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Search / Trial NCT06052956

Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses

Launched by UNIVERSITY OF ROCHESTER · Sep 18, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Abscess Drainage Photodynamic Therapy

ClinConnect Summary

This clinical trial is investigating a new treatment called methylene blue photodynamic therapy (MB-PDT) for patients with deep tissue abscesses, which are painful pockets of infection in the body. The study aims to see how effective MB-PDT is when used alongside standard treatments for draining these abscesses. There are three groups in the trial: one group will receive a set amount of MB-PDT, another group will receive a personalized dose based on pre-treatment tests, and the third group will only receive the standard drainage treatment. Researchers will measure how well these approaches reduce the number of bacteria in the abscesses.

To participate in this trial, individuals need to be at least 18 years old and have signs of an abscess that requires drainage, such as fever or high white blood cell counts. However, certain people may not be eligible, including those who are pregnant, have serious heart or lung issues, or have certain allergies. The trial is not yet recruiting participants, but if you or a loved one is interested, it’s essential to discuss this with a healthcare provider who can provide more information and determine if you qualify.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 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
  • Patients with pancreatic abscesses
  • Patients with known fistulous communication with their abscess
  • Abscess greater than 13 cm in diameter

About University Of Rochester

The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.

Locations

Rochester, New York, United States

Rochester, New York, United States

Patients applied

0 patients applied

Trial Officials

Timothy M Baran, PhD

Principal Investigator

University of Rochester

Ashwani K Sharma, MD

Principal Investigator

University of Rochester

Laurie Christensen, BS

Study Director

University of Rochester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported