Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
Abscess
About this trial
This is an interventional treatment trial for Abscess focused on measuring Abscess, Drainage
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Rochester Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
MB-PDT, 5 min illumination
MB-PDT, 10 min illumination
MB-PDT, 15 min illumination
MB-PDT, 20 min illumination
MB-PDT, 25 min illumination
MB-PDT, 30 min illumination
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, and laser illumination, 5 minutes.
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 10 minutes.
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 15 minutes.
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 20 minutes.
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 25 minutes.
Each subject in this group will receive methylene blue, 20% I.V. fat emulsion, insertion of optical fiber, optical spectroscopy measurement, and laser illumination, 30 minutes.