Clinical Trial: Effect of Chlorhexidine on Bacteriuria

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Inte

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 Summary: 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.
Sponsor: Mashhad University of Medical Sciences

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Mashhad University of Medical Sciences

Dates:
Date Received: January 7, 2014
Date Started: July 2013
Date Completion: April 2014
Last Updated: January 8, 2014
Last Verified: January 2014