Title

Effect of Chlorhexidine on Bacteriuria
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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    105
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.
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 Started
Jul 31
2013
Primary Completion
Feb 28
2014
Anticipated
Study Completion
Apr 30
2014
Anticipated
Last Update
Jan 10
2014
Estimate

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 names: 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 names: 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 names: Chloride Sodium

Chlorhexidine Experimental

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.

Povidone-Iodine Experimental

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.

Normal saline Active Comparator

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.

Criteria

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
No Results Posted