Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had three arms (groups): one (experimental), one (experimental) and Standard of care abscess drainage (other).

Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, and laser illumination at an optical power defined by their abscess size.

Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, optical spectroscopy, and laser illumination. The optical power for laser illumination will be determined by their abscess morphology and the results of optical spectroscopy.

Each subject in this arm will receive standard of care abscess drainage.

The registry classes the interventions as device, drug and procedure.

More on the Plan

Abscesses form as a result of the interaction between an acute microbial infection and the host immune system, and generally result in fever, nausea, and acute abdominal pain.

If untreated, the mortality rate can be high.

Abscesses are routinely managed by image-guided percutaneous drainage and delivery of systemic antibiotics.

Further, response can vary widely between patients.

Who Took Part

Enrollment: 120 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: Adults 18 years or older. Approval by the primary care team to pursue PDT and discuss enrollment with the patient.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: allergy to contrast media, narcotics, sedatives, atropine or eggs; necrotic tissue that requires surgical debridement; severely compromised cardiopulmonary function or hemodynamic instability.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2026-07-15 with completion listed for 2031-06-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to removal of the drainage catheter (time frame: Day 1 post-intervention until removal of drainage catheter).

It also tracked 3 secondary outcomes, for example Mean Change in bacterial burden, Total volume of catheter drainage output and mean number of days from intervention to symptom resolution.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 120 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.