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.
Age range
18 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of study-related serious adverse events
Timeframe: Up to 14 days post-procedure
Number of patients with study-related unanticipated adverse events
Timeframe: Up to 14 days post-procedure
Evidence of fat embolism
Timeframe: Within 4 hours of Intralipid administration
Methylene blue escape during procedure with evidence of adverse reaction
Timeframe: Within 4 hours of methylene blue administration
Disruption of the abscess wall and damage to surrounding tissue
Timeframe: Up to 14 days post-procedure
Need for surgery to remove a broken optical fiber fragment
Timeframe: Within 1 hour of the study procedure
Number of patients with technically successful procedure
Timeframe: Within one hour of the trial procedure