Status:
COMPLETED
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
Lead Sponsor:
University of Rochester
Conditions:
Abscess
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Deep tissue abscesses remain a significant cause of morbidity, mortality, and hospital stay despite improved surgical techniques and increasing use of perioperative antibiotics. Mortality ranges from ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02240498
Start Date
September 1 2014
End Date
September 1 2023
Last Update
March 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester Medical Center
Rochester, New York, United States, 14642