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

Conditions

• Abscess

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Methylene Blue — DRUG
  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.
• Lipid Emulsion — DRUG
  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.
• Insertion of optical fiber — DEVICE
  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 Following laser illumination, the fiber will be withdrawn.
• Laser Illumination (pre-defined dose) — DEVICE
  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.
• Optical Spectroscopy Measurement — DEVICE
  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 Upon completion of these measurements, the fiber optic will be withdrawn, gently wiped with sterile gauze, and returned to the procedure cart.
• Laser Illumination (patient-specific dose) — DEVICE
  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.
• Standard of care abscess drainage — PROCEDURE
  Following standard practice, a drainage catheter will be placed in the abscess cavity and used to aspirate purulent fluid.

Study Details

The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in time to removal of the drainage catheter.

Key Dates

Start date

Jul 15, 2026

Status verified

Feb 2026

Primary completion

Jun 30, 2031

Completion

Jun 30, 2031

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MB-PDT at pre-defined dose plus standard of care abscess drainage
  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.
• Experimental: MB-PDT at patient-specific dose plus standard of care abscess drainage
  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.
• Other: Standard of care abscess drainage
  Each subject in this arm will receive standard of care abscess drainage

Primary Outcome Measure

Time to removal of the drainage catheter [ Time Frame: Day 1 post-intervention until removal of drainage catheter ]

Central Contacts

• Timothy M Baran, PhD
  585-276-3188
  [email protected]
• Ashwani K Sharma, MD
  585-276-5491
  [email protected]

Locations (2)

Find similar trials in Rochester, NY

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