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.
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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