area and will need dressing changes for at least a week. People can't join if they're pregnant, breastfeeding, unable to consent, taking certain antidepressants, or can't tolerate wound exposure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive methylene blue-photodynamic therapy or light therapy alone during two consecutive dressing changes
Follow-up
Participants are monitored for safety, tolerability, and wound healing after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methylene Blue-Photodynamic Therapy
Trial Overview
The study compares two treatments during burn dressing changes: one group gets methylene blue applied to the wound followed by blue light therapy (photodynamic therapy), while the other group receives only blue light. The goal is to see if adding methylene blue helps reduce bacteria in burn wounds.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
University of Rochester
Collaborator
Citations
Photodynamic therapy mediated by methylene blue-loaded ...
MB-PEG based hydrogel improves and accelerates wound closure in the context of laser compared to either single treatment.
Topical Methylene Blue-Photodynamic Therapy (MB-PDT) ...
The primary objective of this study is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light ...
Photodynamic therapy for treatment of burns
The results of the meta-analysis showed that PDT effectively reduces TNF-α and IL-6 levels in wounds, and increases bFGF and VEGF levels, PDT can also reduce ...
Treatment of chronic wounds with methylene blue ...
The results were satisfactory, with significant wound size reduction, and a decrease in aspects indicative of infection including odor, presence ...
Control of Burn Wound Infection by Methylene Blue ...
Results. Even in the aPDT group, rapid bacterial regrowth was observed on the wound surface after each day's treatment, but the geometric mean ...
Control of Burn Wound Infection by Methylene Blue ...
In this study, we examined the usefulness of methylene blue (MB)-mediated antimicrobial photodynamic therapy (aPDT) with illumination by a light ...
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