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Effect of Chlorhexidine on Bacteriuria

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ClinicalTrials.gov Identifier: NCT02032394
Recruitment Status : Unknown
Verified January 2014 by Seyedreza Mazloum, Mashhad University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Seyedreza Mazloum, Mashhad University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 10, 2014
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
  • Bacteriuria day 1 [ Time Frame: day 1 after urinary catheterizatiion ]
    Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
  • Bacteriuria day 3 [ Time Frame: Day 3 after catheterization ]
    Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
  • Bacteriuria day 5 [ Time Frame: day 5 after catheterization ]
    Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
  • Bacteriuria day 7 [ Time Frame: Day 7 after catheterization ]
    Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
  • Bacteriuria day 9 [ Time Frame: Day 9 after cathetrization ]
    Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
  • Microorganism Type day 5 [ Time Frame: Days 5 after catheterization ]
    Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection.
  • Microorganism type day 10 [ Time Frame: Day 10 after catheterization ]
    Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Chlorhexidine on Bacteriuria
Official Title  ICMJE Comparison of the Effect of Applying Povidone-iodine and Chlorhexidine Solutions for Perinea Washing on Bacteriuria Rate and Type in Patients With Urinary Catheter in Intensive Care Unit
Brief Summary This study is conducted to determine and compare the effect of applying Povidone-iodine and Chlorhexidine solutions for perinea washing on bacteriuria rate and type in patients with urinary catheter in intensive care unit.
Detailed Description This is a double blind randomized study with control group. The population is patients in intensive care unit of Shahid Beheshti hospital of Babol city. Main include criteria are 18-55 years old, need to having urine catheter for 10 days at least and no urinary infection in catheterization time. Main exclude criteria are appearing genital wound, allergic or dermatitis disorders. Sample size include 105 patients dividing in three equal groups of Povidone-iodine, Chlorhexidine and Normal saline randomly. Interventions are Washing perinea area and catheter first 5 centimeters by 15 ml of Povidone-iodine 10%, Chlorhexidine .2% or Normal saline .9%, 3 times a day for 10 days. Urine analysis are performed in days 1,3,5,7 and 9 after catheterization and urine cultures are performed in days 5 and 10 after catheterization for detection of bacteriuria and microorganism type.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Urinary Tract Infection
  • Nosocomial Infection
  • Bacteriuria
Intervention  ICMJE
  • Drug: Povidone-iodine
    15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
    Other Name: Betadine
  • Drug: Chlorhexidine
    15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
    Other Name: CHLORHEXIDINE GLUCONATE
  • Drug: Normal saline
    15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
    Other Name: Chloride Sodium
Study Arms  ICMJE
  • Experimental: Chlorhexidine
    Washing of perineal area and proximal first 5 centimeters of catheter from mea, done by 15 ml of Chlorhexidine 0.2%, 3 times a day for 10 days.
    Intervention: Drug: Chlorhexidine
  • Experimental: Povidone-Iodine
    Washing of perineal area and proximal first 5 centimeters of catheter from mea, done by 15 ml of Povidone-iodine 10%, 3 times a day for 10 days.
    Intervention: Drug: Povidone-iodine
  • Active Comparator: Normal saline
    Washing of perineal area and proximal first 5 centimeters of catheter from mea, done by 15 ml of Normal saline 0.9%, 3 times a day for 10 days.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must need a urinary catheter for 10 days at least
  • Must have 18-55 years old
  • Men subjects must doing circumcision already
  • Urinary catheter must be apply in a standard method by researcher or via her supervision

Exclusion Criteria:

  • No more tendency of patient or his/her significant other for continuing study
  • Malignant disease such as prostate or uterine cancer
  • History of recurrent urinary infection
  • Congenital urinary system disorders
  • history of allergy
  • Immunodeficiency disorders
  • Urinary system intervention in past sixth months
  • Urinary infection at study start
  • Positive urine analysis or urine culture results in first 3 days of study
  • Abdominal or pelvic surgery
  • Women having period during study
  • Any allergic reaction or dermatitis resulted from applying study solutions
  • Appearing genital wounds
  • Diabetes mellitus
  • Wound in genital area
  • Discharging, transferring or dying in first week of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032394
Other Study ID Numbers  ICMJE MUMS910212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seyedreza Mazloum, Mashhad University of Medical Sciences
Study Sponsor  ICMJE Mashhad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Seyedreza Mazloum, Ph.D. Medical Surgical Nursing Department, Mashhad University of Medical Sciences
Study Director: Kamran Mohammadnia, Ms. Postgraduate Department, Mashhad University of Medical Sciences
Study Director: Tayyebe Pourghaznein, Ms. Medical Surgical Nursing Department, Mashhad University of Medical Sciences
Study Director: Ebrahim Alijanpoor, Specialist Anesthesia Department, Babol University of medical scienses
PRS Account Mashhad University of Medical Sciences
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP