Photodynamic therapy is a safe and feasible adjunct to percutaneous drainage of deep tissue abscesses: Results of a first in humans Phase 1 clinical trial

Abstract

AbstractBackgroundStandard of care for abscess management includes image-guided percutaneous drainage and antibiotics. However, cure rates vary between patients and there is growing concern for antibiotic-resistant bacteria. Photodynamic therapy (PDT), which utilizes light-activated dyes to generate cytotoxic reactive species, could complement the standard of care by sterilizing the abscess at time of drainage.PurposeThe goal of this study was to perform a first in humans Phase 1 clinical study evaluating safety and feasibility of PDT with methylene blue (MB) at the time of percutaneous abscess drainage. This was accomplished through an open-label dose escalation study, with duration of light delivery escalated from 5-30 minutes.Materials and MethodsWe performed MB-PDT in 18 subjects undergoing percutaneous abscess drainage. Following standard of care drainage, 1 mg/mL MB was delivered for 10 minutes. MB was aspirated, and 1% lipid emulsion infused to homogenize light dose at the cavity wall. An optical fiber was advanced to the approximate center of the abscess for 665 nm laser illumination at 20 mW/cm2.ResultsMB-PDT at the time of abscess drainage was safe and feasible in all cases, with no evidence of fat embolism due to lipid emulsion or adverse reaction to MB observed. No study-related adverse or serious adverse events were encountered, and the procedure was well tolerated by all subjects. While the study was not designed or powered to determine efficacy, time to resolution of clinical symptoms was significantly decreased in subjects receiving higher fluences (p=0.028). Additionally, drainage catheter output post-procedure was decreased in subjects receiving higher fluences (ρ=-0.18), although this difference was not significant (p=0.43).ConclusionMB-PDT is a safe and feasible adjunct to image-guided percutaneous abscess drainage. Clinical measures indicate a dose-dependent response to PDT, motivating future Phase 2 studies evaluating the efficacy of MB-PDT in this patient population.