CompletedNot Applicable

Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy

Brazil1,257 participantsStarted 2017-05-31

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signature of the consent term; * Agreement with the study follow-up protocol; * Indication of biopsy due to increased PSA (\> 2.5), abnormal rectal touch or patients under active surveillance protocol Exclusion Criteria: * Existence of cognitive deficit that impedes the reading and comprehension of the EHIC; * Allergy to ciprofloxacin or iodine

What they're measuring

Infectious complications

Timeframe: 1 week

Trial details

NCT IDNCT03879486

SponsorHospital de Transplante Doutor Euryclides de Jesus Zerbini

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-24

View on ClinicalTrials.gov More Prostate Cancer trials