Prostate Biopsy Antisepsis - Full Text View

Purpose

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.

Condition	Intervention
Infective Complications Post-transrectal Prostate Biopsy	Drug: Povidone-iodine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Antiseptic Preparation of the Rectum Prior to Transrectal Prostate Biopsy

Resource links provided by NLM:

MedlinePlus related topics: Fever Sepsis Urine and Urination

Drug Information available for: Iodine Iodide Povidone-iodine

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Positive urine culture: bacterial growth >100 million colony forming units per litre from mid-stream voided urine sample [ Time Frame: 48 hours after biopsy ] [ Designated as safety issue: No ]
Fever: oral temperature ≥38.0˚C [ Time Frame: within 48 hours of biopsy ] [ Designated as safety issue: No ]
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 [ Time Frame: within 1 week of biopsy ] [ Designated as safety issue: No ]

Enrollment:	865
Study Start Date:	October 2009
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 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 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. Other Name: Betadine solution
No Intervention: B The randomly selected group of subjects who will receive the standard of care biopsy without any added intervention.

Arms

Assigned Interventions

Experimental: A

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

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.

Other Name: Betadine solution

No Intervention: B

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999427

Locations

Canada, British Columbia
Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Radiology Department - UBC Hospital
Vancouver, British Columbia, Canada
Radiology Department - Vancouver General Hospital
Vancouver, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Peter Black, MD, FRCSC	University of British Columbia
Study Director:	S. Larry Goldenberg, MD, FRCSC	University of British Columbia
Study Director:	Lindsay Machan, MD, FRCPC	University of British Columbia
Study Chair:	Martin E. Gleave, MD, FRCSC	University of British Columbia
Study Chair:	William Bowie, MD, FRCPC	University of British Columbia
Study Director:	Alan I. So, MD, FRCSC	University of British Columbia
Study Director:	Diane Roscoe, MD, FRCPC	University of British Columbia
Study Chair:	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

More Information

No publications provided

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00999427 History of Changes
Other Study ID Numbers:	H09-00289
Study First Received:	October 15, 2009
Last Updated:	May 4, 2012
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Povidone-iodine
prostate cancer
biopsy
transrectal ultrasound
urinary tract infection

fever
sepsis
antisepsis
prevention
complications

Additional relevant MeSH terms:

Povidone
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013