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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Methylene Blue

    Drug

    Administration of 0.1 mg/mL methylene blue to the abscess cavity, followed by a 10 minute incubation interval. After this incubation interval, the methylene blue solution will be aspirated from the cavity and flushed twice with sterile saline.

  • Lipid Emulsion

    Drug

    The abscess cavity will be filled with sterile 0.1% lipid emulsion solution to gently distend the cavity and, through efficient light scattering, to homogenize the light dose to the walls of the cavity. After laser illumination, the Intralipid will be aspirated from the cavity.

  • Insertion of optical fiber

    Device

    A sterile, FDA-approved optical fiber will be advanced to the approximate center of the abscess cavity via the drainage catheter under image guidance. Following laser illumination, the fiber will be withdrawn.

  • Laser Illumination (pre-defined dose)

    Device

    Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set such that the fluence rate at the abscess wall due to ballistic photons is 20 mW/cm2.

  • Optical Spectroscopy Measurement

    Device

    The same sterile optical fiber used for treatment will be advanced through the drainage catheter/needle in order to make gentle contact with the wall of the cavity. Low-intensity, polarized white light will be delivered by a tungsten halogen lamp by the fiber, and captured by the same fiber. Light that has been de-polarized by interaction with tissue will be detected by a spectrometer and analyzed to extract tissue optical properties. Upon completion of these measurements, the fiber optic will be withdrawn, gently wiped with sterile gauze, and returned to the procedure cart.

  • Laser Illumination (patient-specific dose)

    Device

    Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The optical power will be set to deliver a fluence rate of 20 mW/cm2 in 95% of the abscess wall, based upon abscess morphology and optical spectroscopy results.

  • Standard of care abscess drainage

    Procedure/Surgery

    Following standard practice, a drainage catheter will be placed in the abscess cavity and used to aspirate purulent fluid.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: MB-PDT at pre-defined dose plus standard of care abscess drainageExperimental treatment 5 interventions
Group B: MB-PDT at patient-specific dose plus standard of care abscess drainageExperimental treatment 6 interventions
Group C: Standard of care abscess drainageOther 1 intervention

Trial outcomes

Primary outcomes

1

Time to removal of the drainage catheter

Drainage catheter output into the drainage bag will be noted daily by a member of the study team and the drainage catheter will be removed when output is reduced to \<5 mL/day, as is standard of care for this patient population. Time to drainage catheter removal (in days) will be recorded for all subjects.

Time frame
Day 1 post-intervention until removal of drainage catheter

Secondary outcomes

1

Mean Change in bacterial burden

The outcome is reduction in colony-forming units per mL (CFU/mL) of bacteria in aspirate samples collected before and after intervention, measured on a log10 scale.

Time frame
Pre and post intervention (approximately 24 hours)
2

Total volume of catheter drainage output

Daily output from the placed drainage catheter will be followed from the day of intervention to the either 14 days post-intervention or removal of the drainage catheter, whichever comes first. Daily drainage volume will be recorded, and cumulative drainage volume for the entire catheter placement will be reported.

Time frame
day 14
3

mean number of days from intervention to symptom resolution

Daily report of fever, chills, pain, heart rate, and blood pressure. The first day on which there is no report of fever, chill, or pain, and where heart rate and blood pressure are within normal ranges for the subject, will be recorded as the date of clinical symptom resolution. The mean number of days from intervention to symptom resolution will be recorded for each arm.

Time frame
day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Source ClinicalTrials.gov

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