Prostate Biopsy Antisepsis

NCT00999427 | Completed DMC

• 1 other identifier: H09-00289
• Study Type: interventional
• Target: 865
• Locations: 1 country
• Sites: 3

Brief Summary

During a prostate biopsy, a needle is guided through the rectum into the prostate. Although patients are given antibiotics before the biopsy, there is still a risk of bacteria getting from the rectum into the bladder, prostate and bloodstream during the biopsy. For most surgical procedures, the surgical field is cleaned with antiseptic solution, but this is not common practice for prostate biopsies. In this study patients undergoing prostate biopsy will be randomly assigned to either receive an antiseptic preparation of the rectum or no preparation prior to biopsy, and the rate of infection after the biopsy will be determined.

Conditions

Infective Complications Post-transrectal Prostate Biopsy

Keywords

Povidone-iodine; prostate cancer; biopsy; transrectal ultrasound; urinary tract infection; fever; sepsis; antisepsis; prevention; complications

Outcome Measures

Primary Outcomes (3)

• Positive urine culture: bacterial growth >100 million colony forming units per litre from mid-stream voided urine sample

  48 hours after biopsy

• Fever: oral temperature ≥38.0˚C

  within 48 hours of biopsy

• Sepsis: patient found to have positive urine culture and/or blood culture plus 2 or more of the following: i. temperature ≥38.0˚C or <36.0˚C ii. heart rate >90 beats/min. iii. respiratory rate >20 breaths/min iv. WBC count >12.0 or <4.0x109/L

  within 1 week of biopsy

Study Arms (2)

A

EXPERIMENTAL

The randomly selected group of subjects who will receive the intervention. The radiologist performing the transrectal prostate biopsy on these subjects will have a gauze soaked with Povidone-iodine over his/her index finger, and will insert this into the rectum. This gauze will be wiped back and forth across the prostate with the finger at least five times from one lateral margin to the other. This will be allowed to dry for 2 minutes before proceeding with the biopsy.

Drug: Povidone-iodine

B

NO INTERVENTION

The randomly selected group of subjects who will receive the standard of care biopsy without any added intervention.

Interventions

Povidone-iodine DRUG

Povidone-iodine 10% solution. A piece of 10x10 cm gauze soaked in Povidone-iodine 10% solution wrapped around the index finger of the examiner is inserted into the rectum of the subject in arm A. This gauze will be wiped back and forth across the prostate with the finger at least five times from one lateral margin of the prostate gland to the other. The examiner will allow at least 2 minutes to elapse between antisepsis and the insertion of the first needle into the prostate in order to allow the Povidone-iodine to dry.

Also known as: Betadine solution

A

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects scheduled at Vancouver General \& UBC Hospitals for a transrectal ultrasound guided prostate biopsy are eligible for this study. The indication for biopsy is made according to standard clinical reasoning and judgment, and is not affected by this study.
• All subjects must be willing and able to sign an informed consent and to take the ciprofloxacin prophylaxis before biopsy.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (3)

Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Radiology Department - UBC Hospital

Vancouver, British Columbia, Canada

Location

Radiology Department - Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Tract Infections; Fever; Sepsis

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Peter Black, MD, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• S. Larry Goldenberg, MD, FRCSC

  University of British Columbia

  STUDY DIRECTOR

• Lindsay Machan, MD, FRCPC

  University of British Columbia

  STUDY DIRECTOR

• Martin E. Gleave, MD, FRCSC

  University of British Columbia

  STUDY CHAIR

• William Bowie, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Alan I. So, MD, FRCSC

  University of British Columbia

  STUDY DIRECTOR

• Diane Roscoe, MD, FRCPC

  University of British Columbia

  STUDY DIRECTOR

• Martin McLoughlin, MD, FRCSC

  University of British Columbia

  STUDY CHAIR

• Kourosh Afshar, MD, FRCSC

  University of British Columbia

  STUDY CHAIR

• Allen Rowley, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Alison Harris, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Anne Buckley, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Stephen Ho, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Audrey Spielmann, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Silvia Chang, MD, FRCPC

  University of British Columbia

  STUDY CHAIR

• Zeid AbuGhosh, MD, FEBU

  University of British Columbia

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 21, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

CA (3)