Photodynamic Therapy for Abscess

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAshwani K Sharma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Rochester

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 bacterial burden from pre- to post-intervention, quantified by culture of abscess aspirates.

Eligibility Criteria

Adults over 18 with symptoms, lab results, and scans indicating an abscess needing drainage can join. They must be approved by their care team for PDT treatment. Excluded are those with poor kidney function, pregnant or lactating individuals, low platelet counts, bleeding disorders, no safe access to the abscess, inability to consent or follow procedures, large abscesses (>13 cm), allergies to certain substances including contrast media and eggs.

Inclusion Criteria

I have symptoms and test results that suggest I have an abscess needing drainage.

My doctor agrees I can try photodynamic therapy and discuss joining the trial.

I am 18 years old or older.

Exclusion Criteria

You are allergic to certain substances like contrast media, narcotics, sedatives, atropine, or eggs.

Unable to comply with necessary follow up

I am unable to understand or agree to the study details.

+11 more

Participant Groups

The trial tests Methylene Blue Photodynamic Therapy (MB-PDT) during standard abscess drainage. It has three parts: one uses a fixed MB-PDT dose plus drainage; another tailors the dose based on optical measurements plus drainage; the third only does standard drainage. The main goal is seeing how well each method reduces bacteria in the abscess.

3Treatment groups

Experimental Treatment

Group I: Standard of care abscess drainageExperimental Treatment1 Intervention

Each subject in this arm will receive standard of care abscess drainage

Group II: MB-PDT at pre-defined dose plus standard of care abscess drainageExperimental Treatment5 Interventions

Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, and laser illumination at an optical power defined by their abscess size.

Group III: MB-PDT at patient-specific dose plus standard of care abscess drainageExperimental Treatment6 Interventions

Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, optical spectroscopy, and laser illumination. The optical power for laser illumination will be determined by their abscess morphology and the results of optical spectroscopy.