NCT00999427|CompletedDMC
Prostate Biopsy Antisepsis
Antiseptic Preparation of the Rectum Prior to Transrectal Prostate Biopsy
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Antiseptic Preparation of the Rectum Prior to Transrectal Prostate Biopsy
Sponsor study identifier
interventional
865
1 country
3
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 15, 2009
Actual (reported)October 21, 2009
Actual (reported)April 2011
Actual (reported)April 2011
Actual (reported)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
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.
The randomly selected group of subjects who will receive the standard of care biopsy without any added intervention.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Radiology Department - UBC Hospital
Vancouver, British Columbia, Canada
Radiology Department - Vancouver General Hospital
Vancouver, British Columbia, Canada
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
865 participants (actual enrollment reported by the registry).
First Submitted
October 15, 2009
First Posted
October 21, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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
Primary Completion
April 2011
Actual (reported)Study Completion
April 2011
Actual (reported)Last Updated
May 7, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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