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

NCT06052956 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00008702
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Abscess

Keywords

Abscess; Drainage; Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• Time to removal of the drainage catheter

  Drainage catheter output into the drainage bag will be noted daily by a member of the study team and the drainage catheter will be removed when output is reduced to \<5 mL/day, as is standard of care for this patient population. Time to drainage catheter removal (in days) will be recorded for all subjects.

  Day 1 post-intervention until removal of drainage catheter

Secondary Outcomes (3)

• Mean Change in bacterial burden

  Pre and post intervention (approximately 24 hours)

• Total volume of catheter drainage output

  day 14

• mean number of days from intervention to symptom resolution

  day 14

Study Arms (3)

MB-PDT at pre-defined dose plus standard of care abscess drainage

EXPERIMENTAL

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.

Drug: Methylene Blue; Drug: Lipid Emulsion; Device: Insertion of optical fiber; Device: Laser Illumination (pre-defined dose); Procedure: Standard of care abscess drainage

MB-PDT at patient-specific dose plus standard of care abscess drainage

EXPERIMENTAL

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.

Drug: Methylene Blue; Drug: Lipid Emulsion; Device: Insertion of optical fiber; Device: Optical Spectroscopy Measurement; Device: Laser Illumination (patient-specific dose); Procedure: Standard of care abscess drainage

Standard of care abscess drainage

OTHER

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

Procedure: Standard of care abscess drainage

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.

Also known as: Methylene Blue Injection, 1%

MB-PDT at patient-specific dose plus standard of care abscess drainage; MB-PDT at pre-defined dose plus standard of care abscess drainage

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.

Also known as: Intralipid 20%, Nutrilipid 20%

MB-PDT at patient-specific dose plus standard of care abscess drainage; MB-PDT at pre-defined dose plus standard of care abscess drainage

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.

Also known as: Boston Scientific Flexiva Pulse ID

MB-PDT at patient-specific dose plus standard of care abscess drainage; MB-PDT at pre-defined dose plus standard of care abscess drainage

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.

Also known as: Modulight ML7710 Laser System

MB-PDT at pre-defined dose plus standard of care abscess drainage

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.

MB-PDT at patient-specific dose plus standard of care abscess drainage

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.

Also known as: Modulight ML7710 Laser System

MB-PDT at patient-specific dose plus standard of care abscess drainage

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.

Also known as: Image-guided percutaneous drainage

MB-PDT at patient-specific dose plus standard of care abscess drainage; MB-PDT at pre-defined dose plus standard of care abscess drainage; Standard of care abscess drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older
• All patients with clinical symptoms (ex: fever, chills, pain, tachycardia, hypotension), laboratory (leukocytosis) and radiologic findings (thick walled, rim-enhancing collection with gas bubbles or air-fluid levels) compatible with an abscess that requires image- guided percutaneous drainage
• Approval by the primary care team to pursue PDT and discuss enrollment with the patient

You may not qualify if:

• Pregnancy
• Lactation
• Allergy to contrast media, narcotics, sedatives, atropine or eggs
• Necrotic tissue that requires surgical debridement
• Severely compromised cardiopulmonary function or hemodynamic instability
• Thrombocytopenia (\<50,000/mm3)
• Uncorrectable coagulopathy
• Poor kidney function (serum creatinine \>3mg/dl)
• Lack of a safe pathway to the abscess or fluid collection
• Unable or unwilling to understand or to provide informed consent
• Unable or unwilling to undergo study procedures
• Patient unable to cooperate with, or to be positioned for the procedure
• Unable to comply with necessary follow up
• Patients with pancreatic abscesses
• Patients with known fistulous communication with their abscess

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

Highland Hospital

Rochester, New York, 14620, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Abscess

Interventions

Methylene Blue; Fat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Timothy M Baran, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Ashwani K Sharma, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Laurie Christensen, BS

  University of Rochester

  STUDY DIRECTOR

Central Study Contacts

Timothy M Baran, PhD

CONTACT

585-276-3188; Timothy_Baran@URMC.Rochester.edu

Ashwani K Sharma, MD

CONTACT

585-276-5491; Ashwani_Sharma@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject and study doctor will not be masked to group assignment, as it would be difficult or impossible to do so and unethical to subject patients to sham procedures if they are not assigned to a PDT group. However, all follow-up and subsequent data collection will be performed by a member of the study team that is masked to group assignment. Group assignment will only be unmasked to the study biostatistician at the time of statistical analysis. The remainder of the study team will only be unmasked after final results are published. This will reduce the potential for bias in collection of follow-up data, and protect the integrity of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)