drugset / Trial / NCT02240498

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

NCT02240498

Phase 1 Completed 21 enrolled University of Rochester
Non-randomizedParallel-groupOpen-labelTreatment

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. Optical measurements will additionally be performed at the abscess wall to determine optical properties and methylene blue uptake.

Timeline

Start
2014-09
Primary completion
2023-09
Completion
2023-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylene Blue Diagnostic / imaging agent 1 mg/ml Other
Background Intralipid Other / unclassified 1 % Other

Indications