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Methylene Blue - ClinicalTrials.gov

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Last Updated: 23 April 2022

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A Phase 1 Study to Assess Safety and Feasibility of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities

Image-guided percutaneous drainage therapy has been shown to improve patient outcomes and dramatically reduce mortality in uncomplicated fluid collections from 5% to 10-15%. Photodynamic therapy, which causes antimicrobial activity through the production of reactive oxygen species, may be a helpful adjunct to current standard care of treating deep tissue absces by lowering the microbial burden following drainage. Images-guided percutaneous drainage of an abscess cavity showed the results of methylene blue photodynamic therapy against organisms in primary aspirate fluid obtained from 32 patients who underwent image-guided percutaneous drainage of an absces cavity. These preclinical results obtained with samples obtained from absces tissue samples from our patients' absces are a valid basis for investigating the technical reliability and safety of advancing optical fibers through catheters into an absces cavity and performing PDT at the time of drainage. Patients with deep tissue abscess will have a variety of potential health benefits as a result of this therapeutic approach. A tungsten halogen lamp with a single fiber within the probe will be released by a single fiber within the probe and detected by eight other fibers within the investigation. A fiber-coupled laser diode will produce a low-power laser light following this procedure in order to excite methylene blue fluorescence. This results in a full body dose of 3. 85 mg/kg for a typical patient weight of 70 kg in the rare case of the complete methylene blue dose escapes into systemic circulation. The cavity will then be filled with sterile 1% Intralipid solution to lightly distend the cavity and homogenize the light dose to the cavity's walls by effective light scattering. The diode laser system used will measure optical strength in the procedure room and be used to determine the desired fluence rate at the wall, with total laser power in the range of 1-2 W. The diode laser system used will be able to determine and document the output from the optical fiber before treating each patient. If one dose-limiting toxicity is triggered, the upcoming group of patients will have the same exposure duration as the previous group. The study doctor or his designate will visit hospitalized patients daily to monitor growth and AEs. If the patient remains hospitalized as a result of unrelated to study participation, the study doctor or his designate will continue daily visits until the drain is removed, whichever comes first. If the abscess has cleared at day 7, as demonstrated by catheter delivery of less than 20 cc daily and inadequate imaging of the absces cavity, the drainage catheter will be removed as per departmental protocols and procedures. The catheter will stay in place and be evaluated again on day 14 if the absces persists beyond 7 days after drainage, despite drainage. If the abscess persists on day 7 and if medically indicated, further tests will be performed. Imaging at the time of catheter removal is considered a standard of care by imaging. All subjects must have a research visit at the day 7 post procedure. A second visit would be required at day 14 if the catheter is left in at that time. Subject research participation will end after the visit if the catheter is removed on day 7 and there are no unresolved AEs on the site. CBC w/ diff and serum creatinine will be obtained prior to the procedure, at minimum. Blood cultures will be obtained as clinically indicated, and drainage cultures will be established at day 0. After being exposed to methylene blue, there is very little chance of systemic skin photosensitivity. No skin photosensitivity was reported in scientific trials of MB-PDT administered intratumorally, intravesically, and gargling. After the procedure, the samples will be monitored for signs of skin photosensitivity reaction. No special precautions will be taken to limit the exposure of subjects to light after the procedure due to the rapid conversion of MB to leucomethylene blue in systemic circulation and the lack of photosensitivity in previous studies. The 21 participants will be followed until all clinical findings regarding image-guided drainage and MB-PDT have been published, according to the study's corresponding study. Whenever possible, 14 days post procedure will be evaluated by imaging and laboratory research at scheduled visits 7 days post surgery and, if required, 14 days post procedure.

Source link: https://clinicaltrials.gov/ct2/show/NCT02240498


A Non-Randomized, Prospective, Open Label, Single-site Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue fluoroPhore

Methylene blue can be used to produce a fluorescent signal and highlight the ureters' in real time during surgical procedures. Methods - In this research, patients who are in danger of ureter problems during abdominal surgery will be included. Patients with intraoperative methylene blue injection in increasing doses are included. Urine samples will be collected to determine the change of methylene blue to leucomethylene blue. The investigators are hoping to establish the patient population of concern and determine the reasons for non recruitment, based on the investigators' findings. The ureteric identification and conversion of methylene blue to leucomethylene blue are two secondary results.

Source link: https://clinicaltrials.gov/ct2/show/NCT05111808

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions