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

NCT03879486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1257

Last updated 2020-03-19

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy

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

Sponsors & Collaborators

  • Hospital de Transplante Doutor Euryclides de Jesus Zerbini

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-07-24
Completion
2019-07-24

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03879486 on ClinicalTrials.gov