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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Abscess

In brief

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 facts

Study ID

NCT06052956

Run by

University of Rochester

People needed

120

Starts

2026-07-15

Expected to finish

2031-06-30

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Abscess greater than 13 cm in diameter

Where it is running

• Highland Hospital — Rochester, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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