Abscess Clinical Trial
Official title:
A Phase 1 Study to Assess Safety and Feasibility of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
Verified date | March 2024 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. We hypothesize that MB-PDT will be a safe and feasible intervention for this patient population. Optical measurements will additionally be performed at the abscess wall to determine optical properties and methylene blue uptake.
Status | Completed |
Enrollment | 21 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Haidaris CG, Foster TH, Waldman DL, Mathes EJ, McNamara J, Curran T. Effective photodynamic therapy against microbial populations in human deep tissue abscess aspirates. Lasers Surg Med. 2013 Oct;45(8):509-16. doi: 10.1002/lsm.22171. Epub 2013 Aug 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 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 | Within 4 hours of Intralipid administration | |
Primary | Methylene blue escape during procedure with evidence of adverse reaction | 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. | Within 4 hours of methylene blue administration | |
Primary | Disruption of the abscess wall and damage to surrounding tissue | 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 | Up to 14 days post-procedure | |
Primary | Need for surgery to remove a broken optical fiber fragment | If an optical fiber breaks within the patient and surgery is required to retrieve the fragment, this will be deemed an unsafe outcome | Within 1 hour of the study procedure | |
Primary | Number of patients with technically successful 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 | Within one hour of the trial procedure |
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