Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this Phase 1 study are to evaluate the safety and feasibility of methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination and imaging and laboratory studies in order to identify adverse events that may be induced by MB-PDT. We hypothesize that MB-PDT will be a safe and feasible intervention for this patient population.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Adults 18 years or older

• If female, patient must have negative pregnancy test

• 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

• Abscess cavity diameters will be less than or equal to 8 cm. However, abscess can be complex or loculated

• 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

• Abscesses greater than 8 cm in diameter, multiple separate abscesses in different locations, and abscesses not amenable to safe percutaneous image-guided drainage.

• Patient is currently taking serotonergic psychiatric medication