Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
ConditionAbscess
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Pregnancy
Lactation
Allergy to contrast media, narcotics, sedatives, atropine or eggs
Necrotic tissue that requires surgical debridement
Trial design
Treatments tested in this trial
- Methylene Blue
- Lipid Emulsion
- Insertion of optical fiber
- Laser Illumination (pre-defined dose)
- Optical Spectroscopy Measurement
- Laser Illumination (patient-specific dose)
- Standard of care abscess drainage
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov