Prostate Biopsy Antisepsis

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

Interventions

DRUG

Povidone-iodine

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.

Sponsors & Collaborators

• University of British Columbia

  lead OTHER

Principal Investigators

• Peter Black, MD, FRCSC · University of British Columbia

• S. Larry Goldenberg, MD, FRCSC · University of British Columbia

• Lindsay Machan, MD, FRCPC · University of British Columbia

• Martin E. Gleave, MD, FRCSC · University of British Columbia

• William Bowie, MD, FRCPC · University of British Columbia

• Alan I. So, MD, FRCSC · University of British Columbia

• Diane Roscoe, MD, FRCPC · University of British Columbia

• Martin McLoughlin, MD, FRCSC · University of British Columbia

• Kourosh Afshar, MD, FRCSC · University of British Columbia

• Allen Rowley, MD, FRCPC · University of British Columbia

• Alison Harris, MD, FRCPC · University of British Columbia

• Anne Buckley, MD, FRCPC · University of British Columbia

• Stephen Ho, MD, FRCPC · University of British Columbia

• Audrey Spielmann, MD, FRCPC · University of British Columbia

• Silvia Chang, MD, FRCPC · University of British Columbia

• Zeid AbuGhosh, MD, FEBU · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• Canada

Study Locations