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

• Status: Not yet recruiting
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: All

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 bacterial burden from pre- to post-intervention, quantified by culture of abscess aspirates.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Methylene Blue; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Abscess greater than 13 cm in diameter