Trial · NCT02240498
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
NCT02240498, Phase 1, Completed, University of Rochester
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities. Trials, record NCT02240498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02240498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
- NCT number
- NCT02240498
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Abscess
- Interventions
Methylene Blue, 20% I.V. Fat Emulsion, Insertion of optical fiber, Laser illumination, 5 minutes, Laser illumination, 10 minutes, Laser illumination, 15 minutes, Laser illumination, 20 minutes, Laser illumination, 25 minutes, Laser illumination, 30 minutes, Optical spectroscopy measurement
- First posted
- 2014-09-15
- Last updated
- 2026-04-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of study-related serious adverse events | Up to 14 days post-procedure | |
| Primary | Number of patients with study-related unanticipated adverse events | Up to 14 days post-procedure | |
| Primary | Evidence of fat embolism | Within 4 hours of Intralipid administration | Presentation of symptoms, including tachycardia, tachypnea, respiratory failure, decline in hematocrit, thrombocytopenia, and alteration of mental status in patient, will be deemed an unsafe outcome |
| Primary | Methylene blue escape during procedure with evidence of adverse reaction | Within 4 hours of methylene blue administration | If greater than 3 mg/kg of methylene blue escapes from the abscess (i.e. is not recovered), subject will be placed under observation for 4 hours. During this time, methylene blue related adverse reactions will be assessed. Presence of any of these adverse reactions during the observation period will be considered a safety failure. |
| Primary | Disruption of the abscess wall and damage to surrounding tissue | Up to 14 days post-procedure | CT imaging post-procedure will be compared to pre-drainage CT imaging for evidence of disruption of the abscess wall and damage to surrounding tissue |
| Primary | Need for surgery to remove a broken optical fiber fragment | Within 1 hour of the study procedure | If an optical fiber breaks within the patient and surgery is required to retrieve the fragment, this will be deemed an unsafe outcome |
| Primary | Number of patients with technically successful procedure | Within one hour of the trial procedure | Technical success includes successful image-guided placement of drainage catheter into the abscess, administration of methylene blue and Intralipid, placement of the optical fiber, laser irradiation, and successful removal of the entire optical fiber |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02240498
GET https://conductscience.org/api/trials/v1/NCT02240498/registered