At a glance
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A Randomized Controlled Trial to Investigate the Infectious Outcomes of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of Needle Tip During Transrectal Ultrasound Guided Prostate Biopsy
In Brief
A clinical study evaluating Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy for Prostate Cancer and 3 related conditions. Completed, enrolled 1,257 participants across 1 site.
Detailed Summary
The main purpose of this study is to compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy. The secondary objective is to evaluate predictive factors of infectious complications after prostate biopsy. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different groups: group A - rectal cleansing and disinfection of the needle tip vs group B - controls.
Study Details
Timeline
Interventions
The examiner will use a gauze soaked and saturated with iodopovidone and perform a mechanical friction motion on the anterior wall of the rectum, at least 5 times from one margin to another of the prostate laterally-laterally. A period of two (2) minutes shall be waited from the prophylactic cleaning of the rectum to the beginning of the biopsy. The examiner will use a technique of disinfecting the 10% formaldehyde biopsy needle without manual contact by soaking the distal 3 cm of the needle directly into a vial containing the bactericidal solution between obtaining the different fragments. An individual bottle will be used for each patient