Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
Completed · Phase 1
Conditions studied: Abscess
In brief
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. Optical measurements will additionally be performed at the abscess wall to determine optical properties and methylene blue uptake.
Key facts
- Study ID
- NCT02240498
- Run by
- University of Rochester
- People needed
- 21
- Starts
- 2014-09-01
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
- 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
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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