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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 15, 2025

Primary Completion Date

November 15, 2030

Study Completion Date

November 15, 2030

Conditions
Abscess
Interventions
DRUG

Methylene Blue

Administration of 0.1 mg/mL methylene blue to the abscess cavity, followed by a 10 minute incubation interval. After this incubation interval, the methylene blue solution will be aspirated from the cavity and flushed twice with sterile saline.

DRUG

Lipid Emulsion

The abscess cavity will be filled with sterile 0.1% lipid emulsion solution to gently distend the cavity and, through efficient light scattering, to homogenize the light dose to the walls of the cavity. After laser illumination, the Intralipid will be aspirated from the cavity.

DEVICE

Insertion of optical fiber

A sterile, FDA-approved optical fiber will be advanced to the approximate center of the abscess cavity via the drainage catheter under image guidance. Following laser illumination, the fiber will be withdrawn.

DEVICE

Laser Illumination (pre-defined dose)

Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set such that the fluence rate at the abscess wall due to ballistic photons is 20 mW/cm2.

DEVICE

Optical Spectroscopy Measurement

The same sterile optical fiber used for treatment will be advanced through the drainage catheter/needle in order to make gentle contact with the wall of the cavity. Low-intensity, polarized white light will be delivered by a tungsten halogen lamp by the fiber, and captured by the same fiber. Light that has been de-polarized by interaction with tissue will be detected by a spectrometer and analyzed to extract tissue optical properties. Upon completion of these measurements, the fiber optic will be withdrawn, gently wiped with sterile gauze, and returned to the procedure cart.

DEVICE

Laser Illumination (patient-specific dose)

Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set to deliver a fluence rate of 20 mW/cm2 in 95% of the abscess wall, based upon abscess morphology and optical spectroscopy results.

PROCEDURE

Standard of care abscess drainage

Following standard practice, a drainage catheter will be placed in the abscess cavity and used to aspirate purulent fluid.

Trial Locations (2)

14620

Highland Hospital, Rochester

14642

University of Rochester Medical Center, Rochester

All Listed Sponsors
lead

University of Rochester

OTHER