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

NCT03879486 | Completed

• 1 other identifier: BIOPSY1
• Study Type: interventional
• Target: 1,257
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Prostatic Neoplasms; Prostate Biopsy; Prostatitis

Outcome Measures

Primary Outcomes (1)

• Infectious complications

  compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy

  1 week

Secondary Outcomes (1)

• evaluate predictive factors of infectious complications after prostate biopsy.

  1 week

Study Arms (2)

PVPI intervention

EXPERIMENTAL

rectal cleansing and disinfection of the needle tip at transrectal ultrasound guided prostate biopsy

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

Control arm

NO INTERVENTION

controls at transrectal ultrasound guided prostate biopsy

Interventions

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

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

PVPI intervention

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Existence of cognitive deficit that impedes the reading and comprehension of the EHIC;
• Allergy to ciprofloxacin or iodine

Sponsors & Collaborators

• Hospital de Transplante Doutor Euryclides de Jesus Zerbini: lead

Study Sites (1)

Hospital de Transplantes Euryclides de Jesus Zerbini

São Paulo, 01401901, Brazil

Location

Related Publications (24)

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• Zani EL, Clark OA, Rodrigues Netto N Jr. Antibiotic prophylaxis for transrectal prostate biopsy. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD006576. doi: 10.1002/14651858.CD006576.pub2.

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• Liss MA, Chang A, Santos R, Nakama-Peeples A, Peterson EM, Osann K, Billimek J, Szabo RJ, Dash A. Prevalence and significance of fluoroquinolone resistant Escherichia coli in patients undergoing transrectal ultrasound guided prostate needle biopsy. J Urol. 2011 Apr;185(4):1283-8. doi: 10.1016/j.juro.2010.11.088. Epub 2011 Feb 22.

  PMID: 21334021 BACKGROUND

• Duplessis CA, Bavaro M, Simons MP, Marguet C, Santomauro M, Auge B, Collard DA, Fierer J, Lesperance J. Rectal cultures before transrectal ultrasound-guided prostate biopsy reduce post-prostatic biopsy infection rates. Urology. 2012 Mar;79(3):556-61. doi: 10.1016/j.urology.2011.09.057.

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• Steensels D, Slabbaert K, De Wever L, Vermeersch P, Van Poppel H, Verhaegen J. Fluoroquinolone-resistant E. coli in intestinal flora of patients undergoing transrectal ultrasound-guided prostate biopsy--should we reassess our practices for antibiotic prophylaxis? Clin Microbiol Infect. 2012 Jun;18(6):575-81. doi: 10.1111/j.1469-0691.2011.03638.x. Epub 2011 Sep 29.

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• Taylor AK, Zembower TR, Nadler RB, Scheetz MH, Cashy JP, Bowen D, Murphy AB, Dielubanza E, Schaeffer AJ. Targeted antimicrobial prophylaxis using rectal swab cultures in men undergoing transrectal ultrasound guided prostate biopsy is associated with reduced incidence of postoperative infectious complications and cost of care. J Urol. 2012 Apr;187(4):1275-9. doi: 10.1016/j.juro.2011.11.115. Epub 2012 Feb 16.

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• Singla N, Walker J, Woldu SL, Passoni NM, de la Fuente K, Roehrborn CG. Formalin disinfection of prostate biopsy needles may reduce post-biopsy infectious complications. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):216-220. doi: 10.1038/pcan.2016.70. Epub 2017 Jan 24.

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• Zembower TR, Maxwell KM, Nadler RB, Cashy J, Scheetz MH, Qi C, Schaeffer AJ. Evaluation of targeted antimicrobial prophylaxis for transrectal ultrasound guided prostate biopsy: a prospective cohort trial. BMC Infect Dis. 2017 Jun 7;17(1):401. doi: 10.1186/s12879-017-2470-1.

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• Naughton CK, Miller DC, Mager DE, Ornstein DK, Catalona WJ. A prospective randomized trial comparing 6 versus 12 prostate biopsy cores: impact on cancer detection. J Urol. 2000 Aug;164(2):388-92.

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MeSH Terms

Conditions

Prostatic Neoplasms; Prostatitis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective controlled study

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: March 18, 2019
• Study Start: May 31, 2017
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

BR (1)