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Could a blue dye and laser zap abscess bacteria?

NCT ID NCT02240498

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested whether a dye called methylene blue, activated by a laser, can safely sterilize deep abscess cavities during standard drainage. Twenty-one adults with abscesses requiring drainage received the treatment. The main goal was to check for safety issues like tissue damage or dye leakage, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylene blue
What this could lead to
If it works, this could provide a new way to kill bacteria in deep abscesses during drainage, potentially reducing the need for repeated procedures or stronger antibiotics.
What could go wrong
This is a very early phase 1 safety study with only 21 participants. It is not designed to prove effectiveness, and there are risks like damage to surrounding tissue or adverse reactions to methylene blue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Sep 2014

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults 18 years or older * If female, patient must have negative pregnancy test * 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 * 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 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 * Abscesses greater than 8 cm in diameter, multiple separate abscesses in different locations, and abscesses not amenable to safe percutaneous image-guided drainage. * Patient is currently taking serotonergic psychiatric medication

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

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