Status:
NOT_YET_RECRUITING
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Lead Sponsor:
University of Rochester
Conditions:
Abscess
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed 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 mortal...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients with pancreatic abscesses
- Patients with known fistulous communication with their abscess
- Abscess greater than 13 cm in diameter
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06052956
Start Date
December 15 2025
End Date
November 15 2030
Last Update
August 11 2025
Active Locations (2)
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1
Highland Hospital
Rochester, New York, United States, 14620
2
University of Rochester Medical Center
Rochester, New York, United States, 14642