Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities

What Was Tested

This registered phase 1 trial tested Methylene blue (non-peptide stack partner).

The objectives of this Phase 1 study are to evaluate the safety and feasibility of methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess drainage to treat deep tissue abscesses.

Safety will be evaluated by physical examination and imaging and laboratory studies in order to identify adverse events that may be induced by MB-PDT.

It had six arms (groups): MB-PDT, 5 min illumination (experimental), MB-PDT, 10 min illumination (experimental), MB-PDT, 15 min illumination (experimental), MB-PDT, 20 min illumination (experimental) and MB-PDT, 25 min illumination (experimental).

The registry classes the interventions as device and drug.

More on the Plan

In these complex samples, the researchers found no evidence of resistance to MB-PDT.

Ultimately, this would promote early recovery, shorten hospital stay, and lead to lower overall health care costs for patients undergoing image-guided percutaneous abscess drainage.

Focused imaging is performed, which confirms that the collection is amenable to drainage.

The site is prepared and draped in the usual sterile fashion.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults 18 years or older. If female, patient must have negative pregnancy test. Abscess cavity diameters will be less than or equal to 8 cm. However, abscess can be complex or loculated. Approval by the primary care team to pursue PDT and discuss enrollment with the patient.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: allergy to contrast media, narcotics, sedatives, atropine or eggs; necrotic tissue that requires surgical debridement; severely compromised cardiopulmonary function or hemodynamic instability.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-09 with completion listed for 2023-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of study-related serious adverse events (time frame: Up to 14 days post-procedure). Number of patients with study-related unanticipated adverse events (time frame: Up to 14 days post-procedure). Evidence of fat embolism (time frame: Within 4 hours of Intralipid administration).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Methylene blue (non-peptide stack partner) in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.