A Phase 2 Study to Assess Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
University of Rochester
Summary
The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in time to removal of the drainage catheter.
Description
Abscesses form as a result of the interaction between an acute microbial infection and the host immune system, and generally result in fever, nausea, and acute abdominal pain. If untreated, the mortality rate can be high. Abscesses are routinely managed by image-guided percutaneous drainage and delivery of systemic antibiotics. Despite this standard of care, abscesses remain a significant source of morbidity, mortality, and hospital stay. Further, response can vary widely between patients. Many abscesses also contain antibiotic resistant species. Photodynamic therapy (PDT), which relies upon…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults 18 years or older * 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 * 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…
Interventions
- DrugMethylene Blue
Administration of 0.1 mg/mL methylene blue to the abscess cavity, followed by a 10 minute incubation interval. After this incubation interval, the methylene blue solution will be aspirated from the cavity and flushed twice with sterile saline.
- DrugLipid Emulsion
The abscess cavity will be filled with sterile 0.1% lipid emulsion solution to gently distend the cavity and, through efficient light scattering, to homogenize the light dose to the walls of the cavity. After laser illumination, the Intralipid will be aspirated from the cavity.
- DeviceInsertion of optical fiber
A sterile, FDA-approved optical fiber will be advanced to the approximate center of the abscess cavity via the drainage catheter under image guidance. Following laser illumination, the fiber will be withdrawn.
- DeviceLaser Illumination (pre-defined dose)
Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set such that the fluence rate at the abscess wall due to ballistic photons is 20 mW/cm2.
- DeviceOptical Spectroscopy Measurement
Locations (2)
- Highland HospitalRochester, New York
- University of Rochester Medical CenterRochester, New York